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safetyreportid
int64
safetyreportversion
int64
occurcountry
string
reporttype
string
serious
string
serious_specific
string
receivedate
int64
transmissiondate
int64
companynumb
string
sendertype
string
senderorganization
string
patientonsetage
float64
patientonsetageunit
string
patientsex
string
reactions
string
drugs_specific
string
drugnames
string
activesubstancenames
string
drugindications
string
10,039,600
8
United States of America
Report from study
Yes
Hospitalization (Yes); Other (Yes)
20,140,326
20,180,711
US-SANOFI-AVENTIS-2013SA074519
Regulatory Authority
FDA-Public Use
47
Year
Female
Arthralgia (Not Recovered / Not Resolved / Ongoing); Weight decreased (Recovering / Resolving); Onychomadesis (Not Recovered / Not Resolved / Ongoing); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Fall (Recovered / Resolved); Mood swings (Not Recovered / Not Resolved / Ongoing); Wound (Recovered / Resolved); Asthenia (Not Recovered / Not Resolved / Ongoing)
AUBAGIO (Suspect), Active: TERIFLUNOMIDE, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
['aubagio']
['teriflunomide']
['multiple sclerosis']
10,032,873
3
United States of America
Report from study
Yes
Other (Yes)
20,140,324
20,180,711
US-SA-2014SA003859
Regulatory Authority
FDA-Public Use
37
Year
Female
Atypical pneumonia (Recovered / Resolved); Alopecia (Not Recovered / Not Resolved / Ongoing); Paraesthesia (Not Recovered / Not Resolved / Ongoing); Multiple sclerosis relapse (Recovering / Resolving); Ankle fracture (Recovering / Resolving)
AUBAGIO (Suspect), Active: TERIFLUNOMIDE, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: Yes
['aubagio']
['teriflunomide']
['multiple sclerosis']
10,078,908
3
Brazil
Spontaneous
Yes
Death (Yes); Other (Yes)
20,140,415
20,180,711
BR-ALEXION PHARMACEUTICALS INC.-A201401198
Regulatory Authority
FDA-Public Use
28
Year
Female
Cerebral haemorrhage (Fatal); Cardiac arrest (Fatal)
SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: UNK, Action: Not applicable; SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: 900 MG, SINGLE, Indication: ATYPICAL HAEMOLYTIC URAEMIC SYNDROME, Action: Not applicable
['soliris']
['eculizumab']
['atypical haemolytic uraemic syndrome']
12,168,459
17
Canada
Report from study
Yes
Hospitalization (Yes); Other (Yes)
20,160,310
20,180,711
PHHY2016CA018141
Regulatory Authority
FDA-Public Use
77
Year
Female
Dyspnoea (Recovering / Resolving); Choking (Recovering / Resolving); Contusion (Recovered / Resolved)
SANDOSTATIN (Suspect), Active: OCTREOTIDE ACETATE, Dosage: UNK UNK, ONCE/SINGLE, Indication: CARCINOID TUMOUR, Action: Not applicable; SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 30 MG, QMO (EVERY 4 WEEKS), Action: Dose Increased; SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 20 MG, QMO (EVERY 4 WEEKS), Indication: CARCINOID TUMOUR, Action: Dose Increased
['sandostatin lar depot', 'sandostatin']
['octreotide acetate']
['carcinoid tumour']
12,147,792
4
Japan
Report from study
Yes
Death (Yes); Other (Yes)
20,160,304
20,180,711
JP-009507513-1603JPN002733
Regulatory Authority
FDA-Public Use
74
Year
Male
Septic shock (Fatal)
CUBICIN (Suspect), Active: DAPTOMYCIN, Dosage: 8 MG/KG, QOD, Indication: STAPHYLOCOCCAL SEPSIS, Action: Not applicable
['cubicin']
['daptomycin']
['staphylococcal sepsis']
12,202,591
5
Germany
Spontaneous
Yes
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
20,160,322
20,180,711
DE-GILEAD-2016-0203424
Regulatory Authority
FDA-Public Use
65
Year
Male
Candida infection (Fatal); Nausea (Fatal); Portal fibrosis (Fatal); Cholestasis (Fatal); Acute hepatic failure (Fatal); Hepatic enzyme increased (Fatal); Hyperferritinaemia (Fatal); Hypovolaemic shock (Fatal); Hepatic necrosis (Fatal); Hypoxia (Fatal); Thrombocytopenia (Fatal); Lymphadenopathy (Fatal); Circulatory collapse (Fatal); Cholangitis (Fatal); Hepatic failure (Fatal); Fatigue (Fatal); Hepatitis (Fatal); Coagulopathy (Fatal); Ocular icterus (Fatal); Decreased appetite (Fatal); Multiple organ dysfunction syndrome (Fatal); Neutropenia (Fatal); Sepsis (Fatal); Bone marrow failure (Fatal); Duodenal ulcer (Fatal); Hepatotoxicity (Fatal); Jaundice (Fatal); Pneumonia (Fatal); Faeces pale (Fatal); Splenomegaly (Fatal); Renal failure (Fatal); Weight decreased (Fatal); Leukopenia (Fatal); Drug-induced liver injury (Fatal); Metabolic acidosis (Fatal); Agranulocytosis (Fatal); Acidosis (Fatal); Shock haemorrhagic (Fatal); Pancytopenia (Fatal); Hepatitis cholestatic (Fatal); Pyrexia (Fatal); Drug interaction (Fatal); Upper gastrointestinal haemorrhage (Fatal); Hepatomegaly (Fatal); Abdominal pain upper (Fatal); Confusional state (Fatal); General physical health deterioration (Fatal); Disseminated intravascular coagulation (Fatal); Hepatitis fulminant (Fatal); Asthenia (Fatal); Neutropenic sepsis (Fatal); Hepatic function abnormal (Fatal); Abdominal pain (Fatal); Chromaturia (Fatal)
TRUVADA (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE, Dosage: 1 DF, QD, Indication: HIV INFECTION, Action: Drug Withdrawn
['truvada']
['emtricitabine\\tenofovir disoproxil fumarate']
['hiv infection']
12,188,739
5
United States of America
Report from study
Yes
Other (Yes)
20,160,317
20,180,711
PHHY2016US019346
Regulatory Authority
FDA-Public Use
62
Year
Female
Occipital neuralgia (Recovered / Resolved); Blood alkaline phosphatase increased (Recovered / Resolved); Alanine aminotransferase increased (Recovered / Resolved)
GILENYA (Suspect), Active: FINGOLIMOD HYDROCHLORIDE, Dosage: QD, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
['gilenya']
['fingolimod hydrochloride']
['multiple sclerosis']
12,209,347
4
Sweden
Spontaneous
Yes
Death (Yes)
20,160,324
20,180,711
SE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-18364SW
Regulatory Authority
FDA-Public Use
45
Year
Female
General physical health deterioration (Fatal); Dyspnoea (Fatal); Arterial thrombosis (Fatal)
VARGATEF (Suspect), Active: NINTEDANIB, Indication: LUNG ADENOCARCINOMA, Action: Unknown, Additional: Doesn't Apply
['vargatef']
['nintedanib']
['lung adenocarcinoma']
12,153,590
6
United States of America
Report from study
Yes
Other (Yes)
20,160,307
20,180,711
US-AMGEN-USASL2016025789
Regulatory Authority
FDA-Public Use
55
Year
Female
Malaise (Not Recovered / Not Resolved / Ongoing); Injection site rash (Recovered / Resolved); Injection site erythema (Recovered / Resolved); Injection site swelling (Recovered / Resolved)
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
['enbrel']
['etanercept']
['rheumatoid arthritis']
12,211,127
3
United States of America
Report from study
Yes
Hospitalization (Yes)
20,160,325
20,180,711
US-BIOGEN-2016BI00207761
Regulatory Authority
FDA-Public Use
50
Year
Female
Seizure (Recovered / Resolved)
TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: Yes; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Dosage: MAINTENANCE DOSE, Action: Drug Withdrawn, Additional: Yes
['tecfidera']
['dimethyl fumarate']
['multiple sclerosis']
12,161,533
5
Germany
Report from study
Yes
Hospitalization (Yes)
20,160,309
20,180,711
DE-ROCHE-1642221
Regulatory Authority
FDA-Public Use
73
Year
Male
Procedural complication (Recovered / Resolved); Colonic abscess (Recovered / Resolved); Fistula (Recovered / Resolved); Procedural complication (Recovered / Resolved); Abdominal pain lower (Recovered / Resolved); Pyrexia (Recovered / Resolved)
BEVACIZUMAB. (Suspect), Active: BEVACIZUMAB, Indication: COLORECTAL CANCER METASTATIC, Action: Drug Withdrawn, Additional: Yes
['bevacizumab.']
['bevacizumab']
['colorectal cancer metastatic']
12,162,900
4
Germany
Report from study
Yes
Hospitalization (Yes)
20,160,309
20,180,711
DE-ABBVIE-16K-062-1571851-00
Regulatory Authority
FDA-Public Use
65
Year
Male
Gout (Recovered / Resolved); Dry skin (Not Recovered / Not Resolved / Ongoing); Eyelid skin dryness (Not Recovered / Not Resolved / Ongoing); Cardiac failure (Not Recovered / Not Resolved / Ongoing)
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Dose not changed; HUMIRA (Suspect), Active: ADALIMUMAB, Action: Drug Withdrawn, Additional: Yes; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: Yes
['humira']
['adalimumab']
['crohn^s disease']
12,195,004
5
Canada
Report from study
Yes
Other (Yes)
20,160,321
20,180,711
CA-APOPHARMA-2015AP014253
Regulatory Authority
FDA-Public Use
77
Year
Male
Serum ferritin increased (Recovering / Resolving)
FERRIPROX (Suspect), Active: DEFERIPRONE, Dosage: 24 MG/KG, TID, Indication: MYELODYSPLASTIC SYNDROME, Action: Dose Increased; FERRIPROX (Suspect), Active: DEFERIPRONE, Dosage: 99 MG/KG, QD, Action: Dose Increased
['ferriprox']
['deferiprone']
['myelodysplastic syndrome']
13,164,616
3
India
Spontaneous
Yes
Disabling (Yes); Hospitalization (Yes)
20,170,130
20,180,711
ALCN2017IN000961
Regulatory Authority
FDA-Public Use
61
Year
Male
Eye pain (Not Recovered / Not Resolved / Ongoing); Eye oedema (Not Recovered / Not Resolved / Ongoing); Endophthalmitis (Not Recovered / Not Resolved / Ongoing); Corneal oedema (Not Recovered / Not Resolved / Ongoing); Lacrimation increased (Not Recovered / Not Resolved / Ongoing); Hypopyon (Not Recovered / Not Resolved / Ongoing); Ocular hyperaemia (Not Recovered / Not Resolved / Ongoing); Corneal infiltrates (Not Recovered / Not Resolved / Ongoing)
BSS (Suspect), Active: CALCIUM CHLORIDE\MAGNESIUM CHLORIDE\POTASSIUM CHLORIDE\SODIUM ACETATE\SODIUM CHLORIDE\SODIUM CITRATE, Dosage: UNK, ONCE/SINGLE, Indication: CATARACT OPERATION, Action: Not applicable
['bss']
['calcium chloride\\magnesium chloride\\potassium chloride\\sodium acetate\\sodium chloride\\sodium citrate']
['cataract operation']
13,174,218
4
United States of America
Spontaneous
No
null
20,170,201
20,180,711
US-PFIZER INC-2017043271
Regulatory Authority
FDA-Public Use
65
Year
Female
Pain (Recovered / Resolved); Myalgia (Recovered / Resolved)
ATORVASTATIN CALCIUM. (Suspect), Active: ATORVASTATIN CALCIUM, Dosage: UNK, Action: Drug Withdrawn, Additional: Yes
['atorvastatin calcium.']
['atorvastatin calcium']
[]
13,164,617
3
India
Spontaneous
Yes
Hospitalization (Yes)
20,170,130
20,180,711
ALCN2017IN000957
Regulatory Authority
FDA-Public Use
56
Year
Female
Endophthalmitis (Not Recovered / Not Resolved / Ongoing); Eye pain (Not Recovered / Not Resolved / Ongoing); Lacrimation increased (Not Recovered / Not Resolved / Ongoing); Eye oedema (Not Recovered / Not Resolved / Ongoing); Metamorphopsia (Not Recovered / Not Resolved / Ongoing); Ocular hyperaemia (Not Recovered / Not Resolved / Ongoing)
BETADINE (Suspect), Active: POVIDONE-IODINE, Indication: INTRAOPERATIVE CARE, Action: Unknown, Additional: Doesn't Apply; BSS (Suspect), Active: CALCIUM CHLORIDE\MAGNESIUM CHLORIDE\POTASSIUM CHLORIDE\SODIUM ACETATE\SODIUM CHLORIDE\SODIUM CITRATE, Dosage: UNK UNK, ONCE/SINGLE, Indication: CATARACT OPERATION, Action: Not applicable
['bss', 'betadine']
['povidone-iodine', 'calcium chloride\\magnesium chloride\\potassium chloride\\sodium acetate\\sodium chloride\\sodium citrate']
['cataract operation', 'intraoperative care']
13,188,648
3
United States of America
Spontaneous
Yes
Other (Yes)
20,170,206
20,180,711
US-RECKITT BENCKISER HEALTHCARE INT LIMITED-RB-81315-2017
Regulatory Authority
FDA-Public Use
44
Year
Male
Anxiety (Recovered / Resolved); Nervousness (Recovered / Resolved); Insomnia (Recovered / Resolved); Overdose (Recovered / Resolved); Feeling jittery (Recovered / Resolved); Incorrect drug administration duration (Recovered / Resolved)
MUCINEX DM MAXIMUM STRENGTH (Suspect), Active: DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN, Dosage: 2400 MG, SINGLE, IN EVENING, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; MUCINEX D (Suspect), Active: GUAIFENESIN\PSEUDOEPHEDRINE HYDROCHLORIDE, Dosage: 1200 MG, SINGLE, IN MORNING, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
['mucinex d', 'mucinex dm maximum strength']
['dextromethorphan hydrobromide\\guaifenesin', 'guaifenesin\\pseudoephedrine hydrochloride']
['product used for unknown indication']
13,195,831
3
Brazil
Report from study
Yes
Other (Yes)
20,170,208
20,180,711
PHHY2017BR016859
Regulatory Authority
FDA-Public Use
51
Year
Female
Leukopenia (Not Recovered / Not Resolved / Ongoing); Cholelithiasis (Not Recovered / Not Resolved / Ongoing); Abdominal pain (Not Recovered / Not Resolved / Ongoing); Laryngitis (Not Recovered / Not Resolved / Ongoing); Sinusitis (Not Recovered / Not Resolved / Ongoing); Gamma-glutamyltransferase increased (Not Recovered / Not Resolved / Ongoing); Alopecia (Not Recovered / Not Resolved / Ongoing); Herpes zoster (Not Recovered / Not Resolved / Ongoing); Flatulence (Not Recovered / Not Resolved / Ongoing); Onychoclasis (Not Recovered / Not Resolved / Ongoing); Liver disorder (Not Recovered / Not Resolved / Ongoing); Pharyngitis (Not Recovered / Not Resolved / Ongoing); Decreased immune responsiveness (Not Recovered / Not Resolved / Ongoing)
GILENYA (Suspect), Active: FINGOLIMOD HYDROCHLORIDE, Dosage: 0.5 MG, QD, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: No
['gilenya']
['fingolimod hydrochloride']
['multiple sclerosis']
13,196,091
3
Italy
Spontaneous
Yes
Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
20,170,208
20,180,711
IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2017RR-131290
Regulatory Authority
FDA-Public Use
86
Year
Female
Lactic acidosis (Recovered / Resolved); Acute kidney injury (Recovered / Resolved); Cardiac arrest (Recovered / Resolved)
METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Dosage: 1750 MG, DAILY, Indication: DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply; TRIATEC (RAMIPRIL) (Suspect), Active: RAMIPRIL, Dosage: 2.5 MG, DAILY, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; CARDIO ASA (Suspect), Active: ASPIRIN, Dosage: 100 MG, DAILY, Indication: ANGIOPATHY, Action: Unknown, Additional: Doesn't Apply
['triatec (ramipril)', 'metformin', 'cardio asa']
['ramipril', 'aspirin', 'metformin hydrochloride']
['diabetes mellitus', 'hypertension', 'angiopathy']
13,202,387
3
United States of America
Spontaneous
No
null
20,170,209
20,180,711
US-PFIZER INC-2017055316
Regulatory Authority
FDA-Public Use
59
Year
Female
Discomfort (Recovered / Resolved); Abdominal distension (Recovered / Resolved); Pain in extremity (Recovered / Resolved); Peripheral swelling (Recovered / Resolved); Hyperhidrosis (Recovered / Resolved)
LYRICA (Suspect), Active: PREGABALIN, Dosage: 50 MG, 2X/DAY, Indication: NEURALGIA, Action: Drug Withdrawn, Additional: Yes
['lyrica']
['pregabalin']
['neuralgia']
13,181,752
6
United States of America
Spontaneous
Yes
Hospitalization (Yes)
20,170,202
20,180,711
US-ACTELION-A-US2017-149411
Regulatory Authority
FDA-Public Use
66
Year
Female
Bradycardia (Recovering / Resolving); Palpitations (Recovering / Resolving)
OPSUMIT (Suspect), Active: MACITENTAN, Dosage: 10 MG, QD, Indication: PULMONARY HYPERTENSION, Action: Unknown, Additional: Doesn't Apply
['opsumit']
['macitentan']
['pulmonary hypertension']
13,192,887
2
United States of America
Report from study
Yes
Hospitalization (Yes); Other (Yes)
20,170,207
20,180,711
US-GLAXOSMITHKLINE-US2016172813
Regulatory Authority
FDA-Public Use
68
Year
Male
Carotid artery stenosis (Recovered / Resolved); Bradycardia (Recovered / Resolved)
BLINDED PLACEBO (Suspect), Active: INVESTIGATIONAL PRODUCT, Dosage: 30 MG, WE, Indication: TYPE 2 DIABETES MELLITUS, Action: Dose not changed; BLINDED ALBIGLUTIDE (Suspect), Active: ALBIGLUTIDE, Dosage: 30 MG, WE, Indication: TYPE 2 DIABETES MELLITUS, Action: Dose not changed; AMIODARONE (Suspect), Active: AMIODARONE, Dosage: 200 MG, 1D, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; COREG (Suspect), Active: CARVEDILOL, Dosage: 6.25 MG, BID, Indication: HYPERTENSION, Action: Drug Withdrawn, Additional: Yes
['blinded placebo', 'coreg', 'blinded albiglutide', 'amiodarone']
['amiodarone', 'carvedilol', 'investigational product', 'albiglutide']
['hypertension', 'type 2 diabetes mellitus', 'atrial fibrillation']
13,183,921
2
Canada
Report from study
Yes
Death (Yes); Hospitalization (Yes)
20,170,203
20,180,711
CA-ROCHE-1883836
Regulatory Authority
FDA-Public Use
null
null
null
Acute hepatic failure (Fatal); Hepatitis B reactivation (Fatal)
PREDNISONE. (Suspect), Active: PREDNISONE, Indication: GUILLAIN-BARRE SYNDROME, Action: Unknown, Additional: Doesn't Apply; IVIG (Suspect), Active: HUMAN IMMUNOGLOBULIN G, Indication: GUILLAIN-BARRE SYNDROME, Action: Unknown, Additional: Doesn't Apply; MYCOPHENOLATE MOFETIL. (Suspect), Active: MYCOPHENOLATE MOFETIL, Indication: GUILLAIN-BARRE SYNDROME, Action: Unknown, Additional: Doesn't Apply
['ivig', 'prednisone.', 'mycophenolate mofetil.']
['human immunoglobulin g', 'mycophenolate mofetil', 'prednisone']
['guillain-barre syndrome']
13,194,238
5
United States of America
Spontaneous
Yes
Hospitalization (Yes); Other (Yes)
20,170,207
20,180,711
US-ACORDA-ACO_133474_2017
Regulatory Authority
FDA-Public Use
58
Year
Female
Pericardial effusion (Recovered / Resolved); Lymphopenia (Recovered / Resolved); Vomiting (Recovered / Resolved); Fall (Not Recovered / Not Resolved / Ongoing); Cardioversion (Not Recovered / Not Resolved / Ongoing); Influenza like illness (Recovered / Resolved); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Condition aggravated (Not Recovered / Not Resolved / Ongoing); Peroneal nerve palsy (Not Recovered / Not Resolved / Ongoing); Tooth fracture (Recovered / Resolved)
XARELTO (Suspect), Active: RIVAROXABAN, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Dosage: 120 MG, BID (STARTING DOSE), Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: Yes; AMPYRA (Suspect), Active: DALFAMPRIDINE, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Dosage: 240 MG, BID (MAINTENANCE DOSE), Action: Drug Withdrawn, Additional: Yes; AMPYRA (Suspect), Active: DALFAMPRIDINE, Dosage: 10 MG, BID, Indication: GAIT DISTURBANCE, Action: Dose not changed
['ampyra', 'xarelto', 'tecfidera']
['dalfampridine', 'dimethyl fumarate', 'rivaroxaban']
['product used for unknown indication', 'gait disturbance', 'multiple sclerosis']
13,801,085
3
South Africa
Spontaneous
Yes
Hospitalization (Yes); Other (Yes)
20,170,727
20,180,711
ZA-BAUSCH-BL-2017-022371
Regulatory Authority
FDA-Public Use
3
Year
Male
Linear IgA disease (Recovered / Resolved with Sequelae); Erythema multiforme (Recovered / Resolved with Sequelae)
CYCLIZINE (Suspect), Active: CYCLIZINE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; AMOXICILLIN/CLAVULANIC ACID (Suspect), Active: AMOXICILLIN\CLAVULANIC ACID, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; GOLDGESIC (Suspect), Active: ACETAMINOPHEN\CODEINE PHOSPHATE\PROMETHAZINE HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; SULFAMETHOXAZOLE, TRIMETHOPRIM (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; GRISEOFULVIN. (Suspect), Active: GRISEOFULVIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; TETMOSOL (Suspect), Active: SULFIRAM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; CHLORPHENAMINE MALEATE (Suspect), Active: CHLORPHENIRAMINE MALEATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; COTRIMOXAZOLE (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; RETAPAMULIN (Suspect), Active: RETAPAMULIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; CLOXACILLIN (Suspect), Active: CLOXACILLIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
['amoxicillin/clavulanic acid', 'retapamulin', 'cotrimoxazole', 'cloxacillin', 'tetmosol', 'goldgesic', 'cyclizine', 'chlorphenamine maleate', 'sulfamethoxazole, trimethoprim', 'griseofulvin.']
['sulfamethoxazole\\trimethoprim', 'sulfiram', 'amoxicillin\\clavulanic acid', 'retapamulin', 'cloxacillin', 'acetaminophen\\codeine phosphate\\promethazine hydrochloride', 'griseofulvin', 'cyclizine', 'chlorpheniramine maleate']
['product used for unknown indication']
13,790,768
2
United States of America
Spontaneous
No
null
20,170,725
20,180,711
US-GALDERMA-US17003884
Regulatory Authority
FDA-Public Use
null
null
Female
Erythema (Recovered / Resolved); Skin irritation (Recovered / Resolved); Skin sensitisation (Recovered / Resolved)
DIFFERIN GEL (Suspect), Active: ADAPALENE, Dosage: 0.1%, Indication: ACNE, Action: Drug Withdrawn, Additional: Yes
['differin gel']
['adapalene']
['acne']
13,791,179
6
United States of America
Spontaneous
Yes
Hospitalization (Yes); Other (Yes)
20,170,725
20,180,711
US-INCYTE CORPORATION-2017IN005593
Regulatory Authority
FDA-Public Use
null
null
null
Peripheral swelling (Not Recovered / Not Resolved / Ongoing); White blood cell disorder (Recovered / Resolved); Swelling (Recovering / Resolving); Contusion (Recovering / Resolving)
JAKAFI (Suspect), Active: RUXOLITINIB, Dosage: 5 MG, BID, Action: Drug Withdrawn, Additional: Yes; JAKAFI (Suspect), Active: RUXOLITINIB, Dosage: 5 MG, BID, Indication: MYELOFIBROSIS, Action: Drug Withdrawn, Additional: Yes; JAKAFI (Suspect), Active: RUXOLITINIB, Dosage: 10 MG, BID, Action: Drug Withdrawn, Additional: Yes
['jakafi']
['ruxolitinib']
['myelofibrosis']
13,795,399
2
United States of America
Not available to sender (unknown)
No
null
20,170,726
20,180,711
US-NEUROCRINE BIOSCIENCES INC.-2017NBI00461
Regulatory Authority
FDA-Public Use
64
Year
Male
Fatigue (Recovering / Resolving); Secretion discharge (Recovering / Resolving)
INGREZZA (Suspect), Active: VALBENAZINE, Indication: TARDIVE DYSKINESIA, Action: Dose not changed
['ingrezza']
['valbenazine']
['tardive dyskinesia']
13,795,451
2
United States of America
Not available to sender (unknown)
No
null
20,170,726
20,180,711
US-NEUROCRINE BIOSCIENCES INC.-2017NBI00451
Regulatory Authority
FDA-Public Use
65
Year
Female
Urticaria (Not Recovered / Not Resolved / Ongoing)
INGREZZA (Suspect), Active: VALBENAZINE, Indication: TARDIVE DYSKINESIA, Action: Dose not changed
['ingrezza']
['valbenazine']
['tardive dyskinesia']
13,791,404
3
Germany
Report from study
Yes
Life-threatening (Yes); Other (Yes)
20,170,725
20,180,711
PHHY2016DE001780
Regulatory Authority
FDA-Public Use
47
Year
Female
White blood cell count increased (Recovered / Resolved); White blood cell count decreased (Recovered / Resolved); Lymphopenia (Recovering / Resolving); Alanine aminotransferase increased (Recovered / Resolved); Alanine aminotransferase increased (Recovered / Resolved)
GILENYA (Suspect), Active: FINGOLIMOD HYDROCHLORIDE, Dosage: 0.5 MG, QD, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
['gilenya']
['fingolimod hydrochloride']
['multiple sclerosis']
13,783,871
7
United States of America
Spontaneous
Yes
Hospitalization (Yes); Other (Yes)
20,170,724
20,180,711
US-BIOGEN-2014BI072335
Regulatory Authority
FDA-Public Use
62
Year
Male
Carotid arteriosclerosis (Recovered / Resolved); Confusional state (Not Recovered / Not Resolved / Ongoing); Post procedural stroke (Recovered / Resolved); Cerebrovascular accident (Not Recovered / Not Resolved / Ongoing)
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: Yes; AVONEX (Suspect), Active: INTERFERON BETA-1A, Action: Drug Withdrawn, Additional: Yes
['avonex']
['interferon beta-1a']
['multiple sclerosis']
13,791,669
5
Japan
Report from study
Yes
Other (Yes)
20,170,725
20,180,711
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-066120
Regulatory Authority
FDA-Public Use
66
Year
Female
Myalgia (Recovering / Resolving); Fatigue (Recovered / Resolved); Hyperthyroidism (Recovered / Resolved); Diarrhoea (Recovering / Resolving); Atrial fibrillation (Recovering / Resolving); Hypothyroidism (Recovered / Resolved); Stomatitis (Recovered / Resolved)
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, UNK, Indication: MALIGNANT MELANOMA, Action: Drug Withdrawn, Additional: Yes
['nivolumab']
['nivolumab']
['malignant melanoma']
13,804,565
2
United States of America
Spontaneous
No
null
20,170,728
20,180,711
US-ASTRAZENECA-2017SE74242
Regulatory Authority
FDA-Public Use
64
Year
Male
Stubbornness (Not Recovered / Not Resolved / Ongoing); Sleep apnoea syndrome (Not Recovered / Not Resolved / Ongoing); Device use issue (Not Recovered / Not Resolved / Ongoing); Intentional product misuse (Not Recovered / Not Resolved / Ongoing)
TUDORZA PRESSAIR (Suspect), Active: ACLIDINIUM BROMIDE, Dosage: 1 PUFF ONCE DAILY, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed; TUDORZA PRESSAIR (Suspect), Active: ACLIDINIUM BROMIDE, Dosage: 400 MCG 1 PUFF TWICE A DAY, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed; METOPROLOL SUCCINATE. (Suspect), Active: METOPROLOL SUCCINATE, Indication: BLOOD CHOLESTEROL, Action: Dose not changed; SYMBICORT (Suspect), Active: BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE, Dosage: 160/4.5 MCG 2 PUFFS TWICE A DAY, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed
['metoprolol succinate.', 'tudorza pressair', 'symbicort']
['aclidinium bromide', 'budesonide\\formoterol fumarate dihydrate', 'metoprolol succinate']
['chronic obstructive pulmonary disease', 'blood cholesterol']
13,796,963
4
Italy
Spontaneous
Yes
Other (Yes)
20,170,726
20,180,711
PHHY2017IT107928
Regulatory Authority
FDA-Public Use
70
Year
Male
Pain (Recovered / Resolved with Sequelae); Osteonecrosis of jaw (Recovered / Resolved with Sequelae); Hypoaesthesia oral (Recovered / Resolved with Sequelae); Osteonecrosis (Recovered / Resolved with Sequelae); Pain in jaw (Recovered / Resolved with Sequelae)
ZOMETA (Suspect), Active: ZOLEDRONIC ACID, Dosage: UNK MG, UNK, Indication: PROSTATE CANCER METASTATIC, Action: Unknown, Additional: Doesn't Apply
['zometa']
['zoledronic acid']
['prostate cancer metastatic']
13,802,378
3
France
Spontaneous
Yes
Disabling (Yes); Hospitalization (Yes); Other (Yes)
20,170,727
20,180,711
FR-GILEAD-2017-0284666
Regulatory Authority
FDA-Public Use
45
Year
Male
Multiple fractures (Recovered / Resolved with Sequelae); Blood phosphorus decreased (Recovered / Resolved with Sequelae); Hypokalaemia (Recovered / Resolved with Sequelae); Osteomalacia (Recovered / Resolved with Sequelae)
TRUVADA (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE, Dosage: UNK, Action: Drug Withdrawn, Additional: Yes; TRUVADA (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE, Dosage: 1 DF, QD, Indication: HIV INFECTION, Action: Drug Withdrawn, Additional: Yes
['truvada']
['emtricitabine\\tenofovir disoproxil fumarate']
['hiv infection']
13,788,626
4
United States of America
Spontaneous
Yes
Other (Yes)
20,170,725
20,180,711
US-APOTEX-2017AP015760
Regulatory Authority
FDA-Public Use
74
Year
Male
Myotonic dystrophy (Recovered / Resolved); Myalgia (Recovered / Resolved); Condition aggravated (Recovered / Resolved)
COENZYME Q10 (Suspect), Active: UBIDECARENONE, Dosage: UNKNOWN, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply; SIMVASTATIN. (Suspect), Active: SIMVASTATIN, Indication: HYPERCHOLESTEROLAEMIA, Action: Dose reduced, Additional: Yes; ROSUVASTATIN CALCIUM TABLETS (Suspect), Active: ROSUVASTATIN CALCIUM, Dosage: 5 MG, THREE TIMES PER WEEK, Indication: CORONARY ARTERY DISEASE, Action: Drug Withdrawn, Additional: Yes; PRAVASTATIN. (Suspect), Active: PRAVASTATIN, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply; ALIROCUMAB (Suspect), Active: ALIROCUMAB, Dosage: 75 MG S.C EVERY TWO WEEKS, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply; EZETIMIBE. (Suspect), Active: EZETIMIBE, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply; ATORVASTATIN CALCIUM. (Suspect), Active: ATORVASTATIN CALCIUM, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply
['alirocumab', 'pravastatin.', 'ezetimibe.', 'simvastatin.', 'atorvastatin calcium.', 'rosuvastatin calcium tablets', 'coenzyme q10']
['simvastatin', 'alirocumab', 'ezetimibe', 'rosuvastatin calcium', 'atorvastatin calcium', 'pravastatin', 'ubidecarenone']
['hypercholesterolaemia', 'coronary artery disease']
13,789,725
2
United States of America
Spontaneous
Yes
Hospitalization (Yes); Other (Yes)
20,170,725
20,180,711
US-LEXICON PHARMACEUTICALS, INC-17-1606-00559
Regulatory Authority
FDA-Public Use
59
Year
Male
Cellulitis (Recovering / Resolving); Asthenia (Not Recovered / Not Resolved / Ongoing); Peripheral swelling (Recovering / Resolving); Feeding disorder (Not Recovered / Not Resolved / Ongoing); Weight decreased (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing); Hospitalisation (Not Recovered / Not Resolved / Ongoing); Pain in extremity (Not Recovered / Not Resolved / Ongoing); Haemoglobin decreased (Not Recovered / Not Resolved / Ongoing)
TELOTRISTAT ETHYL (Suspect), Active: TELOTRISTAT ETHYL, Indication: CARCINOID TUMOUR, Action: Drug Withdrawn, Additional: Yes
['telotristat ethyl']
['telotristat ethyl']
['carcinoid tumour']
13,794,357
9
Japan
Spontaneous
Yes
Death (Yes); Other (Yes)
20,170,726
20,180,711
JP-009507513-1707JPN000248J
Regulatory Authority
FDA-Public Use
67
Year
Male
Pneumonitis (Fatal); Malignant neoplasm progression (Fatal)
KEYTRUDA (Suspect), Active: PEMBROLIZUMAB, Dosage: 200 MG, Q3W, Indication: SQUAMOUS CELL CARCINOMA OF LUNG, Action: Drug Withdrawn
['keytruda']
['pembrolizumab']
['squamous cell carcinoma of lung']
13,798,392
2
United Kingdom of Great Britain and Northern Ireland
Spontaneous
Yes
Hospitalization (Yes); Life-threatening (Yes)
20,170,727
20,180,711
GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2017RR-146137
Regulatory Authority
FDA-Public Use
80
Year
Male
Gastrointestinal haemorrhage (Recovering / Resolving)
NICORANDIL (Suspect), Active: NICORANDIL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; SERTRALINE (Suspect), Active: SERTRALINE HYDROCHLORIDE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; WARFARIN (Suspect), Active: WARFARIN, Dosage: UNK, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes
['nicorandil', 'sertraline', 'warfarin']
['nicorandil', 'sertraline hydrochloride', 'warfarin']
['atrial fibrillation', 'product used for unknown indication']
13,798,667
4
United States of America
Spontaneous
No
null
20,170,727
20,180,711
US-JNJFOC-20170705789
Regulatory Authority
FDA-Public Use
78
Year
Female
Wrong technique in product usage process (Not Recovered / Not Resolved / Ongoing); Hair colour changes (Not Recovered / Not Resolved / Ongoing)
WOMENS ROGAINE UNSCENTED (Suspect), Active: MINOXIDIL, Action: Dose not changed; WOMENS ROGAINE UNSCENTED (Suspect), Active: MINOXIDIL, Dosage: SOMETIMES MORE OR LESS THAN 1/2 CAPFUL, Indication: ALOPECIA, Action: Dose not changed
['womens rogaine unscented']
['minoxidil']
['alopecia']
13,794,830
3
Germany
Spontaneous
Yes
Congenital anomaly (Yes); Disabling (Yes); Other (Yes)
20,170,726
20,180,711
DE-AMGEN-DEUSP2017046403
Regulatory Authority
FDA-Public Use
71
Year
Female
Anxiety (Recovered / Resolved); Hyperhidrosis (Recovered / Resolved); Depression (Recovering / Resolving); Herpes zoster (Recovering / Resolving); Cough (Recovered / Resolved); Influenza like illness (Recovered / Resolved)
PROLIA (Suspect), Active: DENOSUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
['prolia']
['denosumab']
['product used for unknown indication']
14,792,944
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027991
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,205
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028400
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,424
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029794
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,599
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028254
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,656
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029864
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,890
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028391
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,152
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027466
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,153
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028741
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,548
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027482
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,601
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027475
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,603
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027550
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,896
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029334
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,039
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027740
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,322
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027410
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,431
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028639
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,269
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028985
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,499
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028675
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,555
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028182
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,609
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027546
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,610
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029250
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,792
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029737
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,901
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028397
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,103
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027502
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,164
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-030102
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,218
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028404
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,219
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027752
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,611
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029256
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,612
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028255
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,961
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028405
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,741
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029858
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'nucynta', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,856
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-029585
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,908
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028415
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,111
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028746
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,172
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028709
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'nucynta', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'dilaudid', 'oxymorphone hcl']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,793,333
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-028654
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'fentanyl', 'buprenorphine', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
14,792,689
1
United States of America
Spontaneous
Yes
Death (Yes)
20,180,423
20,180,711
US-ENDO PHARMACEUTICALS INC-2018-027940
Regulatory Authority
FDA-Public Use
null
null
null
Death (Fatal)
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; SUBSYS (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'subsys', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'hydrocodone bitartrate', 'oxycodone hydrochloride', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
['pain']
End of preview. Expand in Data Studio

FAERS-NLP

Version: 1.0
Author: sixuexing GitHub: FAERS-NLP Repository


Dataset Summary

FAERS-NLP is a cleaned and processed version of the FDA Adverse Event Reporting System (FAERS), formatted for natural language retrieval and drug–adverse effect–disease relation extraction.

Each record corresponds to a single adverse event report, including structured and semi-structured fields suitable for NLP tasks.


Dataset Structure

Each CSV row contains the following columns:

Column Description
safetyreportid Unique ID of the safety report
safetyreportversion Version number of the report
occurcountry Country where the event occurred
reporttype Type of report (e.g., Study report, Spontaneous report)
serious Whether the event is serious (Yes/No)
serious_specific Specific seriousness criteria (e.g., Hospitalization)
receivedate Date FDA received the report (YYYYMMDD)
transmissiondate Date report was transmitted (YYYYMMDD)
companynumb Company identifier
sendertype Type of sender (Regulatory Authority, Manufacturer, etc.)
senderorganization Name of reporting organization
patientonsetage Patient age at onset
patientonsetageunit Unit of age (Year, Month, etc.)
patientsex Patient sex
reactions Adverse reactions reported (with recovery status)
drugs_specific Full description of drugs in report
drugnames List of drug names
activesubstancenames List of active substances
drugindications Indications for the drugs


FAERS source:
U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard. https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html

This dataset:
sixuexing. FAERS-NLP: A processed dataset for drug-adverse event-disease relation extraction. Hugging Face Dataset. Version 1.0. https://huggingface.co/datasets/sixuexing/FAERS-NLP

You can cite in BibTeX format:

@misc{faers-nlp,
  author = {Xing, Sixue},
  title = {FAERS-NLP: A processed dataset for drug-adverse event-disease relation extraction},
  year = {2025},
  howpublished = {\url{https://huggingface.co/datasets/sixuexing/FAERS-NLP}},
  note = {Derived from FDA FAERS public data: \url{https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html}}
}
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