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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
10,254,399
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,624
| 20,150,326
|
US-BIOGENIDEC-2014BI060049
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Influenza like illness (Not Recovered / Not Resolved / Ongoing); Neoplasm malignant (Recovered / Resolved); Gait disturbance (Not Recovered / Not Resolved / Ongoing)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,252,249
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,140,623
| 20,150,326
|
US-JNJFOC-20140608296
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Death (Fatal)
|
RITUXIMAB (Suspect), Active: RITUXIMAB, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Unknown; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Unknown; DOXORUBICIN (Suspect), Active: DOXORUBICIN, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Unknown; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Unknown; VINCRISTINE (Suspect), Active: VINCRISTINE, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Unknown
|
['cyclophosphamide.', 'vincristine', 'doxorubicin', 'rituximab', 'prednisolone.']
|
['vincristine', 'doxorubicin', 'rituximab', 'cyclophosphamide', 'prednisolone']
|
['diffuse large b-cell lymphoma']
|
10,250,493
| 2
|
Australia
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,620
| 20,150,326
|
AU-BRISTOL-MYERS SQUIBB COMPANY-20690939
|
Regulatory Authority
|
FDA-Public Use
| 83
|
Year
|
Female
|
Localised infection (Recovering / Resolving)
|
ORENCIA (Suspect), Active: ABATACEPT, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn
|
['orencia']
|
['abatacept']
|
['rheumatoid arthritis']
|
10,253,451
| 3
|
Italy
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,623
| 20,150,326
|
IT-ELI_LILLY_AND_COMPANY-IT201406004750
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Female
|
Intentional self-injury (Recovered / Resolved); Suicide attempt (Recovered / Resolved); Intentional overdose (Recovered / Resolved); Sopor (Recovered / Resolved)
|
FELISON (Suspect), Active: FLURAZEPAM MONOHYDROCHLORIDE, Dosage: 15 MG, UNKNOWN, Indication: INTENTIONAL SELF-INJURY, Action: Unknown; SEROQUEL (Suspect), Active: QUETIAPINE FUMARATE, Dosage: 200 MG, UNKNOWN, Indication: DEPRESSION, Action: Unknown; CYMBALTA (Suspect), Active: DULOXETINE HYDROCHLORIDE, Dosage: 60 MG, UNKNOWN, Indication: INTENTIONAL SELF-INJURY, Action: Dose not changed; XANAX (Suspect), Active: ALPRAZOLAM, Dosage: 0.5 MG, UNKNOWN, Indication: INTENTIONAL SELF-INJURY, Action: Unknown
|
['cymbalta', 'seroquel', 'felison', 'xanax']
|
['alprazolam', 'quetiapine fumarate', 'flurazepam monohydrochloride', 'duloxetine hydrochloride']
|
['intentional self-injury', 'depression']
|
10,253,455
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,623
| 20,150,326
|
US-ELI_LILLY_AND_COMPANY-US201406004288
|
Regulatory Authority
|
FDA-Public Use
| 64
|
Year
|
Male
|
Fall (Recovered / Resolved)
|
HUMALOG (Suspect), Active: INSULIN LISPRO, Dosage: 26 U, PRN, Indication: TYPE 2 DIABETES MELLITUS, Action: Dose not changed; HUMALOG (Suspect), Active: INSULIN LISPRO, Dosage: UNK, UNKNOWN, Indication: TYPE 2 DIABETES MELLITUS, Action: Unknown
|
['humalog']
|
['insulin lispro']
|
['type 2 diabetes mellitus']
|
10,251,058
| 3
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,620
| 20,150,326
|
JP-SUCAMPO PHARMA AMERICAS, INC-SPI201400424
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Female
|
Diarrhoea (Recovering / Resolving); Occult blood positive (Recovering / Resolving); Colitis microscopic (Recovering / Resolving)
|
AMITIZA (Suspect), Active: LUBIPROSTONE, Dosage: 24 MCG, UNK, Indication: CONSTIPATION, Action: Drug Withdrawn
|
['amitiza']
|
['lubiprostone']
|
['constipation']
|
10,250,561
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,620
| 20,150,326
|
US-GLAXOSMITHKLINE-A1077323A
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Lung disorder (Not Recovered / Not Resolved / Ongoing); Tremor (Not Recovered / Not Resolved / Ongoing); Cardiac disorder (Not Recovered / Not Resolved / Ongoing); Cold sweat (Not Recovered / Not Resolved / Ongoing); Panic attack (Not Recovered / Not Resolved / Ongoing); Chest discomfort (Not Recovered / Not Resolved / Ongoing); Feeling cold (Not Recovered / Not Resolved / Ongoing)
|
ADVAIR HFA (Suspect), Active: FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE, Dosage: 1PUFF PER DAY, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed
|
['advair hfa']
|
['fluticasone propionate\\salmeterol xinafoate']
|
['chronic obstructive pulmonary disease']
|
10,253,477
| 2
|
Italy
|
Spontaneous
|
Yes
|
Disabling (Yes)
| 20,140,623
| 20,150,326
|
IT-BRISTOL-MYERS SQUIBB COMPANY-21059209
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Hypoglycaemic coma (Recovering / Resolving)
|
GLUCOPHAGE (Suspect), Active: METFORMIN HYDROCHLORIDE, Dosage: 1DF = 40 X 850MG.?INTERRUPTED: 17JUN13.?RE-INTRODUCED, Indication: DIABETES MELLITUS, Action: Drug Withdrawn; NOVOMIX (Suspect), Active: INSULIN ASPART, Dosage: 1DF = 70/30 ^100 U/ML PENFILL IN CARTRIDGE 1 X 3 ML, Indication: DIABETES MELLITUS, Action: Drug Withdrawn; LEVEMIR (Suspect), Active: INSULIN DETEMIR, Dosage: INTERRUPTED: 17JUN13.?1DF = 100 UNITS/ML PENFILL IN CARTRIDGE 1 X 3 ML.?RE-INTRODUCED, Indication: DIABETES MELLITUS, Action: Drug Withdrawn; NOVORAPID (Suspect), Active: INSULIN ASPART, Dosage: INTERRUPTED: 17JUN13.?1DF = 100 U/ML 1 VIAL X 10 ML INJECTION SOLUTION.?RE-INTRODUCED, Indication: DIABETES MELLITUS, Action: Drug Withdrawn
|
['novorapid', 'novomix', 'glucophage', 'levemir']
|
['insulin detemir', 'insulin aspart', 'metformin hydrochloride']
|
['diabetes mellitus']
|
10,253,495
| 2
|
Japan
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,623
| 20,150,326
|
JP-BRISTOL-MYERS SQUIBB COMPANY-21078407
|
Regulatory Authority
|
FDA-Public Use
| 80
|
Year
|
Male
|
Drug-induced liver injury (Recovered / Resolved)
|
ELIQUIS (Suspect), Active: APIXABAN, Indication: THROMBOSIS PROPHYLAXIS, Action: Drug Withdrawn
|
['eliquis']
|
['apixaban']
|
['thrombosis prophylaxis']
|
10,251,066
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,620
| 20,150,326
|
US-TEVA-489521USA
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Female
|
Device expulsion (Recovered / Resolved)
|
PARAGARD T380A (Suspect), Active: COPPER, Indication: CONTRACEPTION, Action: Drug Withdrawn
|
['paragard t380a']
|
['copper']
|
['contraception']
|
10,251,105
| 6
|
Italy
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,620
| 20,150,326
|
IT-EXELIXIS-CABO-14004409
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Male
|
Tumour necrosis (Recovered / Resolved); Asthenia (Recovered / Resolved); Tumour necrosis (Recovered / Resolved); Inflammatory marker increased (Recovering / Resolving); Renal failure (Recovered / Resolved); Lung infection (Recovered / Resolved); Asthenia (Recovering / Resolving); Infection (Recovered / Resolved)
|
COMETRIQ (Suspect), Active: CABOZANTINIB S-MALATE, Dosage: 100 MG, UNK, Action: Dose reduced; COMETRIQ (Suspect), Active: CABOZANTINIB S-MALATE, Dosage: 140 MG, UNK, Indication: MEDULLARY THYROID CANCER, Action: Dose reduced; COMETRIQ (Suspect), Active: CABOZANTINIB S-MALATE, Dosage: 60 MG, UNK, Action: Dose reduced
|
['cometriq']
|
['cabozantinib s-malate']
|
['medullary thyroid cancer']
|
10,251,121
| 2
|
Germany
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,620
| 20,150,326
|
DE-ABBVIE-14P-062-1249638-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Gestational diabetes (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Action: Drug Withdrawn; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn
|
['humira']
|
['adalimumab']
|
['psoriatic arthropathy']
|
10,251,135
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,620
| 20,150,326
|
US-ABBVIE-14K-163-1247975-00
|
Regulatory Authority
|
FDA-Public Use
| 48
|
Year
|
Female
|
Staphylococcal infection (Recovered / Resolved); Bunion operation (Not Recovered / Not Resolved / Ongoing); Foot deformity (Not Recovered / Not Resolved / Ongoing); Burning sensation (Recovering / Resolving)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Action: Drug Withdrawn; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
10,253,549
| 4
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,623
| 20,150,326
|
JP-WATSON-2014-13613
|
Regulatory Authority
|
FDA-Public Use
| 94
|
Year
|
Male
|
Loss of consciousness (Recovered / Resolved); Overdose (Recovering / Resolving)
|
RAPAFLO (Suspect), Active: SILODOSIN, Dosage: 4 MG, BID, Indication: DYSURIA, Action: Drug Withdrawn; RAPAFLO (Suspect), Active: SILODOSIN, Dosage: 28 MG, SINGLE, Action: Drug Withdrawn
|
['rapaflo']
|
['silodosin']
|
['dysuria']
|
10,252,361
| 2
|
Canada
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,140,623
| 20,150,326
|
CA-ABBVIE-14P-028-1249720-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Myocardial infarction (Fatal)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIASIS, Action: Unknown; HUMIRA (Suspect), Active: ADALIMUMAB, Action: Unknown
|
['humira']
|
['adalimumab']
|
['psoriasis']
|
10,250,644
| 3
|
Korea (the Republic of)
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,140,620
| 20,150,326
|
KR-GLAXOSMITHKLINE-B1003937A
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Pneumonia (Fatal)
|
PAZOPANIB (Suspect), Active: PAZOPANIB, Dosage: 600MG PER DAY, Indication: GASTRIC CANCER, Action: Drug Withdrawn; OXALIPLATIN. (Suspect), Active: OXALIPLATIN, Dosage: 140MG PER DAY, Indication: GASTRIC CANCER, Action: Drug Withdrawn; CAPECITABINE (Suspect), Active: CAPECITABINE, Dosage: 650MG TWICE PER DAY, Indication: GASTRIC CANCER, Action: Drug Withdrawn
|
['oxaliplatin.', 'capecitabine', 'pazopanib']
|
['oxaliplatin', 'capecitabine', 'pazopanib']
|
['gastric cancer']
|
10,253,604
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,623
| 20,150,326
|
US-009507513-1406USA005535
|
Regulatory Authority
|
FDA-Public Use
| 32
|
Year
|
Female
|
Dry eye (Recovered / Resolved)
|
CLARITIN-D 12 HOUR (Suspect), Active: LORATADINE\PSEUDOEPHEDRINE SULFATE, Dosage: 5 MG, QD, Indication: HYPERSENSITIVITY, Action: Drug Withdrawn; CLARITIN-D 12 HOUR (Suspect), Active: LORATADINE\PSEUDOEPHEDRINE SULFATE, Dosage: 10 MG, QD, Action: Drug Withdrawn
|
['claritin-d 12 hour']
|
['loratadine\\pseudoephedrine sulfate']
|
['hypersensitivity']
|
10,253,621
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,623
| 20,150,326
|
PHHY2014FR076214
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Coma (Recovered / Resolved); Hypotension (Recovered / Resolved); Bradycardia (Recovered / Resolved)
|
TEMERIT DUO (Suspect), Active: HYDROCHLOROTHIAZIDE\NEBIVOLOL HYDROCHLORIDE, Dosage: 10 DF, QD, Action: Drug Withdrawn; VOLTARENE (Suspect), Active: DICLOFENAC SODIUM, Dosage: 1 DF, QD, Action: Dose reduced; RISPERDAL (Suspect), Active: RISPERIDONE, Dosage: 10 DF (1MG) QD, Action: Drug Withdrawn; VOLTARENE (Suspect), Active: DICLOFENAC SODIUM, Dosage: 10 DF, QD, Action: Dose reduced
|
['voltarene', 'risperdal', 'temerit duo']
|
['hydrochlorothiazide\\nebivolol hydrochloride', 'diclofenac sodium', 'risperidone']
|
[]
|
10,253,630
| 3
|
Australia
|
Report from study
|
Yes
|
Disabling (Yes); Hospitalization (Yes); Other (Yes)
| 20,140,623
| 20,150,326
|
PHHY2014AU076890
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Lymphocyte count decreased (Not Recovered / Not Resolved / Ongoing); Neutrophil count increased (Recovered / Resolved)
|
ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 5 MG, UNK, Action: Dose not changed
|
['aclasta']
|
['zoledronic acid']
|
[]
|
10,251,170
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,620
| 20,150,326
|
US-009507513-1406USA010249
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Male
|
Necrotising herpetic retinopathy (Not Recovered / Not Resolved / Ongoing); Optic neuropathy (Not Recovered / Not Resolved / Ongoing)
|
METHYLPREDNISOLONE SODIUM SUCCINATE. (Suspect), Active: METHYLPREDNISOLONE SODIUM SUCCINATE, Dosage: UNK UNK, QD, Indication: OPTIC NEUROPATHY, Action: Drug Withdrawn; PREDNISONE. (Suspect), Active: PREDNISONE, Dosage: UNK, Indication: OPTIC NEUROPATHY, Action: Unknown
|
['prednisone.', 'methylprednisolone sodium succinate.']
|
['methylprednisolone sodium succinate', 'prednisone']
|
['optic neuropathy']
|
10,252,458
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,623
| 20,150,326
|
US-CELGENEUS-163-21660-14063098
|
Regulatory Authority
|
FDA-Public Use
| 51
|
Year
|
Male
|
Pancreatic carcinoma metastatic (Fatal)
|
ABRAXANE (Suspect), Active: PACLITAXEL, Indication: PANCREATIC CARCINOMA, Action: Unknown
|
['abraxane']
|
['paclitaxel']
|
['pancreatic carcinoma']
|
10,253,632
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,623
| 20,150,326
|
US-JNJFOC-20140611760
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Female
|
Vulvovaginal mycotic infection (Recovered / Resolved); Abnormal loss of weight (Not Recovered / Not Resolved / Ongoing)
|
CYCLOSET (Suspect), Active: BROMOCRIPTINE MESYLATE, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn; INVOKANA (Suspect), Active: CANAGLIFLOZIN, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn
|
['cycloset', 'invokana']
|
['bromocriptine mesylate', 'canagliflozin']
|
['type 2 diabetes mellitus']
|
10,252,533
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,623
| 20,150,326
|
US-TEVA-489971USA
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Device expulsion (Recovered / Resolved)
|
PARAGARD T380A (Suspect), Active: COPPER, Indication: CONTRACEPTION, Action: Drug Withdrawn
|
['paragard t380a']
|
['copper']
|
['contraception']
|
10,250,801
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,620
| 20,150,326
|
US-BAXTER-2014BAX032643
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Ultrafiltration failure (Recovered / Resolved); Abdominal distension (Recovered / Resolved); Abdominal pain (Recovered / Resolved)
|
DIANEAL LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE (Suspect), Active: CALCIUM CHLORIDE\DEXTROSE\MAGNESIUM CHLORIDE\SODIUM CHLORIDE\SODIUM LACTATE, Action: Unknown; DIANEAL LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE (Suspect), Active: CALCIUM CHLORIDE\DEXTROSE\MAGNESIUM CHLORIDE\SODIUM CHLORIDE\SODIUM LACTATE, Indication: PERITONEAL DIALYSIS, Action: Unknown
|
['dianeal low calcium peritoneal dialysis solution with dextrose']
|
['calcium chloride\\dextrose\\magnesium chloride\\sodium chloride\\sodium lactate']
|
['peritoneal dialysis']
|
10,251,471
| 4
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,623
| 20,150,326
|
BR-UCBSA-2014000198
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Female
|
Arthralgia (Not Recovered / Not Resolved / Ongoing)
|
SELOZOK (Suspect), Active: METOPROLOL SUCCINATE, Dosage: 100 MG DAILY, TABLET CONTROLLED RELEASE, Indication: ISCHAEMIC HEART DISEASE PROPHYLAXIS, Action: Unknown; CIMZIA (Suspect), Active: CERTOLIZUMAB PEGOL, Dosage: 200MG/ML, Indication: RHEUMATOID ARTHRITIS, Action: Unknown
|
['selozok', 'cimzia']
|
['metoprolol succinate', 'certolizumab pegol']
|
['ischaemic heart disease prophylaxis', 'rheumatoid arthritis']
|
10,250,851
| 2
|
Taiwan (Province of China)
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,620
| 20,150,326
|
TW-ELI_LILLY_AND_COMPANY-TW201406003148
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Male
|
Stomatitis (Not Recovered / Not Resolved / Ongoing)
|
ALIMTA (Suspect), Active: PEMETREXED DISODIUM, Dosage: 500 MG/M2, UNKNOWN, Indication: NON-SMALL CELL LUNG CANCER STAGE IV, Action: Drug Withdrawn
|
['alimta']
|
['pemetrexed disodium']
|
['non-small cell lung cancer stage iv']
|
10,250,874
| 4
|
Belgium
|
Report from study
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,140,620
| 20,150,326
|
BE-BAYER-2014-077960
|
Regulatory Authority
|
FDA-Public Use
| 69
|
Year
|
Female
|
Sepsis (Recovered / Resolved); Disseminated intravascular coagulation (Recovered / Resolved)
|
REGORAFENIB (Suspect), Active: REGORAFENIB, Dosage: 160 MG, QD ONCE A DAY FOR 3 WEEKS EVERY 4 WEEKS, Indication: COLORECTAL CANCER, Action: Drug Withdrawn; REGORAFENIB (Suspect), Active: REGORAFENIB, Dosage: 120 MG, QD ONCE A DAY FOR 3 WEEKS EVERY 4 WEEKS, Indication: COLORECTAL CANCER, Action: Drug Withdrawn
|
['regorafenib']
|
['regorafenib']
|
['colorectal cancer']
|
10,251,589
| 3
|
Germany
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,623
| 20,150,326
|
DE-AMGEN-DEUSP2014033792
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Spinal pain (Recovered / Resolved); Myalgia (Not Recovered / Not Resolved / Ongoing); Pyrexia (Recovered / Resolved); Pain in extremity (Recovered / Resolved); Abnormal faeces (Not Recovered / Not Resolved / Ongoing)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown
|
['prolia']
|
['denosumab']
|
['product used for unknown indication']
|
10,251,628
| 2
|
Argentina
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,623
| 20,150,326
|
AR-AMGEN INC.-ARGSP2014046733
|
Regulatory Authority
|
FDA-Public Use
| 45
|
Year
|
Female
|
Meniscus injury (Not Recovered / Not Resolved / Ongoing); Limb discomfort (Recovering / Resolving)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, WEEKLY, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,274,763
| 1
|
Argentina
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
AR-ABBVIE-14P-007-1254254-00
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Left ventricular dysfunction (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
10,274,911
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,702
| 20,150,326
|
US-AMGEN INC.-USASP2014048534
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Dry skin (Not Recovered / Not Resolved / Ongoing); Weight increased (Not Recovered / Not Resolved / Ongoing); Peripheral swelling (Not Recovered / Not Resolved / Ongoing); Pruritus (Not Recovered / Not Resolved / Ongoing); Drug administration error (Recovered / Resolved); Injection site pain (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: PSORIASIS, Action: Drug Withdrawn
|
['enbrel']
|
['etanercept']
|
['psoriasis']
|
10,274,917
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-AMGEN INC.-USASP2014049185
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Male
|
Dementia (Not Recovered / Not Resolved / Ongoing); Pain in extremity (Recovered / Resolved); Dementia Alzheimer^s type (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,274,921
| 2
|
France
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,702
| 20,150,326
|
FR-BRISTOL-MYERS SQUIBB COMPANY-21087663
|
Regulatory Authority
|
FDA-Public Use
| 15
|
Year
|
Female
|
Extrapyramidal disorder (Recovered / Resolved)
|
ABILIFY DISCMELT (Suspect), Active: ARIPIPRAZOLE, Action: Unknown
|
['abilify discmelt']
|
['aripiprazole']
|
[]
|
10,275,161
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063960
|
Regulatory Authority
|
FDA-Public Use
| 41
|
Year
|
Female
|
Multiple sclerosis relapse (Recovered / Resolved); Hysterectomy (Recovered / Resolved)
|
TYSABRI (Suspect), Active: NATALIZUMAB, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['tysabri']
|
['natalizumab']
|
['multiple sclerosis']
|
10,275,170
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063287
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Male
|
Cardiac failure (Fatal)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,173
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063344
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Myocardial infarction (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: RELAPSING-REMITTING MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['avonex']
|
['interferon beta-1a']
|
['relapsing-remitting multiple sclerosis']
|
10,275,179
| 1
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063389
|
Regulatory Authority
|
FDA-Public Use
| 41
|
Year
|
Female
|
Gallbladder operation (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,283
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN INC.-USASP2014049017
|
Regulatory Authority
|
FDA-Public Use
| 50
|
Year
|
Female
|
Injection site reaction (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,275,292
| 1
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
FR-ROCHE-1426239
|
Regulatory Authority
|
FDA-Public Use
| 29
|
Year
|
Female
|
Hepatocellular injury (Recovered / Resolved); Vomiting (Recovered / Resolved); Transaminases increased (Recovered / Resolved)
|
RIFINAH (Suspect), Active: ISONIAZID\RIFAMPIN, Dosage: 300MG/150MG, Indication: ANTIBIOTIC PROPHYLAXIS, Action: Drug Withdrawn; BACTRIM (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn; MABTHERA (Suspect), Active: RITUXIMAB, Indication: ANTISYNTHETASE SYNDROME, Action: Unknown; ACTONEL (Suspect), Active: RISEDRONATE SODIUM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn; MABTHERA (Suspect), Active: RITUXIMAB, Action: Unknown; INEXIUM (Suspect), Active: ESOMEPRAZOLE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn
|
['inexium', 'mabthera', 'bactrim', 'actonel', 'rifinah']
|
['isoniazid\\rifampin', 'sulfamethoxazole\\trimethoprim', 'risedronate sodium', 'rituximab', 'esomeprazole']
|
['antibiotic prophylaxis', 'antisynthetase syndrome', 'product used for unknown indication']
|
10,275,579
| 1
|
France
|
Spontaneous
|
Yes
|
Life-threatening (Yes)
| 20,140,703
| 20,150,326
|
FR-JNJFOC-20140700152
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Male
|
Ischaemic stroke (Recovering / Resolving)
|
PLAVIX (Suspect), Active: CLOPIDOGREL BISULFATE, Indication: CORONARY ARTERY DISEASE, Action: Drug Withdrawn; XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn; CORDARONE (Suspect), Active: AMIODARONE HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn
|
['cordarone', 'plavix', 'xarelto']
|
['clopidogrel bisulfate', 'rivaroxaban', 'amiodarone hydrochloride']
|
['coronary artery disease', 'atrial fibrillation', 'product used for unknown indication']
|
10,275,591
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,703
| 20,150,326
|
US-JNJFOC-20140619707
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Haematoma (Recovering / Resolving)
|
XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn; XARELTO (Suspect), Active: RIVAROXABAN, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Drug Withdrawn
|
['xarelto']
|
['rivaroxaban']
|
['cerebrovascular accident prophylaxis', 'atrial fibrillation']
|
10,274,927
| 1
|
Turkey
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
TR-US-EMD SERONO, INC.-7302075
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Asthenia (Not Recovered / Not Resolved / Ongoing); Angina pectoris (Recovered / Resolved); Fatigue (Not Recovered / Not Resolved / Ongoing); Back pain (Recovered / Resolved); Pruritus generalised (Not Recovered / Not Resolved / Ongoing)
|
REBIF (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Unknown; APIKOBAL (Suspect), Active: CYANOCOBALAMIN\PYRIDOXINE HYDROCHLORIDE\THIAMINE, Indication: VITAMIN B COMPLEX DEFICIENCY, Action: Unknown; SERTRALINE HYDROCHLORIDE. (Suspect), Active: SERTRALINE HYDROCHLORIDE, Indication: DEPRESSION, Action: Unknown
|
['apikobal', 'sertraline hydrochloride.', 'rebif']
|
['cyanocobalamin\\pyridoxine hydrochloride\\thiamine', 'sertraline hydrochloride', 'interferon beta-1a']
|
['vitamin b complex deficiency', 'depression', 'multiple sclerosis']
|
10,274,938
| 2
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
PHHY2014BR080337
|
Regulatory Authority
|
FDA-Public Use
| 69
|
Year
|
Male
|
Nausea (Recovered / Resolved); Malaise (Recovered / Resolved); Blood pressure increased (Not Recovered / Not Resolved / Ongoing); Dizziness (Recovered / Resolved); Vomiting (Recovered / Resolved)
|
CANDESARTAN CILEXETIL. (Suspect), Active: CANDESARTAN CILEXETIL, Dosage: 8 MG, UNK, Indication: HYPERTENSION, Action: Unknown; CANDESARTAN CILEXETIL. (Suspect), Active: CANDESARTAN CILEXETIL, Dosage: 16 MG, UNK, Action: Unknown
|
['candesartan cilexetil.']
|
['candesartan cilexetil']
|
['hypertension']
|
10,275,181
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063432
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Female
|
Surgery (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,189
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI064498
|
Regulatory Authority
|
FDA-Public Use
| 42
|
Year
|
Male
|
Neck surgery (Recovered / Resolved); Musculoskeletal disorder (Recovered / Resolved); Back pain (Not Recovered / Not Resolved / Ongoing); Diplegia (Recovered / Resolved); Blindness transient (Recovered / Resolved); Coordination abnormal (Recovered / Resolved); Road traffic accident (Recovered / Resolved); Middle insomnia (Recovered / Resolved); Multiple sclerosis relapse (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,299
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN INC.-USASP2014049475
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Female
|
Tooth extraction (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 25 MG, 2 TIMES/WK, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn
|
['enbrel']
|
['etanercept']
|
['psoriatic arthropathy']
|
10,275,304
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Disabling (Yes)
| 20,140,703
| 20,150,326
|
US-AMGEN-USASP2014048955
|
Regulatory Authority
|
FDA-Public Use
| 64
|
Year
|
Female
|
Abdominal discomfort (Not Recovered / Not Resolved / Ongoing)
|
SENSIPAR (Suspect), Active: CINACALCET HYDROCHLORIDE, Dosage: 60 MG, QD, Indication: HYPERPARATHYROIDISM SECONDARY, Action: Drug Withdrawn
|
['sensipar']
|
['cinacalcet hydrochloride']
|
['hyperparathyroidism secondary']
|
10,275,196
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063074
|
Regulatory Authority
|
FDA-Public Use
| 38
|
Year
|
Female
|
Incorrect dose administered (Not Recovered / Not Resolved / Ongoing)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,202
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063663
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Blindness (Not Recovered / Not Resolved / Ongoing)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
10,275,321
| 1
|
Denmark
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
DK-009507513-1406DNK014135
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Impaired healing (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing); Oral cavity fistula (Not Recovered / Not Resolved / Ongoing); Tooth extraction (Recovered / Resolved); Osteonecrosis of jaw (Not Recovered / Not Resolved / Ongoing); Swelling (Not Recovered / Not Resolved / Ongoing)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: STRENGTH 60 MG/ML, Indication: OSTEOPOROSIS, Action: Unknown; BONVIVA (Suspect), Active: IBANDRONATE SODIUM, Dosage: STRENGTH 150 MG, MONTHLY, Indication: OSTEOPOROSIS, Action: Unknown; FOSAMAX (Suspect), Active: ALENDRONATE SODIUM, Dosage: 70 MG, QD, STRENGTH 70 MG, Indication: OSTEOPOROSIS, Action: Unknown
|
['bonviva', 'fosamax', 'prolia']
|
['alendronate sodium', 'denosumab', 'ibandronate sodium']
|
['osteoporosis']
|
10,275,611
| 1
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
FR-JNJFOC-20140700136
|
Regulatory Authority
|
FDA-Public Use
| 86
|
Year
|
Female
|
Gamma-glutamyltransferase increased (Recovering / Resolving); Hepatitis (Recovering / Resolving); Cardiac failure (Recovering / Resolving); Asthenia (Recovering / Resolving)
|
XARELTO (Suspect), Active: RIVAROXABAN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn
|
['xarelto']
|
['rivaroxaban']
|
['product used for unknown indication']
|
10,275,336
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093631
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Male
|
Death (Fatal)
|
ARANESP (Suspect), Active: DARBEPOETIN ALFA, Dosage: 300 MUG, QWK, Indication: MYELODYSPLASTIC SYNDROME, Action: Unknown; ARANESP (Suspect), Active: DARBEPOETIN ALFA, Indication: ANAEMIA, Action: Unknown
|
['aranesp']
|
['darbepoetin alfa']
|
['anaemia', 'myelodysplastic syndrome']
|
10,275,242
| 3
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI062234
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Female
|
Malaise (Recovered / Resolved)
|
TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['tecfidera']
|
['dimethyl fumarate']
|
['multiple sclerosis']
|
10,275,363
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2014049783
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Male
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 120 MG, Q4WK, Indication: METASTASES TO BONE, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['metastases to bone']
|
10,275,003
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-GILEAD-2014-0107156
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Overdose (Recovered / Resolved)
|
SOVALDI (Suspect), Active: SOFOSBUVIR, Dosage: 1 DF, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; SOVALDI (Suspect), Active: SOFOSBUVIR, Dosage: 2 DF, QD, Action: Dose not changed
|
['sovaldi']
|
['sofosbuvir']
|
['product used for unknown indication']
|
10,275,256
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
US-BIOGENIDEC-2014BI063235
|
Regulatory Authority
|
FDA-Public Use
| 45
|
Year
|
Female
|
Hypersensitivity (Not Recovered / Not Resolved / Ongoing)
|
TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Indication: RELAPSING-REMITTING MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['tecfidera']
|
['dimethyl fumarate']
|
['relapsing-remitting multiple sclerosis']
|
10,275,371
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093881
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Death (Fatal)
|
ARANESP (Suspect), Active: DARBEPOETIN ALFA, Dosage: 150 MUG, QWK, Indication: ANAEMIA, Action: Unknown
|
['aranesp']
|
['darbepoetin alfa']
|
['anaemia']
|
10,275,383
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-009507513-1406USA005176
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Female
|
Somnolence (Recovered / Resolved)
|
CLARITIN-D 12 HOUR (Suspect), Active: LORATADINE\PSEUDOEPHEDRINE SULFATE, Dosage: 5 MG, BID, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn
|
['claritin-d 12 hour']
|
['loratadine\\pseudoephedrine sulfate']
|
['product used for unknown indication']
|
10,275,029
| 2
|
Poland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
PL-ROCHE-1428746
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Chills (Recovered / Resolved); Blood pressure increased (Recovered / Resolved)
|
HERCEPTIN (Suspect), Active: TRASTUZUMAB, Dosage: SECOND INFUSION THAT WAS WAS COMPLETED ON THE SAME DAY WITHOUT AND ADVERSE EVENTS, Action: Drug Withdrawn; HERCEPTIN (Suspect), Active: TRASTUZUMAB, Dosage: FREQUENCY: 3 WEEKS, Indication: BREAST CANCER, Action: Drug Withdrawn
|
['herceptin']
|
['trastuzumab']
|
['breast cancer']
|
10,275,277
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN-USASP2014044457
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Tremor (Recovered / Resolved); Arthralgia (Not Recovered / Not Resolved / Ongoing); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Blood pressure abnormal (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,275,402
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093558
|
Regulatory Authority
|
FDA-Public Use
| 80
|
Year
|
Male
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 1.7 ML, Q4WK, Indication: PROPHYLAXIS, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['prophylaxis']
|
10,274,660
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,702
| 20,150,326
|
US-009507513-1406USA003107
|
Regulatory Authority
|
FDA-Public Use
| 43
|
Year
|
Male
|
Vomiting (Recovered / Resolved)
|
MIRALAX (Suspect), Active: POLYETHYLENE GLYCOL 3350, Dosage: 17 G, ONCE, Indication: CONSTIPATION, Action: Drug Withdrawn
|
['miralax']
|
['polyethylene glycol 3350']
|
['constipation']
|
10,274,784
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,702
| 20,150,326
|
US-GILEAD-2014-0106813
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Myalgia (Recovered / Resolved)
|
SOVALDI (Suspect), Active: SOFOSBUVIR, Dosage: 400 MG, QD, Indication: CHRONIC HEPATITIS C, Action: Dose not changed
|
['sovaldi']
|
['sofosbuvir']
|
['chronic hepatitis c']
|
10,275,046
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
FR-MERCK-1406FRA012025
|
Regulatory Authority
|
FDA-Public Use
| 1
|
Year
|
Male
|
Incorrect dose administered (Recovered / Resolved); Somnolence (Recovered / Resolved)
|
AERIUS (Suspect), Active: DESLORATADINE, Dosage: 5 MG, QD, Action: Drug Withdrawn
|
['aerius']
|
['desloratadine']
|
[]
|
10,275,058
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN-USASP2014048934
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Injection site swelling (Not Recovered / Not Resolved / Ongoing); Injection site warmth (Not Recovered / Not Resolved / Ongoing); Weight increased (Not Recovered / Not Resolved / Ongoing); Injection site erythema (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,275,059
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
US-AMGEN INC.-USASP2014048864
|
Regulatory Authority
|
FDA-Public Use
| 32
|
Year
|
Female
|
Abnormal behaviour (Not Recovered / Not Resolved / Ongoing); Epistaxis (Not Recovered / Not Resolved / Ongoing); Mental disorder (Not Recovered / Not Resolved / Ongoing); Amnesia (Not Recovered / Not Resolved / Ongoing); Delusion of grandeur (Not Recovered / Not Resolved / Ongoing); Confusional state (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: UNK, Indication: ANKYLOSING SPONDYLITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['ankylosing spondylitis']
|
10,274,674
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,140,702
| 20,150,326
|
US-BAXTER-2014BAX033948
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Prostate cancer (Recovered / Resolved)
|
DIANEAL LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE (Suspect), Active: CALCIUM CHLORIDE\DEXTROSE\MAGNESIUM CHLORIDE\SODIUM CHLORIDE\SODIUM LACTATE, Indication: PERITONEAL DIALYSIS, Action: Dose not changed
|
['dianeal low calcium peritoneal dialysis solution with dextrose']
|
['calcium chloride\\dextrose\\magnesium chloride\\sodium chloride\\sodium lactate']
|
['peritoneal dialysis']
|
10,274,676
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,702
| 20,150,326
|
US-RECKITT BENCKISER PHARMACEUTICAL, INC-RB-63936-2014
|
Regulatory Authority
|
FDA-Public Use
| 40
|
Year
|
Male
|
Type 2 diabetes mellitus (Not Recovered / Not Resolved / Ongoing); Joint swelling (Not Recovered / Not Resolved / Ongoing); Concussion (Not Recovered / Not Resolved / Ongoing); Road traffic accident (Recovered / Resolved); Joint dislocation (Not Recovered / Not Resolved / Ongoing); Arthropathy (Recovered / Resolved); Ligament rupture (Recovering / Resolving); Hypertension (Not Recovered / Not Resolved / Ongoing); Brain injury (Not Recovered / Not Resolved / Ongoing); Anxiety (Not Recovered / Not Resolved / Ongoing); Amnesia (Not Recovered / Not Resolved / Ongoing); Wrong technique in drug usage process (Not Recovered / Not Resolved / Ongoing)
|
SUBUTEX (Suspect), Active: BUPRENORPHINE HYDROCHLORIDE, Dosage: 1/2 TABLET, USING VARIOUS DOSES, Indication: DRUG DEPENDENCE, Action: Unknown; SUBOXONE (Suspect), Active: BUPRENORPHINE HYDROCHLORIDE\NALOXONE HYDROCHLORIDE, Dosage: SUBOXONE FILM; 1/2 STRIP TWICE A DAY, Indication: DRUG DEPENDENCE, Action: Drug Withdrawn; SUBOXONE (Suspect), Active: BUPRENORPHINE HYDROCHLORIDE\NALOXONE HYDROCHLORIDE, Dosage: 1/2 TABLET TWICE DAILY, Indication: DRUG DEPENDENCE, Action: Drug Withdrawn
|
['suboxone', 'subutex']
|
['buprenorphine hydrochloride\\naloxone hydrochloride', 'buprenorphine hydrochloride']
|
['drug dependence']
|
10,275,440
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
US-AMGEN INC.-USASP2014048860
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Psoriatic arthropathy (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Indication: PSORIASIS, Action: Unknown; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, 2 TIMES/WK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown
|
['enbrel']
|
['etanercept']
|
['psoriatic arthropathy', 'psoriasis']
|
10,274,788
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,140,702
| 20,150,326
|
US-GILEAD-2014-0107170
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Cardiac arrest (Fatal)
|
SOVALDI (Suspect), Active: SOFOSBUVIR, Dosage: 400 MG, QD, Indication: HEPATITIS C, Action: Unknown; SIMEPREVIR (Suspect), Active: SIMEPREVIR, Dosage: 150 MG, QD, Indication: HEPATITIS C, Action: Unknown
|
['sovaldi', 'simeprevir']
|
['sofosbuvir', 'simeprevir']
|
['hepatitis c']
|
10,275,070
| 2
|
China
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
CN-ACCORD-024513
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Female
|
Pneumocystis jirovecii pneumonia (Fatal)
|
PREDNISONE. (Suspect), Active: PREDNISONE, Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown; METHYLPREDNISOLONE (Suspect), Active: METHYLPREDNISOLONE, Dosage: PULSE THERAPY: 1G/DAY X 3 DAYS, Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown; MYCOPHENOLIC ACID (Suspect), Active: MYCOPHENOLIC ACID, Dosage: RECEIVED FROM 3 MONTHS., Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown
|
['methylprednisolone', 'prednisone.', 'mycophenolic acid']
|
['methylprednisolone', 'prednisone', 'mycophenolic acid']
|
['microscopic polyangiitis']
|
10,275,071
| 2
|
China
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
CN-ACCORD-024514
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Male
|
Pneumocystis jirovecii pneumonia (Recovering / Resolving); Lymphopenia (Recovering / Resolving)
|
METHYLPREDNISOLONE (Suspect), Active: METHYLPREDNISOLONE, Dosage: PULSE THERAPY: 1G/DAY X 3 DAYS, Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown; PREDNISONE. (Suspect), Active: PREDNISONE, Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown; MYCOPHENOLIC ACID (Suspect), Active: MYCOPHENOLIC ACID, Indication: MICROSCOPIC POLYANGIITIS, Action: Unknown
|
['methylprednisolone', 'prednisone.', 'mycophenolic acid']
|
['methylprednisolone', 'prednisone', 'mycophenolic acid']
|
['microscopic polyangiitis']
|
10,275,076
| 2
|
China
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
CN-ACCORD-024523
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Cytomegalovirus infection (Recovering / Resolving); Epstein-Barr virus infection (Recovering / Resolving); Pneumocystis jirovecii pneumonia (Recovering / Resolving); Lymphopenia (Recovering / Resolving)
|
MYCOPHENOLIC ACID (Suspect), Active: MYCOPHENOLIC ACID, Indication: SYSTEMIC LUPUS ERYTHEMATOSUS, Action: Unknown; PREDNISONE. (Suspect), Active: PREDNISONE, Indication: SYSTEMIC LUPUS ERYTHEMATOSUS, Action: Unknown
|
['prednisone.', 'mycophenolic acid']
|
['prednisone', 'mycophenolic acid']
|
['systemic lupus erythematosus']
|
10,275,442
| 1
|
Brazil
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,140,703
| 20,150,326
|
BR-BAYER-2014-095922
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Male
|
Ascites (Not Recovered / Not Resolved / Ongoing); Weight decreased (Not Recovered / Not Resolved / Ongoing); Hepatic cancer (Fatal)
|
NEXAVAR (Suspect), Active: SORAFENIB, Dosage: 400 MG, BID, Indication: HEPATIC CANCER, Action: Unknown
|
['nexavar']
|
['sorafenib']
|
['hepatic cancer']
|
10,275,446
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093747
|
Regulatory Authority
|
FDA-Public Use
| 45
|
Year
|
Female
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 1.7 ML, Q4WK, Indication: PROPHYLAXIS, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['prophylaxis']
|
10,274,813
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,140,702
| 20,150,326
|
US-ACORDA-ACO_37146_2013
|
Regulatory Authority
|
FDA-Public Use
| 64
|
Year
|
Female
|
Myocardial infarction (Recovering / Resolving)
|
AMPYRA (Suspect), Active: DALFAMPRIDINE, Indication: GAIT DISTURBANCE, Action: Drug Withdrawn; AMPYRA (Suspect), Active: DALFAMPRIDINE, Dosage: 10 MG, Q 12 HRS, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn
|
['ampyra']
|
['dalfampridine']
|
['gait disturbance', 'multiple sclerosis']
|
10,274,818
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-ALLERGAN-1414402US
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Chest discomfort (Recovered / Resolved); Muscle tightness (Not Recovered / Not Resolved / Ongoing); Chest pain (Recovered / Resolved); Chest pain (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Dysphagia (Not Recovered / Not Resolved / Ongoing)
|
BOTOX COSMETIC (Suspect), Active: ONABOTULINUMTOXINA, Dosage: 20 UNITS, SINGLE, Action: Unknown; BOTOX COSMETIC (Suspect), Active: ONABOTULINUMTOXINA, Dosage: 10 UNITS, SINGLE, Indication: SKIN WRINKLING, Action: Unknown; BOTOX COSMETIC (Suspect), Active: ONABOTULINUMTOXINA, Dosage: 20 UNITS, SINGLE, Indication: SKIN WRINKLING, Action: Unknown; BOTOX COSMETIC (Suspect), Active: ONABOTULINUMTOXINA, Dosage: UNK, Action: Unknown
|
['botox cosmetic']
|
['onabotulinumtoxina']
|
['skin wrinkling']
|
10,275,077
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN-USASP2014036784
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Male
|
Nausea (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: PSORIASIS, Action: Dose not changed; INDOMETHACIN /00003801/ (Suspect), Active: INDOMETHACIN, Dosage: 50 MG, AS NECESSARY, Indication: ARTHRALGIA, Action: Unknown; ENBREL (Suspect), Active: ETANERCEPT, Indication: PSORIATIC ARTHROPATHY, Action: Dose not changed
|
['indomethacin /00003801/', 'enbrel']
|
['etanercept', 'indomethacin']
|
['arthralgia', 'psoriatic arthropathy', 'psoriasis']
|
10,275,081
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093391
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 1.7 ML, Q4WK, Indication: PROPHYLAXIS, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['prophylaxis']
|
10,275,092
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-009507513-1406USA013557
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Device breakage (Recovered / Resolved)
|
NEXPLANON (Suspect), Active: ETONOGESTREL, Dosage: 68 MG, ONCE EVERY 3 YEARS, Action: Dose not changed
|
['nexplanon']
|
['etonogestrel']
|
[]
|
10,275,464
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-SHIRE-US201403628
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
No adverse event (Not Recovered / Not Resolved / Ongoing); Off label use (Not Recovered / Not Resolved / Ongoing)
|
PENTASA (Suspect), Active: MESALAMINE, Dosage: 250 MG, UNKNOWN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed
|
['pentasa']
|
['mesalamine']
|
['product used for unknown indication']
|
10,275,467
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-SHIRE-US201403577
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Arthropod bite (Not Recovered / Not Resolved / Ongoing); Cough (Not Recovered / Not Resolved / Ongoing); Sneezing (Not Recovered / Not Resolved / Ongoing); Rhinorrhoea (Recovered / Resolved); Inappropriate schedule of drug administration (Not Recovered / Not Resolved / Ongoing); Pruritus (Not Recovered / Not Resolved / Ongoing)
|
LIALDA (Suspect), Active: MESALAMINE, Dosage: 2.4 G (TWO 1.2 G TABLETS), 2X/DAY:BID, Indication: COLITIS ULCERATIVE, Action: Dose not changed
|
['lialda']
|
['mesalamine']
|
['colitis ulcerative']
|
10,274,824
| 3
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes)
| 20,140,702
| 20,150,326
|
JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-27207NB
|
Regulatory Authority
|
FDA-Public Use
| 79
|
Year
|
Male
|
Haemorrhoidal haemorrhage (Not Recovered / Not Resolved / Ongoing); Iron deficiency anaemia (Not Recovered / Not Resolved / Ongoing)
|
PRAZAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Dosage: 220 MG, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn
|
['prazaxa']
|
['dabigatran etexilate mesylate']
|
['atrial fibrillation']
|
10,274,827
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,702
| 20,150,326
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-30025BP
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Death (Fatal)
|
PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Dosage: 300 MG, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Unknown; WARFARIN (Suspect), Active: WARFARIN, Dosage: NOT REPORTED, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Indication: ATRIAL FIBRILLATION, Action: Unknown
|
['pradaxa', 'warfarin']
|
['dabigatran etexilate mesylate', 'warfarin']
|
['cerebrovascular accident prophylaxis', 'atrial fibrillation', 'product used for unknown indication']
|
10,275,096
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN INC.-NLDSP2013093413
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Male
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 1.7 ML, Q4WK, Indication: METASTASES TO BONE, Action: Unknown; XGEVA (Suspect), Active: DENOSUMAB, Indication: PROPHYLAXIS, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['prophylaxis', 'metastases to bone']
|
10,275,097
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,703
| 20,150,326
|
NL-AMGEN-NLDSP2013093821
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Female
|
Death (Fatal)
|
XGEVA (Suspect), Active: DENOSUMAB, Dosage: 1.7 ML, Q4WK, Indication: PROPHYLAXIS, Action: Unknown
|
['xgeva']
|
['denosumab']
|
['prophylaxis']
|
10,275,102
| 3
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,140,703
| 20,150,326
|
DE-ROCHE-1296190
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Female
|
Metabolic acidosis (Recovered / Resolved); Dyspnoea (Recovered / Resolved)
|
PACLITAXEL. (Suspect), Active: PACLITAXEL, Indication: OVARIAN CANCER, Action: Drug Withdrawn; PACLITAXEL. (Suspect), Active: PACLITAXEL, Indication: BREAST CANCER, Action: Drug Withdrawn; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Action: Drug Withdrawn; BEVACIZUMAB (Suspect), Active: BEVACIZUMAB, Dosage: LAST GIVEN DOSAGE OF BEVACIZUMAB WAS GIVEN ON 28-OCT-2013, Indication: OVARIAN CANCER, Action: Dose not changed; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Indication: OVARIAN CANCER, Action: Drug Withdrawn; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Indication: BREAST CANCER, Action: Drug Withdrawn; BEVACIZUMAB (Suspect), Active: BEVACIZUMAB, Indication: BREAST CANCER, Action: Dose not changed
|
['carboplatin.', 'paclitaxel.', 'bevacizumab']
|
['carboplatin', 'bevacizumab', 'paclitaxel']
|
['ovarian cancer', 'breast cancer']
|
10,274,707
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,702
| 20,150,326
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-28884BP
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Heart valve replacement (Not Recovered / Not Resolved / Ongoing)
|
PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Dosage: 150 MG, Indication: ATRIAL FIBRILLATION, Action: Dose not changed
|
['pradaxa']
|
['dabigatran etexilate mesylate']
|
['atrial fibrillation']
|
10,274,710
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,702
| 20,150,326
|
US-JNJFOC-20140615535
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Female
|
Depressed level of consciousness (Recovered / Resolved)
|
INVEGA SUSTENNA (Suspect), Active: PALIPERIDONE PALMITATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed
|
['invega sustenna']
|
['paliperidone palmitate']
|
['product used for unknown indication']
|
10,274,711
| 1
|
Argentina
|
Report from study
|
Yes
|
Disabling (Yes)
| 20,140,702
| 20,150,326
|
AR-ABBVIE-14P-007-1254865-00
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Female
|
Chondropathy (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
10,275,114
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-29192BP
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Pyrexia (Recovered / Resolved); Anaemia (Not Recovered / Not Resolved / Ongoing)
|
SPIRIVA (Suspect), Active: TIOTROPIUM BROMIDE MONOHYDRATE, Dosage: 18 MCG, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed; COMBIVENT (Suspect), Active: ALBUTEROL SULFATE\IPRATROPIUM BROMIDE, Dosage: STRENGTH: 20 MCG / 100 MCG; DAILY DOSE: 80 MCG/400 MCG, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed
|
['spiriva', 'combivent']
|
['albuterol sulfate\\ipratropium bromide', 'tiotropium bromide monohydrate']
|
['chronic obstructive pulmonary disease']
|
10,275,518
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN-USASP2014048952
|
Regulatory Authority
|
FDA-Public Use
| 43
|
Year
|
Female
|
Injection site pain (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,275,127
| 1
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Disabling (Yes); Hospitalization (Yes); Other (Yes)
| 20,140,703
| 20,150,326
|
GB-DRREDDYS-GER/UKI/14/0041456
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Female
|
Immobile (Recovering / Resolving); Eating disorder (Recovering / Resolving); Somnolence (Recovering / Resolving); Hepatic function abnormal (Recovering / Resolving)
|
LEVOFLOXACIN (Suspect), Active: LEVOFLOXACIN, Indication: PNEUMONIA, Action: Drug Withdrawn; SIMVASTATIN. (Suspect), Active: SIMVASTATIN, Indication: HYPERCHOLESTEROLAEMIA, Action: Drug Withdrawn
|
['simvastatin.', 'levofloxacin']
|
['simvastatin', 'levofloxacin']
|
['hypercholesterolaemia', 'pneumonia']
|
10,274,738
| 1
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-ABBVIE-14P-163-1254567-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Muscle spasms (Not Recovered / Not Resolved / Ongoing); Arthralgia (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
10,274,857
| 1
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-ALEXION PHARMACEUTICALS INC.-A201304962
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Male
|
Transfusion (Recovered / Resolved)
|
SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: 1200 MG, UNK, Indication: PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA, Action: Dose not changed
|
['soliris']
|
['eculizumab']
|
['paroxysmal nocturnal haemoglobinuria']
|
10,274,875
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-AMGEN INC.-USASP2014049100
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Female
|
Crohn^s disease (Recovered / Resolved); Neck pain (Not Recovered / Not Resolved / Ongoing); Influenza (Recovered / Resolved); Local swelling (Not Recovered / Not Resolved / Ongoing); Ill-defined disorder (Not Recovered / Not Resolved / Ongoing); Headache (Recovered / Resolved); Adverse event (Recovered / Resolved); Bone pain (Not Recovered / Not Resolved / Ongoing); Inflammatory bowel disease (Recovered / Resolved); Malaise (Recovered / Resolved); Finger deformity (Not Recovered / Not Resolved / Ongoing); Bone swelling (Not Recovered / Not Resolved / Ongoing); Weight decreased (Recovered / Resolved); Nausea (Recovered / Resolved)
|
CIMZIA (Suspect), Active: CERTOLIZUMAB PEGOL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; ENBREL (Suspect), Active: ETANERCEPT, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn
|
['enbrel', 'humira', 'cimzia']
|
['etanercept', 'certolizumab pegol', 'adalimumab']
|
['psoriatic arthropathy', 'product used for unknown indication']
|
10,275,133
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,140,703
| 20,150,326
|
US-AMGEN INC.-USASP2014049106
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Female
|
Injection site bruising (Not Recovered / Not Resolved / Ongoing); Injection site erythema (Not Recovered / Not Resolved / Ongoing); Injection site rash (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
10,274,748
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,140,702
| 20,150,326
|
US-ABBVIE-11P-163-0699938-00
|
Regulatory Authority
|
FDA-Public Use
| 50
|
Year
|
Female
|
Psoriasis (Not Recovered / Not Resolved / Ongoing); Skin fissures (Not Recovered / Not Resolved / Ongoing); Blood creatinine increased (Recovering / Resolving); Skin haemorrhage (Not Recovered / Not Resolved / Ongoing); Wound haemorrhage (Not Recovered / Not Resolved / Ongoing); Wound complication (Not Recovered / Not Resolved / Ongoing); Rash erythematous (Recovering / Resolving); Urticaria (Not Recovered / Not Resolved / Ongoing); Rash vesicular (Not Recovered / Not Resolved / Ongoing); Psoriasis (Not Recovered / Not Resolved / Ongoing); Drug effect decreased (Not Recovered / Not Resolved / Ongoing); Pruritus (Recovering / Resolving); Gallbladder operation (Recovering / Resolving); Skin exfoliation (Not Recovered / Not Resolved / Ongoing)
|
CYCLOSPORINE. (Suspect), Active: CYCLOSPORINE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; HUMIRA (Suspect), Active: ADALIMUMAB, Action: Drug Withdrawn; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIASIS, Action: Drug Withdrawn
|
['cyclosporine.', 'humira']
|
['cyclosporine', 'adalimumab']
|
['psoriasis', 'product used for unknown indication']
|
10,274,885
| 1
|
Netherlands
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,140,702
| 20,150,326
|
NL-AMGEN INC.-NLDSP2011071722
|
Regulatory Authority
|
FDA-Public Use
| 96
|
Year
|
Male
|
Death (Fatal)
|
ARANESP (Suspect), Active: DARBEPOETIN ALFA, Dosage: 100 MUG, QWK, Indication: NEPHROGENIC ANAEMIA, Action: Unknown
|
['aranesp']
|
['darbepoetin alfa']
|
['nephrogenic anaemia']
|
10,275,149
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,140,703
| 20,150,326
|
US-BEH-2014043376
|
Regulatory Authority
|
FDA-Public Use
| 24
|
Year
|
Female
|
Haematocrit decreased (Recovered / Resolved); Reticulocyte count increased (Recovered / Resolved); Coombs direct test positive (Recovered / Resolved); Haemoglobin decreased (Recovered / Resolved); Haptoglobin decreased (Recovered / Resolved); Spherocytic anaemia (Recovered / Resolved); Haemolytic anaemia (Recovered / Resolved); Chromaturia (Recovered / Resolved)
|
INTRAVENOUS IMMUNOGLOBULIN (Suspect), Active: HUMAN IMMUNOGLOBULIN G, Indication: MYASTHENIA GRAVIS, Action: Unknown
|
['intravenous immunoglobulin']
|
['human immunoglobulin g']
|
['myasthenia gravis']
|
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