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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
14,645,897
| 2
|
France
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-023828
|
Regulatory Authority
|
FDA-Public Use
| 75
|
Year
|
Male
|
Central nervous system lesion (Recovered / Resolved)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 200 MG, Q2WK, Indication: LUNG NEOPLASM MALIGNANT, Action: Dose not changed
|
['nivolumab']
|
['nivolumab']
|
['lung neoplasm malignant']
|
14,648,462
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,316
| 20,180,711
|
US-PFIZER INC-2018104655
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Female
|
Atrial fibrillation (Not Recovered / Not Resolved / Ongoing)
|
PREMARIN (Suspect), Active: ESTROGENS, CONJUGATED, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['premarin']
|
['estrogens, conjugated']
|
[]
|
14,651,224
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
GB-GILEAD-2018-0327618
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Female
|
Tinnitus (Not Recovered / Not Resolved / Ongoing); Neck pain (Not Recovered / Not Resolved / Ongoing); Headache (Not Recovered / Not Resolved / Ongoing); Dysgeusia (Not Recovered / Not Resolved / Ongoing); Discomfort (Not Recovered / Not Resolved / Ongoing)
|
TICAGRELOR. (Suspect), Active: TICAGRELOR, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No; RANOLAZINE. (Suspect), Active: RANOLAZINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['ticagrelor.', 'ranolazine.']
|
['ticagrelor', 'ranolazine']
|
['product used for unknown indication']
|
14,638,033
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
US-BIOGEN-2018BI00531975
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Male
|
White blood cell count decreased (Recovered / Resolved); Influenza (Recovered / Resolved); Lymphocyte count decreased (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Action: Drug Withdrawn, Additional: Yes; AVONEX (Suspect), Active: INTERFERON BETA-1A, Action: Dose not changed; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Dosage: STARTING DOSE, Action: Drug Withdrawn, Additional: Yes; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Dosage: MAINTENANCE DOSE, Action: Drug Withdrawn, Additional: Yes; TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Indication: MULTIPLE SCLEROSIS, Action: Drug Withdrawn, Additional: Yes
|
['avonex', 'tecfidera']
|
['dimethyl fumarate', 'interferon beta-1a']
|
['multiple sclerosis']
|
14,638,056
| 2
|
Japan
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-022443
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Male
|
Pain in extremity (Not Recovered / Not Resolved / Ongoing); Dizziness (Recovered / Resolved); Oedema peripheral (Recovered / Resolved)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, QD, Indication: RENAL CELL CARCINOMA, Action: Dose not changed
|
['nivolumab']
|
['nivolumab']
|
['renal cell carcinoma']
|
14,639,141
| 2
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,315
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-009219
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Female
|
Diarrhoea (Recovering / Resolving); Histiocytosis haematophagic (Recovering / Resolving)
|
VEMURAFENIB. (Suspect), Active: VEMURAFENIB, Dosage: 720 MG, QD, Indication: MALIGNANT MELANOMA, Action: Unknown, Additional: Doesn't Apply; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, QD, Indication: MALIGNANT MELANOMA, Action: Unknown, Additional: Doesn't Apply; MEKINIST (Suspect), Active: TRAMETINIB DIMETHYL SULFOXIDE, Dosage: 2 MG, QD, Indication: MALIGNANT MELANOMA, Action: Unknown, Additional: Doesn't Apply; TAFINLAR (Suspect), Active: DABRAFENIB MESYLATE, Dosage: 300 MG, QD, Indication: MALIGNANT MELANOMA, Action: Unknown, Additional: Doesn't Apply; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 2 MG/KG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['mekinist', 'vemurafenib.', 'nivolumab', 'tafinlar']
|
['dabrafenib mesylate', 'nivolumab', 'trametinib dimethyl sulfoxide', 'vemurafenib']
|
['malignant melanoma', 'product used for unknown indication']
|
14,648,479
| 3
|
Italy
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
IT-PFIZER INC-2018105540
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Abdominal pain (Recovering / Resolving); Faecaloma (Recovering / Resolving)
|
TORVAST (Suspect), Active: ATORVASTATIN, Dosage: 80 MG, 1X/DAY, Action: Unknown, Additional: Doesn't Apply; PANTORC (Suspect), Active: PANTOPRAZOLE SODIUM, Dosage: 40 MG, 1X/DAY, Action: Unknown, Additional: Doesn't Apply
|
['torvast', 'pantorc']
|
['pantoprazole sodium', 'atorvastatin']
|
[]
|
14,649,560
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
US-SA-2018SA077169
|
Regulatory Authority
|
FDA-Public Use
| 86
|
Year
|
Female
|
Knee arthroplasty (Recovering / Resolving)
|
ALIROCUMAB PREFILLED PEN (Suspect), Active: ALIROCUMAB, Indication: BLOOD CHOLESTEROL INCREASED, Action: Dose not changed; PRALUENT (Suspect), Active: ALIROCUMAB, Indication: BLOOD CHOLESTEROL INCREASED, Action: Dose not changed
|
['alirocumab prefilled pen', 'praluent']
|
['alirocumab']
|
['blood cholesterol increased']
|
14,650,322
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,180,316
| 20,180,711
|
US-ELI_LILLY_AND_COMPANY-US201803005494
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Female
|
Blood glucose increased (Recovering / Resolving); Glycosylated haemoglobin increased (Recovering / Resolving)
|
BASAGLAR (Suspect), Active: INSULIN GLARGINE, Dosage: 80 U, UNKNOWN, Indication: TYPE 2 DIABETES MELLITUS, Action: Dose not changed; BASAGLAR (Suspect), Active: INSULIN GLARGINE, Dosage: 80 U, UNKNOWN, Action: Dose not changed
|
['basaglar']
|
['insulin glargine']
|
['type 2 diabetes mellitus']
|
14,651,347
| 3
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,316
| 20,180,711
|
DE-009507513-1803DEU006050
|
Regulatory Authority
|
FDA-Public Use
| 85
|
Year
|
Male
|
Malignant neoplasm progression (Fatal); Fatigue (Fatal)
|
KEYTRUDA (Suspect), Active: PEMBROLIZUMAB, Dosage: 200 MG, UNK, Indication: TRANSITIONAL CELL CARCINOMA, Action: Not applicable; KEYTRUDA (Suspect), Active: PEMBROLIZUMAB, Indication: METASTATIC NEOPLASM, Action: Not applicable
|
['keytruda']
|
['pembrolizumab']
|
['metastatic neoplasm', 'transitional cell carcinoma']
|
14,634,816
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
PHEH2018US009758
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Psoriatic arthropathy (Not Recovered / Not Resolved / Ongoing)
|
SIMPONI (Suspect), Active: GOLIMUMAB, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; ENBREL (Suspect), Active: ETANERCEPT, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; SULFASALAZINE. (Suspect), Active: SULFASALAZINE, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; REMICADE (Suspect), Active: INFLIXIMAB, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply; COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: UNK, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply
|
['cosentyx', 'methotrexate.', 'sulfasalazine.', 'enbrel', 'simponi', 'remicade', 'humira']
|
['infliximab', 'etanercept', 'golimumab', 'secukinumab', 'methotrexate', 'adalimumab', 'sulfasalazine']
|
['psoriatic arthropathy']
|
14,635,742
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,314
| 20,180,711
|
US-APOTEX-2018AP008264
|
Regulatory Authority
|
FDA-Public Use
| 53
|
Year
|
Male
|
Pneumocystis jirovecii pneumonia (Recovering / Resolving); Acute respiratory distress syndrome (Recovering / Resolving); Influenza (Recovering / Resolving)
|
METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Dosage: 24 MG, DAILY, Indication: GRAFT VERSUS HOST DISEASE, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Indication: GRAFT VERSUS HOST DISEASE, Action: Unknown, Additional: Doesn't Apply; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: UNK, Indication: GRAFT VERSUS HOST DISEASE, Action: Unknown, Additional: Doesn't Apply; METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Dosage: 35 MG, BID, Action: Unknown, Additional: Doesn't Apply; METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PENTAMIDINE (Suspect), Active: PENTAMIDINE, Indication: PROPHYLAXIS, Action: Not applicable; PENTAMIDINE (Suspect), Active: PENTAMIDINE, Dosage: 300 MG, UNK, Indication: PNEUMOCYSTIS JIROVECII PNEUMONIA, Action: Not applicable; TRIMETHOPRIM SULFAMETHOXAZOLE (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Dosage: UNK, Indication: PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes; TRIMETHOPRIM SULFAMETHOXAZOLE (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Dosage: UNK, Indication: PNEUMOCYSTIS JIROVECII PNEUMONIA, Action: Drug Withdrawn, Additional: Yes; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Unknown, Additional: Doesn't Apply; ACYCLOVIR. (Suspect), Active: ACYCLOVIR, Indication: PROPHYLAXIS, Action: Not applicable
|
['trimethoprim sulfamethoxazole', 'pentamidine', 'methylprednisolone.', 'tacrolimus.', 'acyclovir.', 'mycophenolate']
|
['sulfamethoxazole\\trimethoprim', 'methylprednisolone', 'mycophenolic acid', 'pentamidine', 'acyclovir', 'tacrolimus']
|
['prophylaxis', 'pneumocystis jirovecii pneumonia', 'immunosuppressant drug therapy', 'graft versus host disease']
|
14,636,676
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,314
| 20,180,711
|
GB-CELLTRION INC.-2018GB018443
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Urosepsis (Fatal); Acute kidney injury (Fatal); Cognitive disorder (Fatal)
|
REMSIMA (Suspect), Active: INFLIXIMAB, Dosage: 200 MG, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable; REMSIMA (Suspect), Active: INFLIXIMAB, Dosage: 200 MG, Action: Not applicable
|
['remsima']
|
['infliximab']
|
['rheumatoid arthritis']
|
14,638,101
| 2
|
Canada
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,314
| 20,180,711
|
CA-TEVA-2018-CA-869771
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Male
|
Respiratory acidosis (Recovered / Resolved); Euglycaemic diabetic ketoacidosis (Recovered / Resolved); Metabolic acidosis (Recovered / Resolved)
|
EMPAGLIFLOZIN (Suspect), Active: EMPAGLIFLOZIN, Dosage: 25 MG DAILY, Indication: TYPE 2 DIABETES MELLITUS, Action: Not applicable; PROPOFOL. (Suspect), Active: PROPOFOL, Indication: SEDATIVE THERAPY, Action: Not applicable
|
['propofol.', 'empagliflozin']
|
['propofol', 'empagliflozin']
|
['type 2 diabetes mellitus', 'sedative therapy']
|
14,643,796
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,315
| 20,180,711
|
US-TEVA-2018-US-869752
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Female
|
Cardiomyopathy (Fatal); Cardiac failure (Fatal)
|
HYDROXYCHLOROQUINE (Suspect), Active: HYDROXYCHLOROQUINE, Indication: SYSTEMIC LUPUS ERYTHEMATOSUS, Action: Drug Withdrawn
|
['hydroxychloroquine']
|
['hydroxychloroquine']
|
['systemic lupus erythematosus']
|
14,648,583
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
FR-MYLANLABS-2018M1015875
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Male
|
Intervertebral discitis (Not Recovered / Not Resolved / Ongoing); Condition aggravated (Not Recovered / Not Resolved / Ongoing)
|
PIPERACILLIN,TAZOBACTAM MYLAN (Suspect), Active: PIPERACILLIN SODIUM\TAZOBACTAM SODIUM, Dosage: 12 G, QD, Indication: INTERVERTEBRAL DISCITIS, Action: Drug Withdrawn, Additional: No
|
['piperacillin,tazobactam mylan']
|
['piperacillin sodium\\tazobactam sodium']
|
['intervertebral discitis']
|
14,648,589
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
FR-MYLANLABS-2018M1015871
|
Regulatory Authority
|
FDA-Public Use
| 88
|
Year
|
Female
|
Hypotension (Recovered / Resolved); Somnolence (Recovered / Resolved); Bradycardia (Recovered / Resolved)
|
CLOPIDOGREL (Suspect), Active: CLOPIDOGREL BISULFATE, Dosage: 75 MG, QD, Action: Unknown, Additional: Doesn't Apply; SERESTA (Suspect), Active: OXAZEPAM, Dosage: 10 MG, QD, Indication: ANXIETY, Action: Unknown, Additional: Doesn't Apply; RAMIPRIL. (Suspect), Active: RAMIPRIL, Dosage: 5 MG, QD, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; ESOMEPRAZOLE (Suspect), Active: ESOMEPRAZOLE, Dosage: 20 MG, QD, Indication: GASTROOESOPHAGEAL REFLUX DISEASE, Action: Unknown, Additional: Doesn't Apply; ATENOLOL. (Suspect), Active: ATENOLOL, Dosage: 50 MG, QD, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply
|
['clopidogrel', 'esomeprazole', 'atenolol.', 'ramipril.', 'seresta']
|
['ramipril', 'clopidogrel bisulfate', 'atenolol', 'esomeprazole', 'oxazepam']
|
['anxiety', 'hypertension', 'gastrooesophageal reflux disease']
|
14,635,784
| 3
|
Canada
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
CA-CELGENEUS-CAN-20180302949
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Joint range of motion decreased (Not Recovered / Not Resolved / Ongoing); Peripheral swelling (Not Recovered / Not Resolved / Ongoing); Drug ineffective (Not Recovered / Not Resolved / Ongoing); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing)
|
OTEZLA (Suspect), Active: APREMILAST, Indication: PSORIATIC ARTHROPATHY, Action: Dose not changed
|
['otezla']
|
['apremilast']
|
['psoriatic arthropathy']
|
14,638,129
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,314
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-022481
|
Regulatory Authority
|
FDA-Public Use
| 8
|
Decade
|
Female
|
Intestinal ulcer (Recovered / Resolved)
|
METFORMIN HYDROCHLORIDE. (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['metformin hydrochloride.']
|
['metformin hydrochloride']
|
['product used for unknown indication']
|
14,638,162
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,314
| 20,180,711
|
US-GE HEALTHCARE LIFE SCIENCES-2018CSU000677
|
Regulatory Authority
|
FDA-Public Use
| 91
|
Year
|
Female
|
Extravasation (Recovered / Resolved); Peripheral swelling (Recovered / Resolved)
|
OMNIPAQUE (Suspect), Active: IOHEXOL, Dosage: 50 ML, SINGLE, Indication: PERIPHERAL ARTERY THROMBOSIS, Action: Not applicable
|
['omnipaque']
|
['iohexol']
|
['peripheral artery thrombosis']
|
14,639,240
| 2
|
Germany
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,315
| 20,180,711
|
DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-022652
|
Regulatory Authority
|
FDA-Public Use
| 20
|
Year
|
Male
|
Epistaxis (Recovered / Resolved); Cardiac valve disease (Recovering / Resolving)
|
ELIQUIS (Suspect), Active: APIXABAN, Dosage: UNK, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['eliquis']
|
['apixaban']
|
['cerebrovascular accident prophylaxis']
|
14,643,878
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,315
| 20,180,711
|
US-TEVA-2018-US-869768
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Female
|
Diabetic ketoacidosis (Recovered / Resolved); Pancreatitis (Recovered / Resolved); Stress cardiomyopathy (Recovered / Resolved)
|
ASPIRIN. (Suspect), Active: ASPIRIN, Dosage: 81 MG DAILY, Indication: PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply; ATORVASTATIN (Suspect), Active: ATORVASTATIN, Dosage: 20 MG DAILY, Indication: HYPERLIPIDAEMIA, Action: Unknown, Additional: Doesn't Apply; LISINOPRIL. (Suspect), Active: LISINOPRIL, Dosage: 5 MG DAILY, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; GARCINIA CAMBOGIA (Suspect), Active: HERBALS\GARCINIA CAMBOGIA FRUIT, Dosage: TWO TABLETS THREE TIMES A DAY WITH MEALS, Indication: WEIGHT DECREASED, Action: Drug Withdrawn, Additional: Yes; HYDROCHLOROTHIAZIDE. (Suspect), Active: HYDROCHLOROTHIAZIDE, Dosage: 12.5 MG DAILY, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply
|
['aspirin.', 'metformin', 'atorvastatin', 'lisinopril.', 'garcinia cambogia', 'hydrochlorothiazide.']
|
['lisinopril', 'herbals\\garcinia cambogia fruit', 'hydrochlorothiazide', 'atorvastatin', 'aspirin', 'metformin hydrochloride']
|
['prophylaxis', 'hyperlipidaemia', 'weight decreased', 'diabetes mellitus', 'hypertension']
|
14,648,666
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
US-JNJFOC-20180313086
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Increased viscosity of upper respiratory secretion (Recovered / Resolved); Epistaxis (Recovered / Resolved)
|
XARELTO (Suspect), Active: RIVAROXABAN, Dosage: ONCE A DAY IN THE EVENING., Indication: ATRIAL FIBRILLATION, Action: Not applicable; XARELTO (Suspect), Active: RIVAROXABAN, Dosage: ONCE A DAY IN THE EVENING., Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Not applicable
|
['xarelto']
|
['rivaroxaban']
|
['cerebrovascular accident prophylaxis', 'atrial fibrillation']
|
14,648,682
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-NB-001272
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Male
|
Dyspnoea (Recovering / Resolving)
|
OFEV (Suspect), Active: NINTEDANIB, Indication: IDIOPATHIC PULMONARY FIBROSIS, Action: Dose not changed
|
['ofev']
|
['nintedanib']
|
['idiopathic pulmonary fibrosis']
|
14,649,657
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
PHEH2018US009764
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Dyspnoea (Recovering / Resolving)
|
ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 100 MG, BID, Action: Dose Increased; ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 50 MG, BID, Indication: CARDIAC FAILURE CHRONIC, Action: Dose Increased; ALBUTEROL. (Suspect), Active: ALBUTEROL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['albuterol.', 'entresto']
|
['sacubitril\\valsartan', 'albuterol']
|
['product used for unknown indication', 'cardiac failure chronic']
|
14,634,979
| 2
|
Italy
|
Report from study
|
No
| null | 20,180,314
| 20,180,711
|
IT-BIOVERATIV-2018BV000120
|
Regulatory Authority
|
FDA-Public Use
| 3
|
Year
|
Male
|
Pyrexia (Recovered / Resolved); Bacterial infection (Recovered / Resolved)
|
ELOCTA (Suspect), Active: EFMOROCTOCOG ALFA, Indication: FACTOR VIII DEFICIENCY, Action: Dose not changed; ELOCTA (Suspect), Active: EFMOROCTOCOG ALFA, Action: Dose not changed
|
['elocta']
|
['efmoroctocog alfa']
|
['factor viii deficiency']
|
14,635,821
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
US-JNJFOC-20180308395
|
Regulatory Authority
|
FDA-Public Use
| 53
|
Year
|
Female
|
Nausea (Recovered / Resolved); Loss of consciousness (Recovered / Resolved); Malaise (Recovered / Resolved)
|
SIMPONI (Suspect), Active: GOLIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable
|
['simponi']
|
['golimumab']
|
['rheumatoid arthritis']
|
14,644,042
| 2
|
Germany
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,315
| 20,180,711
|
DE-PFIZER INC-2018104058
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Transient ischaemic attack (Recovered / Resolved)
|
ESTRADIOL. (Suspect), Active: ESTRADIOL, Dosage: UNK, Action: Dose not changed; GYNODIAN DEPOT (ESTRADIOL VALERATE - PRASTERONE ENANTATE) (Suspect), Active: ESTRADIOL VALERATE\PRASTERONE ENANTATE, Dosage: 1ML, 1, 1 AS NECESSARY (1 ML,1 IN 1 AS REQUIRED), Action: Not applicable
|
['estradiol.', 'gynodian depot (estradiol valerate - prasterone enantate)']
|
['estradiol', 'estradiol valerate\\prasterone enantate']
|
[]
|
14,635,065
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
US-ABBVIE-18K-163-2285144-00
|
Regulatory Authority
|
FDA-Public Use
| 50
|
Year
|
Female
|
Influenza (Recovered / Resolved)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis', 'crohn^s disease']
|
14,640,422
| 5
|
United States of America
|
Spontaneous
|
No
| null | 20,180,315
| 20,180,711
|
US-PFIZER INC-2018098699
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Female
|
Neutrophil count decreased (Recovering / Resolving); White blood cell count decreased (Recovering / Resolving)
|
PALBOCICLIB (Suspect), Active: PALBOCICLIB, Dosage: 100 MG, DAILY, Action: Unknown, Additional: Doesn't Apply; PALBOCICLIB (Suspect), Active: PALBOCICLIB, Dosage: 125 MG, CYCLIC (DAILY 21 DAYS ON 7 DAYS OFF), Indication: BREAST CANCER METASTATIC, Action: Unknown, Additional: Doesn't Apply
|
['palbociclib']
|
['palbociclib']
|
['breast cancer metastatic']
|
14,644,116
| 2
|
Poland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,315
| 20,180,711
|
PL-PFIZER INC-2018102066
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Somnolence (Recovered / Resolved); Tonic clonic movements (Recovered / Resolved)
|
LYRICA (Suspect), Active: PREGABALIN, Dosage: 75 MG, 2X/DAY FOR ONE WEEK, Indication: PAIN, Action: Drug Withdrawn, Additional: Yes; LYRICA (Suspect), Active: PREGABALIN, Dosage: 75 MG, 1X/DAY, Action: Drug Withdrawn, Additional: Yes; LYRICA (Suspect), Active: PREGABALIN, Dosage: 300 MG, DAILY, Indication: OVARIAN CANCER, Action: Drug Withdrawn, Additional: Yes
|
['lyrica']
|
['pregabalin']
|
['pain', 'ovarian cancer']
|
14,647,864
| 3
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
US-PFIZER INC-2018105821
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Concussion (Recovering / Resolving); Rib fracture (Not Recovered / Not Resolved / Ongoing); Laceration (Recovered / Resolved); Laceration (Recovered / Resolved); Vertigo (Recovered / Resolved)
|
FILGOTINIB VS PLACEBO (CODE NOT BROKEN) (Suspect), Active: FILGOTINIB, Dosage: BLINDED THERAPY (1 DF, QD), Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['filgotinib vs placebo (code not broken)']
|
['filgotinib']
|
['rheumatoid arthritis']
|
14,649,794
| 2
|
France
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
FR-PFIZER INC-2018101312
|
Regulatory Authority
|
FDA-Public Use
| 5
|
Year
|
Female
|
Aspartate aminotransferase increased (Recovered / Resolved); Gamma-glutamyltransferase increased (Recovered / Resolved); Alanine aminotransferase increased (Recovered / Resolved)
|
CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: 770 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; VINCRISTINE SULFATE. (Suspect), Active: VINCRISTINE SULFATE, Dosage: 1.1 MG, 1X/DAY:QD, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; ONCASPAR (Suspect), Active: PEGASPARGASE, Dosage: 940 IU, 1X/DAY:QD, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: 12 MG, 1X/DAY:QD, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; CYTARABINE. (Suspect), Active: CYTARABINE, Dosage: 60 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DOXORUBICIN HCL (Suspect), Active: DOXORUBICIN HYDROCHLORIDE, Dosage: 19.7 MG, 1X/DAY:QD, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Dosage: 7.5 MG, 1X/DAY:QD, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; 6-MERCAPTOPURINE MONOHYDRATE (Suspect), Active: MERCAPTOPURINE, Dosage: 45.6 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['cyclophosphamide.', 'vincristine sulfate.', 'methotrexate.', 'doxorubicin hcl', 'oncaspar', 'dexamethasone.', '6-mercaptopurine monohydrate', 'cytarabine.']
|
['pegaspargase', 'vincristine sulfate', 'cyclophosphamide', 'mercaptopurine', 'doxorubicin hydrochloride', 'methotrexate', 'dexamethasone', 'cytarabine']
|
['acute lymphocytic leukaemia']
|
14,636,784
| 2
|
France
|
Report from study
|
Yes
|
Death (Yes)
| 20,180,314
| 20,180,711
|
FR-ASTRAZENECA-2018SE32107
|
Regulatory Authority
|
FDA-Public Use
| 39
|
Year
|
Male
|
Thrombocytopenia (Fatal)
|
DURVALUMAB. (Suspect), Active: DURVALUMAB, Indication: LUNG ADENOCARCINOMA STAGE IV, Action: Unknown, Additional: Doesn't Apply
|
['durvalumab.']
|
['durvalumab']
|
['lung adenocarcinoma stage iv']
|
14,646,288
| 4
|
Germany
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
DE-HORIZON-RAV-0041-2018
|
Regulatory Authority
|
FDA-Public Use
| 11
|
Year
|
Female
|
Psychomotor hyperactivity (Recovered / Resolved); Vomiting (Recovered / Resolved); Hallucination (Recovered / Resolved); Headache (Recovered / Resolved); Dizziness (Recovered / Resolved); Gastrointestinal infection (Recovered / Resolved); Nausea (Recovered / Resolved)
|
RAVICTI (Suspect), Active: GLYCEROL PHENYLBUTYRATE, Dosage: 3 TIMES DAILY (3 X 2,7 ML PER DAY), Indication: UREA CYCLE DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['ravicti']
|
['glycerol phenylbutyrate']
|
['urea cycle disorder']
|
14,651,589
| 5
|
Peru
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,317
| 20,180,711
|
PE-ABBVIE-18K-127-2281166-00
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Female
|
Diarrhoea (Recovered / Resolved); Dyspnoea (Recovering / Resolving); Salivary hypersecretion (Recovering / Resolving); Headache (Not Recovered / Not Resolved / Ongoing)
|
ETHAMBUTOL (Suspect), Active: ETHAMBUTOL HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; PYRAZINAMIDE. (Suspect), Active: PYRAZINAMIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply; RIFAMPICINE (Suspect), Active: RIFAMPIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['ethambutol', 'pyrazinamide.', 'rifampicine', 'humira']
|
['ethambutol hydrochloride', 'rifampin', 'pyrazinamide', 'adalimumab']
|
['crohn^s disease', 'product used for unknown indication']
|
14,642,725
| 3
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,315
| 20,180,711
|
BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-014607
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Brain compression (Recovered / Resolved)
|
ATENSINA (Suspect), Active: CLONIDINE, Indication: HYPERTENSION, Action: Drug Withdrawn, Additional: Yes; ATENSINA (Suspect), Active: CLONIDINE, Action: Drug Withdrawn, Additional: Yes
|
['atensina']
|
['clonidine']
|
['hypertension']
|
14,644,859
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,315
| 20,180,711
|
PHEH2018US010233
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Needle issue (Not Recovered / Not Resolved / Ongoing)
|
SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 30 MG, QMO, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed
|
['sandostatin lar depot']
|
['octreotide acetate']
|
['product used for unknown indication']
|
14,641,588
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,315
| 20,180,711
|
US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-022912
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Male
|
Multiple organ dysfunction syndrome (Fatal); Hyponatraemia (Recovering / Resolving); Back pain (Recovering / Resolving)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 240 MG, UNK, Indication: EXTRAMAMMARY PAGET^S DISEASE, Action: Unknown, Additional: Doesn't Apply; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Indication: SARCOMA, Action: Unknown, Additional: Doesn't Apply; IPILIMUMAB (Suspect), Active: IPILIMUMAB, Dosage: 97 MG, UNK, Indication: EXTRAMAMMARY PAGET^S DISEASE, Action: Unknown, Additional: Doesn't Apply; FUROSEMIDE. (Suspect), Active: FUROSEMIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['furosemide.', 'nivolumab', 'ipilimumab']
|
['nivolumab', 'furosemide', 'ipilimumab']
|
['sarcoma', 'product used for unknown indication', 'extramammary paget^s disease']
|
14,646,421
| 2
|
Canada
|
Other
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
CA-APOTEX-2018AP007708
|
Regulatory Authority
|
FDA-Public Use
| 87
|
Year
|
Female
|
Erythema (Recovered / Resolved); Oedema peripheral (Recovered / Resolved); Walking disability (Recovered / Resolved); Arthralgia (Recovered / Resolved)
|
CIPROFLOXACIN INTRAVENOUS INFUSION, BP (Suspect), Active: CIPROFLOXACIN, Dosage: 400 MG, BID, Indication: BACTERIURIA, Action: Unknown, Additional: Doesn't Apply
|
['ciprofloxacin intravenous infusion, bp']
|
['ciprofloxacin']
|
['bacteriuria']
|
14,647,921
| 3
|
Japan
|
Spontaneous
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,316
| 20,180,711
|
JP-OTSUKA-2018_006609
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Male
|
Liver disorder (Recovering / Resolving)
|
ANCARON (Suspect), Active: AMIODARONE HYDROCHLORIDE, Dosage: 750 MG, QD, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; SAMSCA (Suspect), Active: TOLVAPTAN, Dosage: 7.5 MG, QD, Indication: CARDIAC FAILURE CONGESTIVE, Action: Drug Withdrawn, Additional: Yes
|
['samsca', 'ancaron']
|
['tolvaptan', 'amiodarone hydrochloride']
|
['atrial fibrillation', 'cardiac failure congestive']
|
14,647,981
| 5
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,316
| 20,180,711
|
US-PFIZER INC-2018098283
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Female
|
Mental status changes (Recovered / Resolved)
|
HYDROXYZINE (Suspect), Active: HYDROXYZINE HYDROCHLORIDE, Dosage: 25 MG, 4X/DAY, Indication: PRURITUS, Action: Drug Withdrawn, Additional: Yes; BLINDED PLACEBO (Suspect), Active: INVESTIGATIONAL PRODUCT, Dosage: INFUSED OVER 20 MINUTES X1 DOSE (LOADING DOSE)., Indication: SICKLE CELL ANAEMIA WITH CRISIS, Action: Drug Withdrawn, Additional: Yes; BLINDED PF-06460031 (Suspect), Active: RIVIPANSEL, Dosage: INFUSED OVER 20 MINUTES X1 DOSE (LOADING DOSE)., Indication: SICKLE CELL ANAEMIA WITH CRISIS, Action: Drug Withdrawn, Additional: Yes; BENADRYL (Suspect), Active: DIPHENHYDRAMINE HYDROCHLORIDE, Dosage: 25 MG, 1 DOSE, Indication: PRURITUS, Action: Drug Withdrawn, Additional: Yes; MORPHINE SULFATE. (Suspect), Active: MORPHINE SULFATE, Dosage: 5 MG/ML IN 30 ML NORMAL SALINE (1 MG= PCA DOSE, 2MG= LOADING DOSE AND 0MG/HR BASAL RATE, Indication: SICKLE CELL ANAEMIA WITH CRISIS, Action: Drug Withdrawn, Additional: Yes
|
['morphine sulfate.', 'benadryl', 'hydroxyzine', 'blinded pf-06460031', 'blinded placebo']
|
['diphenhydramine hydrochloride', 'hydroxyzine hydrochloride', 'rivipansel', 'investigational product', 'morphine sulfate']
|
['pruritus', 'sickle cell anaemia with crisis']
|
14,649,064
| 3
|
China
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,316
| 20,180,711
|
CN-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-023313
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Male
|
Liver injury (Recovering / Resolving)
|
BLINDED IPILIMUMAB (Suspect), Active: IPILIMUMAB, Dosage: 82.8 MG, UNK, Indication: SMALL CELL LUNG CANCER EXTENSIVE STAGE, Action: Drug Withdrawn, Additional: Yes; BLINDED NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 82.8 MG, UNK, Indication: SMALL CELL LUNG CANCER EXTENSIVE STAGE, Action: Drug Withdrawn, Additional: Yes; BLINDED PLACEBO (Suspect), Active: INVESTIGATIONAL PRODUCT, Dosage: 82.8 MG, UNK, Indication: SMALL CELL LUNG CANCER EXTENSIVE STAGE, Action: Drug Withdrawn, Additional: Yes
|
['blinded nivolumab', 'blinded placebo', 'blinded ipilimumab']
|
['nivolumab', 'investigational product', 'ipilimumab']
|
['small cell lung cancer extensive stage']
|
14,649,073
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,316
| 20,180,711
|
US-ABBVIE-18K-163-2289006-00
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Cardio-respiratory arrest (Fatal)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
14,640,689
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,315
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018GSK042690
|
Regulatory Authority
|
FDA-Public Use
| 45
|
Year
|
Female
|
Rash (Recovered / Resolved); Drug hypersensitivity (Recovered / Resolved); Urticaria (Recovered / Resolved); Pruritus (Recovered / Resolved); Generalised erythema (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Stridor (Recovered / Resolved); Erythema (Recovered / Resolved)
|
NUCALA (Suspect), Active: MEPOLIZUMAB, Dosage: 100 MG, UNK, Indication: ASTHMA, Action: Drug Withdrawn, Additional: Yes
|
['nucala']
|
['mepolizumab']
|
['asthma']
|
14,641,613
| 3
|
United States of America
|
Report from study
|
No
| null | 20,180,315
| 20,180,711
|
US-ALEXION PHARMACEUTICALS INC.-A201708037
|
Regulatory Authority
|
FDA-Public Use
| 29
|
Year
|
Female
|
Pregnancy (Recovered / Resolved)
|
ECULIZUMAB (Suspect), Active: ECULIZUMAB, Dosage: 1200 MG, Q2W, Indication: HAEMOLYTIC URAEMIC SYNDROME, Action: Dose not changed
|
['eculizumab']
|
['eculizumab']
|
['haemolytic uraemic syndrome']
|
14,641,620
| 2
|
Japan
|
Report from study
|
Yes
|
Death (Yes)
| 20,180,315
| 20,180,711
|
JP-COLLEGIUM PHARMACEUTICAL, INC.-JP-2018DEP000606
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Metastases to liver (Fatal); Colon cancer metastatic (Fatal)
|
TAPENTADOL HYDROCHLORIDE (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: 50 MG, BID, Indication: CANCER PAIN, Action: Not applicable
|
['tapentadol hydrochloride']
|
['tapentadol hydrochloride']
|
['cancer pain']
|
14,642,850
| 2
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,315
| 20,180,711
|
JP-CELGENEUS-JPN-20171103372
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Female
|
Malaise (Recovered / Resolved); Decreased appetite (Recovered / Resolved); Hypocalcaemia (Recovered / Resolved); Electrocardiogram QT prolonged (Recovered / Resolved); Rash (Recovering / Resolving); Dysphonia (Recovering / Resolving); Platelet count decreased (Recovered / Resolved)
|
LENADEX (Suspect), Active: DEXAMETHASONE ACETATE, Dosage: 20 MILLIGRAM, Action: Drug Withdrawn, Additional: Yes; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 10 MILLIGRAM, Action: Drug Withdrawn, Additional: Yes; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 15 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; LENADEX (Suspect), Active: DEXAMETHASONE ACETATE, Dosage: 20 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; LENADEX (Suspect), Active: DEXAMETHASONE ACETATE, Dosage: 12 MILLIGRAM, Action: Drug Withdrawn, Additional: Yes
|
['revlimid', 'lenadex']
|
['dexamethasone acetate', 'lenalidomide']
|
['plasma cell myeloma']
|
14,642,916
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,315
| 20,180,711
|
US-ALEXION PHARMACEUTICALS INC.-A201802663
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Headache (Recovered / Resolved); Poor venous access (Recovered / Resolved); Fatigue (Recovered / Resolved)
|
SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['soliris']
|
['eculizumab']
|
['product used for unknown indication']
|
14,646,469
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
US-ABBVIE-18K-163-2286564-00
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Female
|
Chronic kidney disease (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIASIS, Action: Dose not changed
|
['humira']
|
['adalimumab']
|
['psoriasis']
|
14,646,520
| 3
|
United States of America
|
Report from study
|
No
| null | 20,180,316
| 20,180,711
|
US-AMGEN-USASL2018036130
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Male
|
Influenza (Recovering / Resolving)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
14,649,119
| 4
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,316
| 20,180,711
|
US-GILEAD-2017-0310409
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Male
|
Dysgeusia (Not Recovered / Not Resolved / Ongoing); Fluid retention (Not Recovered / Not Resolved / Ongoing)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 10 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No; TYVASO (Suspect), Active: TREPROSTINIL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['tyvaso', 'ambrisentan']
|
['ambrisentan', 'treprostinil']
|
['product used for unknown indication']
|
14,635,397
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,314
| 20,180,711
|
US-ASTRAZENECA-2018SE20683
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Dysarthria (Recovered / Resolved)
|
FARXIGA (Suspect), Active: DAPAGLIFLOZIN PROPANEDIOL, Dosage: 5.0MG UNKNOWN, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes; FARXIGA (Suspect), Active: DAPAGLIFLOZIN PROPANEDIOL, Dosage: 10.0MG UNKNOWN, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes
|
['farxiga']
|
['dapagliflozin propanediol']
|
['type 2 diabetes mellitus']
|
14,658,398
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-PFIZER INC-2018098247
|
Regulatory Authority
|
FDA-Public Use
| 38
|
Year
|
Female
|
Pain (Not Recovered / Not Resolved / Ongoing)
|
XELJANZ XR (Suspect), Active: TOFACITINIB CITRATE, Dosage: 11 MG, ONCE DAILY, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable
|
['xeljanz xr']
|
['tofacitinib citrate']
|
['rheumatoid arthritis']
|
14,652,614
| 2
|
Canada
|
Other
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
CA-APOTEX-2018AP007741
|
Regulatory Authority
|
FDA-Public Use
| 44
|
Year
|
Male
|
Paranoia (Recovered / Resolved); Depression suicidal (Recovered / Resolved); Depressive symptom (Recovered / Resolved); Suicidal ideation (Recovered / Resolved); Tearfulness (Recovered / Resolved); Psychotic disorder (Recovered / Resolved); Drug interaction (Recovered / Resolved); Psychiatric decompensation (Recovered / Resolved); Psychomotor skills impaired (Recovered / Resolved); Anxiety (Recovered / Resolved); Depression (Recovered / Resolved)
|
RITONAVIR. (Suspect), Active: RITONAVIR, Dosage: UNK, Indication: HIV INFECTION, Action: Unknown, Additional: Doesn't Apply; BUPROPION HYDROCHLORIDE. (Suspect), Active: BUPROPION HYDROCHLORIDE, Dosage: UNK, Indication: DEPRESSION, Action: Unknown, Additional: Doesn't Apply; CLONAZEPAM. (Suspect), Active: CLONAZEPAM, Dosage: UNK, Indication: DEPRESSION, Action: Unknown, Additional: Doesn't Apply; ATAZANAVIR SULFATE. (Suspect), Active: ATAZANAVIR SULFATE, Dosage: UNK, Indication: HIV INFECTION, Action: Unknown, Additional: Doesn't Apply; QUETIAPINE. (Suspect), Active: QUETIAPINE, Dosage: UNK, Indication: DEPRESSION, Action: Unknown, Additional: Doesn't Apply; RALTEGRAVIR POTASSIUM (Suspect), Active: RALTEGRAVIR POTASSIUM, Dosage: 400 MG, BID, Indication: HIV INFECTION, Action: Unknown, Additional: Doesn't Apply; RISPERIDONE. (Suspect), Active: RISPERIDONE, Dosage: UNK, Indication: DEPRESSION, Action: Unknown, Additional: Doesn't Apply; CITALOPRAM (Suspect), Active: CITALOPRAM HYDROBROMIDE, Dosage: UNK, Indication: PSYCHOTIC DISORDER, Action: Unknown, Additional: Doesn't Apply; SUSTIVA (Suspect), Active: EFAVIRENZ, Dosage: UNK, Indication: HIV INFECTION, Action: Unknown, Additional: Doesn't Apply
|
['citalopram', 'raltegravir potassium', 'ritonavir.', 'sustiva', 'clonazepam.', 'atazanavir sulfate.', 'risperidone.', 'quetiapine.', 'bupropion hydrochloride.']
|
['ritonavir', 'raltegravir potassium', 'quetiapine', 'efavirenz', 'risperidone', 'citalopram hydrobromide', 'atazanavir sulfate', 'clonazepam', 'bupropion hydrochloride']
|
['hiv infection', 'depression', 'psychotic disorder']
|
14,654,496
| 2
|
Canada
|
Other
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
CA-APOTEX-2018AP007753
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Female
|
Pneumonia (Not Recovered / Not Resolved / Ongoing); Tremor (Not Recovered / Not Resolved / Ongoing); Insomnia (Not Recovered / Not Resolved / Ongoing); Hypertension (Not Recovered / Not Resolved / Ongoing)
|
CITALOPRAM (Suspect), Active: CITALOPRAM HYDROBROMIDE, Dosage: UNK, Indication: AGORAPHOBIA, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: 40 UNK, UNK ONE EVERY TWO WEEKS, Action: Unknown, Additional: Doesn't Apply; PROLIA (Suspect), Active: DENOSUMAB, Dosage: 60 MG, UNK ONE EVERY SIX MONTHS, Indication: AGORAPHOBIA, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: 40 MG, UNK ONE EVERY TWO WEEKS, Indication: ANKYLOSING SPONDYLITIS, Action: Unknown, Additional: Doesn't Apply
|
['citalopram', 'humira', 'prolia']
|
['citalopram hydrobromide', 'denosumab', 'adalimumab']
|
['agoraphobia', 'ankylosing spondylitis']
|
14,655,160
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,319
| 20,180,711
|
PHEH2018US010599
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Ejection fraction decreased (Recovering / Resolving)
|
ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: UNK UNK, BID, Indication: CARDIAC FAILURE, Action: Dose reduced, Additional: Yes; ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 1 DF (49MG SACUBITRIL/ 51MG VALSARTAN), UNK, Action: Dose reduced, Additional: Yes
|
['entresto']
|
['sacubitril\\valsartan']
|
['cardiac failure']
|
14,659,700
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-AMGEN-USASP2018036214
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Bronchitis (Recovering / Resolving); Pneumonia fungal (Recovered / Resolved); Respiratory failure (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: UNK, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
14,661,858
| 2
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,320
| 20,180,711
|
DE-BIOGEN-2018BI00543376
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Hepatic cancer (Fatal)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Not applicable; AVONEX (Suspect), Active: INTERFERON BETA-1A, Action: Not applicable
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
14,661,863
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,320
| 20,180,711
|
US-ALEXION PHARMACEUTICALS INC.-A201802718
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Gastric disorder (Not Recovered / Not Resolved / Ongoing); Peripheral swelling (Not Recovered / Not Resolved / Ongoing); Gastric dilatation (Not Recovered / Not Resolved / Ongoing)
|
SOLIRIS (Suspect), Active: ECULIZUMAB, Dosage: UNK, Indication: ATYPICAL HAEMOLYTIC URAEMIC SYNDROME, Action: Unknown, Additional: Doesn't Apply
|
['soliris']
|
['eculizumab']
|
['atypical haemolytic uraemic syndrome']
|
14,662,685
| 2
|
Argentina
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
AR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-024929
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Cardiac arrest (Fatal)
|
APIXABAN (Suspect), Active: APIXABAN, Dosage: 5 MG, UNK, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['apixaban']
|
['apixaban']
|
['cerebrovascular accident prophylaxis']
|
14,662,688
| 2
|
Canada
|
Other
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
CA-APOTEX-2017AP023943
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Male
|
Blood bilirubin increased (Not Recovered / Not Resolved / Ongoing); Blood sodium increased (Not Recovered / Not Resolved / Ongoing); Troponin I increased (Not Recovered / Not Resolved / Ongoing); Protein total increased (Not Recovered / Not Resolved / Ongoing); Haemoglobin increased (Not Recovered / Not Resolved / Ongoing); Alanine aminotransferase increased (Not Recovered / Not Resolved / Ongoing); Chronic kidney disease (Not Recovered / Not Resolved / Ongoing); Neuroleptic malignant syndrome (Not Recovered / Not Resolved / Ongoing); Bilirubin urine present (Not Recovered / Not Resolved / Ongoing); Blood phosphorus increased (Not Recovered / Not Resolved / Ongoing); Blood calcium decreased (Not Recovered / Not Resolved / Ongoing); Blood glucose increased (Not Recovered / Not Resolved / Ongoing); Adjusted calcium increased (Not Recovered / Not Resolved / Ongoing)
|
CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 75 MG, 1 EVERY 1 DAY, Action: Unknown, Additional: Doesn't Apply; RISPERIDONE. (Suspect), Active: RISPERIDONE, Dosage: 4 MG,1 EVERY 1 DAY, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 125 MG, UNK, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 50 MG, 1 EVERY 1 DAY, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 100 MG, UNK, Indication: SCHIZOPHRENIA, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 25 MG, 1 EVERY 1 DAY, Action: Unknown, Additional: Doesn't Apply; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: 75 MG, UNK, Indication: PSYCHOTIC DISORDER, Action: Unknown, Additional: Doesn't Apply; ABILIFY (Suspect), Active: ARIPIPRAZOLE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; RISPERIDONE. (Suspect), Active: RISPERIDONE, Dosage: 3 MG, 1 EVERY 1 DAY, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['abilify', 'clozapine.', 'risperidone.']
|
['clozapine', 'aripiprazole', 'risperidone']
|
['schizophrenia', 'product used for unknown indication', 'psychotic disorder']
|
14,664,300
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,321
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018046809
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Drug ineffective (Recovered / Resolved); Drug dose omission (Recovered / Resolved); Dyspnoea (Recovered / Resolved)
|
BREO ELLIPTA (Suspect), Active: FLUTICASONE FUROATE\VILANTEROL TRIFENATATE, Dosage: 1 PUFF(S), QD, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['breo ellipta']
|
['fluticasone furoate\\vilanterol trifenatate']
|
['chronic obstructive pulmonary disease']
|
14,664,302
| 2
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,321
| 20,180,711
|
DE-APOTEX-2018AP008412
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Fatigue (Fatal); Paranoia (Fatal); Aggression (Fatal); Hangover (Fatal); Sleep disorder (Fatal); Condition aggravated (Fatal); Completed suicide (Fatal); Rebound effect (Fatal); Delirium (Fatal); Agitation (Fatal); Product use in unapproved indication (Fatal); Withdrawal syndrome (Fatal); Off label use (Fatal); Paradoxical drug reaction (Fatal)
|
DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: DOSE INCREASED, TWO DIVIDED DOSES, Indication: AGGRESSION, Action: Not applicable; FORMOTEROL FUMARATE (Suspect), Active: FORMOTEROL FUMARATE, Dosage: 20 MG, QD, Indication: PNEUMONIA, Action: Not applicable; PAROXETINE. (Suspect), Active: PAROXETINE, Dosage: UNK, Action: Not applicable; DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: 40 MG, DIVIDED INTO 2 DOSAGES, Action: Not applicable; DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: DOSE INCREASED, TWO DIVIDED DOSES, Action: Not applicable; QUETIAPINE. (Suspect), Active: QUETIAPINE, Dosage: 150 MG, QD, Indication: DEMENTIA WITH LEWY BODIES, Action: Not applicable; DRONABINOL. (Suspect), Active: DRONABINOL, Dosage: 2.5 MG, QD, Indication: DELIRIUM, Action: Not applicable; FLUPENTIXOL (Suspect), Active: FLUPENTIXOL, Dosage: UNK, Indication: PNEUMONIA, Action: Not applicable; QUETIAPINE. (Suspect), Active: QUETIAPINE, Dosage: UNK, Indication: DELIRIUM, Action: Not applicable; SPIRIVA (Suspect), Active: TIOTROPIUM BROMIDE MONOHYDRATE, Dosage: UNK, Indication: PNEUMONIA, Action: Not applicable; DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: 24 MG, QD, Indication: DEMENTIA WITH LEWY BODIES, Action: Not applicable; FLUPENTIXOL (Suspect), Active: FLUPENTIXOL, Dosage: 20 MG, QD, Indication: DEMENTIA WITH LEWY BODIES, Action: Not applicable; DEXTROMETHORPHAN HYDROBROMIDE. (Suspect), Active: DEXTROMETHORPHAN HYDROBROMIDE, Dosage: UNK, Indication: DELIRIUM, Action: Not applicable; QUETIAPINE. (Suspect), Active: QUETIAPINE, Dosage: FINAL DOSE OF 100 MG/D, Action: Not applicable; FLUPENTIXOL (Suspect), Active: FLUPENTIXOL, Dosage: AS HIGH AS TOLERATED, Action: Not applicable; QUETIAPINE. (Suspect), Active: QUETIAPINE, Dosage: 150 MG, QD, Action: Not applicable; DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: UNK, Indication: DELIRIUM, Action: Not applicable; DRONABINOL. (Suspect), Active: DRONABINOL, Dosage: 15 MG, QD, Indication: AGGRESSION, Action: Not applicable; PAROXETINE. (Suspect), Active: PAROXETINE, Dosage: 10 MG, QD, Action: Not applicable; LORAZEPAM. (Suspect), Active: LORAZEPAM, Dosage: UNK, Indication: DEMENTIA WITH LEWY BODIES, Action: Not applicable; DEXTROMETHORPHAN HYDROBROMIDE. (Suspect), Active: DEXTROMETHORPHAN HYDROBROMIDE, Dosage: 24 MG, UNK, Action: Not applicable; LORAZEPAM. (Suspect), Active: LORAZEPAM, Dosage: UNK, Indication: DELIRIUM, Action: Not applicable; AMPICILLIN + SULBACTAM DELTASELECT (Suspect), Active: AMPICILLIN SODIUM\SULBACTAM SODIUM, Dosage: UNK, Indication: PNEUMONIA, Action: Unknown, Additional: Doesn't Apply; DEXTROMETHORPHAN (Suspect), Active: DEXTROMETHORPHAN, Dosage: 24 MG, UNK, Action: Not applicable; DRONABINOL. (Suspect), Active: DRONABINOL, Dosage: 2.5 UP TO 15 MG/D^2, Indication: DEMENTIA WITH LEWY BODIES, Action: Not applicable
|
['paroxetine.', 'formoterol fumarate', 'dextromethorphan hydrobromide.', 'flupentixol', 'dextromethorphan', 'lorazepam.', 'dronabinol.', 'quetiapine.', 'spiriva', 'ampicillin + sulbactam deltaselect']
|
['dronabinol', 'formoterol fumarate', 'paroxetine', 'flupentixol', 'dextromethorphan', 'quetiapine', 'dextromethorphan hydrobromide', 'lorazepam', 'tiotropium bromide monohydrate', 'ampicillin sodium\\sulbactam sodium']
|
['delirium', 'pneumonia', 'dementia with lewy bodies', 'aggression']
|
14,652,662
| 2
|
Canada
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
CA-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-096772
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Male
|
Malaise (Recovering / Resolving); Foot deformity (Not Recovered / Not Resolved / Ongoing); Feeling abnormal (Not Recovered / Not Resolved / Ongoing); Lower respiratory tract infection (Recovered / Resolved); Rheumatoid arthritis (Not Recovered / Not Resolved / Ongoing)
|
ABATACEPT (Suspect), Active: ABATACEPT, Dosage: 750 MG, Q4WK, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['abatacept']
|
['abatacept']
|
['rheumatoid arthritis']
|
14,654,507
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-APOTEX-2018AP005285
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Parosmia (Not Recovered / Not Resolved / Ongoing); Paraesthesia (Not Recovered / Not Resolved / Ongoing); Tenderness (Not Recovered / Not Resolved / Ongoing); Nausea (Not Recovered / Not Resolved / Ongoing); Abdominal discomfort (Not Recovered / Not Resolved / Ongoing); Musculoskeletal chest pain (Not Recovered / Not Resolved / Ongoing); Product odour abnormal (Not Recovered / Not Resolved / Ongoing)
|
SOTALOL. (Suspect), Active: SOTALOL, Dosage: 120 MG, BID, Indication: ARRHYTHMIA, Action: Dose not changed
|
['sotalol.']
|
['sotalol']
|
['arrhythmia']
|
14,654,517
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-APOTEX-2018AP008357
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Candida infection (Not Recovered / Not Resolved / Ongoing); Cellulitis staphylococcal (Recovering / Resolving); Gout (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing); Meniscus injury (Not Recovered / Not Resolved / Ongoing); Bronchitis (Recovered / Resolved); Oral pain (Not Recovered / Not Resolved / Ongoing); Condition aggravated (Not Recovered / Not Resolved / Ongoing); Psoriasis (Not Recovered / Not Resolved / Ongoing); Rhinorrhoea (Not Recovered / Not Resolved / Ongoing); Rash (Recovering / Resolving); Joint instability (Not Recovered / Not Resolved / Ongoing); Abdominal discomfort (Not Recovered / Not Resolved / Ongoing); Tongue discomfort (Not Recovered / Not Resolved / Ongoing); Tongue erythema (Not Recovered / Not Resolved / Ongoing)
|
ZYVOX (Suspect), Active: LINEZOLID, Dosage: UNK, Indication: CELLULITIS, Action: Dose not changed; CEFEPIME (Suspect), Active: CEFEPIME HYDROCHLORIDE, Dosage: UNK, Indication: CELLULITIS, Action: Dose not changed; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: 40 MG, ONCE IN TWO WEEKS, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn, Additional: Yes
|
['zyvox', 'humira', 'cefepime']
|
['linezolid', 'cefepime hydrochloride', 'adalimumab']
|
['psoriatic arthropathy', 'cellulitis']
|
14,655,944
| 4
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
US-JNJFOC-20180320634
|
Regulatory Authority
|
FDA-Public Use
| 20
|
Year
|
Female
|
Gastritis (Recovered / Resolved)
|
REMICADE (Suspect), Active: INFLIXIMAB, Indication: COLITIS ULCERATIVE, Action: Not applicable
|
['remicade']
|
['infliximab']
|
['colitis ulcerative']
|
14,655,958
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-CELGENEUS-USA-20180203842
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Weight increased (Not Recovered / Not Resolved / Ongoing)
|
REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 25 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Dose not changed
|
['revlimid']
|
['lenalidomide']
|
['plasma cell myeloma']
|
14,657,701
| 2
|
Brazil
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
BR-AMGEN-BRANI2018037018
|
Regulatory Authority
|
FDA-Public Use
| 34
|
Year
|
Female
|
Acute lymphocytic leukaemia recurrent (Fatal); Febrile neutropenia (Fatal)
|
BLINATUMOMAB (Suspect), Active: BLINATUMOMAB, Dosage: UNK, Indication: B PRECURSOR TYPE ACUTE LEUKAEMIA, Action: Not applicable
|
['blinatumomab']
|
['blinatumomab']
|
['b precursor type acute leukaemia']
|
14,658,476
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-PFIZER INC-2018112854
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Male
|
Diarrhoea (Not Recovered / Not Resolved / Ongoing); Asthenia (Not Recovered / Not Resolved / Ongoing); Decreased appetite (Not Recovered / Not Resolved / Ongoing); Abdominal discomfort (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing)
|
SUTENT (Suspect), Active: SUNITINIB MALATE, Dosage: 50 MG, CYCLIC[1 CAPSULE EVERY DAY FOR 14 DAYS, THEN 7 DAYS OFF], Action: Unknown, Additional: Doesn't Apply; SUTENT (Suspect), Active: SUNITINIB MALATE, Dosage: 50 MG, CYCLIC (1 CAPSULE BY MOUTH EVERY DAY FOR 14 DAYS, THEN 7 DAYS OFF), Indication: RENAL CANCER, Action: Unknown, Additional: Doesn't Apply
|
['sutent']
|
['sunitinib malate']
|
['renal cancer']
|
14,661,914
| 2
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
JP-AMGEN-JPNSP2018038512
|
Regulatory Authority
|
FDA-Public Use
| 7
|
Decade
|
Female
|
Dermatitis acneiform (Recovering / Resolving); Neurotoxicity (Recovering / Resolving); Dry skin (Recovering / Resolving)
|
OXALIPLATIN. (Suspect), Active: OXALIPLATIN, Dosage: UNK, Indication: COLON CANCER, Action: Unknown; VECTIBIX (Suspect), Active: PANITUMUMAB, Dosage: 6 MG/KG, Q2WEEKS, Action: Unknown, Additional: Doesn't Apply; VECTIBIX (Suspect), Active: PANITUMUMAB, Dosage: 6 MG/KG, Q2WEEKS, Indication: COLON CANCER, Action: Unknown, Additional: Doesn't Apply
|
['oxaliplatin.', 'vectibix']
|
['oxaliplatin', 'panitumumab']
|
['colon cancer']
|
14,664,316
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-015754
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Cardiac failure congestive (Fatal)
|
PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Dosage: STRENGTH: 75 MG; FORMULATION: CAPSULE, ACTION(S) TAKEN WITH PRODUCT: NOT REPORTED, Indication: ATRIAL FIBRILLATION, Action: Not applicable
|
['pradaxa']
|
['dabigatran etexilate mesylate']
|
['atrial fibrillation']
|
14,654,524
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-BAYER-2018-052892
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Male
|
Dizziness exertional (Recovered / Resolved)
|
ADEMPAS (Suspect), Active: RIOCIGUAT, Dosage: 1.5 MG, TID, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; ADEMPAS (Suspect), Active: RIOCIGUAT, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 10 MG, QD, Indication: PULMONARY HYPERTENSION, Action: Unknown
|
['adempas', 'ambrisentan']
|
['riociguat', 'ambrisentan']
|
['product used for unknown indication', 'pulmonary hypertension']
|
14,657,748
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
GB-SUN PHARMACEUTICAL INDUSTRIES LTD-2018RR-167165
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Male
|
Platelet count increased (Recovered / Resolved); Laboratory test abnormal (Not Recovered / Not Resolved / Ongoing); Blood creatinine increased (Recovered / Resolved); Pyrexia (Recovered / Resolved); C-reactive protein increased (Recovered / Resolved)
|
CIPROFLOXACIN. (Suspect), Active: CIPROFLOXACIN, Dosage: 500 MG, DAILY, Indication: OSTEOMYELITIS, Action: Unknown, Additional: Doesn't Apply; AMOXICILLIN. (Suspect), Active: AMOXICILLIN, Dosage: UNK, Indication: OSTEOMYELITIS, Action: Unknown, Additional: Doesn't Apply; RAMIPRIL. (Suspect), Active: RAMIPRIL, Dosage: 10 MG, DAILY, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; RAMIPRIL. (Suspect), Active: RAMIPRIL, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; TARGOCID (Suspect), Active: TEICOPLANIN, Dosage: 2200 MG, DAILY, Action: Dose not changed; TARGOCID (Suspect), Active: TEICOPLANIN, Dosage: 1100 MG, DAILY, Indication: ARTHRITIS INFECTIVE, Action: Dose not changed; TARGOCID (Suspect), Active: TEICOPLANIN, Dosage: 800 MG, UNK, Indication: OSTEOMYELITIS, Action: Dose not changed; TARGOCID (Suspect), Active: TEICOPLANIN, Action: Dose not changed
|
['amoxicillin.', 'targocid', 'ramipril.', 'ciprofloxacin.']
|
['ramipril', 'teicoplanin', 'amoxicillin', 'ciprofloxacin']
|
['hypertension', 'osteomyelitis', 'arthritis infective']
|
14,659,767
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
US-MYLANLABS-2018M1016568
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Syncope (Recovered / Resolved); Contusion (Recovered / Resolved); Ventricular tachyarrhythmia (Recovered / Resolved); Eyelid injury (Recovered / Resolved); Fall (Recovered / Resolved); Palpitations (Recovered / Resolved); Haematoma (Recovered / Resolved); Face injury (Recovered / Resolved); Facial bones fracture (Recovered / Resolved); Skin haemorrhage (Recovered / Resolved)
|
ANAGRELIDE. (Suspect), Active: ANAGRELIDE HYDROCHLORIDE, Dosage: UNK, Indication: ESSENTIAL THROMBOCYTHAEMIA, Action: Drug Withdrawn, Additional: Yes; HYDROXYCARBAMIDE (Suspect), Active: HYDROXYUREA, Indication: ESSENTIAL THROMBOCYTHAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['anagrelide.', 'hydroxycarbamide']
|
['hydroxyurea', 'anagrelide hydrochloride']
|
['essential thrombocythaemia']
|
14,659,788
| 3
|
United States of America
|
Other
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
US-INTERCEPT-PMOCA2018000386
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Anaemia (Recovered / Resolved); Gastric varices haemorrhage (Recovered / Resolved)
|
ASPIRIN /00002701/ (Suspect), Active: ASPIRIN, Action: Unknown; PLAVIX (Suspect), Active: CLOPIDOGREL BISULFATE, Action: Unknown; OCALIVA (Suspect), Active: OBETICHOLIC ACID, Dosage: 5 MG, QW, Action: Unknown; OCALIVA (Suspect), Active: OBETICHOLIC ACID, Dosage: 5 MG, QD, Indication: PRIMARY BILIARY CHOLANGITIS, Action: Unknown; OCALIVA (Suspect), Active: OBETICHOLIC ACID, Dosage: UNK, Action: Unknown
|
['ocaliva', 'plavix', 'aspirin /00002701/']
|
['obeticholic acid', 'aspirin', 'clopidogrel bisulfate']
|
['primary biliary cholangitis']
|
14,660,509
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018GSK046346
|
Regulatory Authority
|
FDA-Public Use
| 53
|
Year
|
Male
|
Blood glucose decreased (Recovered / Resolved); Drug dose omission (Recovered / Resolved)
|
TANZEUM (Suspect), Active: ALBIGLUTIDE, Dosage: 30 MG, WE, Indication: DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply
|
['tanzeum']
|
['albiglutide']
|
['diabetes mellitus']
|
14,663,608
| 3
|
Ireland
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
PHHY2018IE035219
|
Regulatory Authority
|
FDA-Public Use
| 69
|
Year
|
Female
|
Viral infection (Recovering / Resolving); Candida infection (Recovering / Resolving); Decreased appetite (Recovering / Resolving); Nausea (Recovering / Resolving); Vomiting (Recovering / Resolving); Nasopharyngitis (Recovering / Resolving); Diarrhoea (Recovered / Resolved)
|
MEKINIST (Suspect), Active: TRAMETINIB DIMETHYL SULFOXIDE, Dosage: 2 MG, UNK, Indication: MALIGNANT MELANOMA, Action: Dose not changed; TAFINLAR (Suspect), Active: DABRAFENIB MESYLATE, Dosage: 150 MG, UNK, Indication: MALIGNANT MELANOMA, Action: Dose not changed; MEKINIST (Suspect), Active: TRAMETINIB DIMETHYL SULFOXIDE, Indication: METASTASES TO CENTRAL NERVOUS SYSTEM, Action: Dose not changed; TAFINLAR (Suspect), Active: DABRAFENIB MESYLATE, Indication: METASTASES TO CENTRAL NERVOUS SYSTEM, Action: Dose not changed
|
['mekinist', 'tafinlar']
|
['dabrafenib mesylate', 'trametinib dimethyl sulfoxide']
|
['metastases to central nervous system', 'malignant melanoma']
|
14,653,809
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
US-PFIZER INC-2018066807
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Headache (Recovered / Resolved); Body height decreased (Not Recovered / Not Resolved / Ongoing); Abdominal pain upper (Recovered / Resolved); Pain in extremity (Not Recovered / Not Resolved / Ongoing); Nausea (Recovered / Resolved); Joint swelling (Not Recovered / Not Resolved / Ongoing); Muscle twitching (Recovered / Resolved); Ear pain (Recovered / Resolved); Peripheral swelling (Not Recovered / Not Resolved / Ongoing)
|
XELJANZ XR (Suspect), Active: TOFACITINIB CITRATE, Dosage: UNK, Action: Drug Withdrawn, Additional: Yes; XELJANZ XR (Suspect), Active: TOFACITINIB CITRATE, Dosage: 11 MG, 1X/DAY, Action: Drug Withdrawn, Additional: Yes; XELJANZ XR (Suspect), Active: TOFACITINIB CITRATE, Dosage: 11 MG, 1X/DAY, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['xeljanz xr']
|
['tofacitinib citrate']
|
['rheumatoid arthritis']
|
14,657,081
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
US-ACTELION-A-NJ2018-169071
|
Regulatory Authority
|
FDA-Public Use
| 80
|
Year
|
Female
|
Middle ear effusion (Not Recovered / Not Resolved / Ongoing); Deafness unilateral (Not Recovered / Not Resolved / Ongoing)
|
OPSUMIT (Suspect), Active: MACITENTAN, Dosage: 10 MG, QD, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Dose not changed
|
['opsumit']
|
['macitentan']
|
['pulmonary arterial hypertension']
|
14,661,348
| 2
|
Canada
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
CA-TAKEDA-2018TUS006443
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Male
|
Mouth ulceration (Recovering / Resolving)
|
VEDOLIZUMAB (Suspect), Active: VEDOLIZUMAB, Dosage: 300 MG, UNK, Indication: COLITIS ULCERATIVE, Action: Drug Withdrawn, Additional: Yes
|
['vedolizumab']
|
['vedolizumab']
|
['colitis ulcerative']
|
14,663,635
| 7
|
Korea (the Republic of)
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
KR-ROCHE-2087893
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Retinopathy (Recovered / Resolved); Asthenia (Recovered / Resolved)
|
ATEZOLIZUMAB. (Suspect), Active: ATEZOLIZUMAB, Dosage: DATE OF MOST RECENT DOSE OF ATEZOLIZUMAB (840 MG) PRIOR TO THE ADVERSE EVENT: 26/FEB/2018,?MOST RECE, Indication: MALIGNANT MELANOMA, Action: Dose not changed; COBIMETINIB. (Suspect), Active: COBIMETINIB, Dosage: DATE OF MOST RECENT DOSE OF COBIMETINIB (60 MG) PRIOR TO ADVERSE EVENT: 06/MAR/2018, Indication: MALIGNANT MELANOMA, Action: Drug Withdrawn, Additional: Yes; COBIMETINIB. (Suspect), Active: COBIMETINIB, Action: Drug Withdrawn, Additional: Yes
|
['atezolizumab.', 'cobimetinib.']
|
['atezolizumab', 'cobimetinib']
|
['malignant melanoma']
|
14,652,911
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-023613
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Death (Fatal)
|
ELIQUIS (Suspect), Active: APIXABAN, Dosage: 5 MG, BID, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['eliquis']
|
['apixaban']
|
['product used for unknown indication']
|
14,656,127
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-GILEAD-2018-0326173
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Female
|
Cardiac pacemaker insertion (Recovered / Resolved)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 5 MG, QD, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Dose not changed
|
['ambrisentan']
|
['ambrisentan']
|
['pulmonary arterial hypertension']
|
14,656,169
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-ASTRAZENECA-2018SE22244
|
Regulatory Authority
|
FDA-Public Use
| 2,423
|
Week
|
Male
|
Fall (Recovered / Resolved); Wrist fracture (Not Recovered / Not Resolved / Ongoing); Facial bones fracture (Not Recovered / Not Resolved / Ongoing)
|
PULMICORT FLEXHALER (Suspect), Active: BUDESONIDE, Dosage: 180 MCG, TWO PUFFS TWICE A DAY, Indication: ASTHMA, Action: Dose not changed
|
['pulmicort flexhaler']
|
['budesonide']
|
['asthma']
|
14,659,257
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
GB-JNJFOC-20180312997
|
Regulatory Authority
|
FDA-Public Use
| 34
|
Year
|
Male
|
Body temperature increased (Not Recovered / Not Resolved / Ongoing); Heart rate increased (Recovered / Resolved); Urinary tract infection (Recovered / Resolved); Blood pressure increased (Recovered / Resolved); Rash (Not Recovered / Not Resolved / Ongoing); Dyspepsia (Not Recovered / Not Resolved / Ongoing); Pain (Recovered / Resolved); Epididymitis (Recovered / Resolved)
|
PARACETAMOL (Suspect), Active: ACETAMINOPHEN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; PARACETAMOL (Suspect), Active: ACETAMINOPHEN, Action: Unknown, Additional: Doesn't Apply; LEMTRADA (Suspect), Active: ALEMTUZUMAB, Indication: RELAPSING-REMITTING MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['paracetamol', 'lemtrada']
|
['alemtuzumab', 'acetaminophen']
|
['relapsing-remitting multiple sclerosis', 'product used for unknown indication']
|
14,662,949
| 2
|
France
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
FR-SA-2018SA077136
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Male
|
Arrhythmia (Fatal); Hepatocellular injury (Fatal); Hepatic failure (Fatal); Venoocclusive liver disease (Fatal); Transaminases increased (Fatal); Multiple organ dysfunction syndrome (Fatal); Acute kidney injury (Fatal); Intestinal ischaemia (Fatal)
|
OXALIPLATIN. (Suspect), Active: OXALIPLATIN, Dosage: CYCLIC (R-DHAO), Indication: MANTLE CELL LYMPHOMA, Action: Not applicable
|
['oxaliplatin.']
|
['oxaliplatin']
|
['mantle cell lymphoma']
|
14,663,760
| 2
|
Argentina
|
Spontaneous
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
PHHY2012AR025122
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Female
|
Asthenia (Not Recovered / Not Resolved / Ongoing); Dizziness (Not Recovered / Not Resolved / Ongoing); Influenza (Recovered / Resolved); Muscle spasms (Not Recovered / Not Resolved / Ongoing); Hepatitis A (Recovered / Resolved); Diarrhoea (Not Recovered / Not Resolved / Ongoing); Vision blurred (Not Recovered / Not Resolved / Ongoing); Stress (Not Recovered / Not Resolved / Ongoing); Hypotension (Not Recovered / Not Resolved / Ongoing); Feeling abnormal (Not Recovered / Not Resolved / Ongoing)
|
GLIVEC (Suspect), Active: IMATINIB MESYLATE, Dosage: 400 MG, QD, Indication: CHRONIC MYELOID LEUKAEMIA, Action: Dose not changed
|
['glivec']
|
['imatinib mesylate']
|
['chronic myeloid leukaemia']
|
14,652,997
| 3
|
Canada
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
CA-ABBVIE-18K-028-2290641-00
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Fear (Not Recovered / Not Resolved / Ongoing); Injection site pain (Recovered / Resolved); Anxiety (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing); Dizziness (Not Recovered / Not Resolved / Ongoing)
|
CITALOPRAM (Suspect), Active: CITALOPRAM HYDROBROMIDE, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIATIC ARTHROPATHY, Action: Dose not changed; CITALOPRAM (Suspect), Active: CITALOPRAM HYDROBROMIDE, Indication: ANXIETY, Action: Unknown, Additional: Doesn't Apply
|
['citalopram', 'humira']
|
['citalopram hydrobromide', 'adalimumab']
|
['anxiety', 'psoriatic arthropathy']
|
14,654,014
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-APOTEX-2018AP005398
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Male
|
Nervousness (Not Recovered / Not Resolved / Ongoing); Feeling jittery (Not Recovered / Not Resolved / Ongoing)
|
NICOTINE TRANSDERMAL SYSTEM (Suspect), Active: NICOTINE, Dosage: 1 DF, QD, Indication: SMOKING CESSATION THERAPY, Action: Dose not changed
|
['nicotine transdermal system']
|
['nicotine']
|
['smoking cessation therapy']
|
14,656,242
| 2
|
Canada
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
CA-JNJFOC-20180320374
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Male
|
Intestinal obstruction (Recovered / Resolved)
|
STELARA (Suspect), Active: USTEKINUMAB, Dosage: STRENGTH = 90 MG, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['stelara']
|
['ustekinumab']
|
['crohn^s disease']
|
14,658,019
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-014807
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Arterial occlusive disease (Not Recovered / Not Resolved / Ongoing); Urinary tract infection (Recovered / Resolved); Vulvovaginal mycotic infection (Recovered / Resolved); Fatigue (Not Recovered / Not Resolved / Ongoing)
|
JARDIANCE (Suspect), Active: EMPAGLIFLOZIN, Indication: DIABETES MELLITUS, Action: Dose not changed
|
['jardiance']
|
['empagliflozin']
|
['diabetes mellitus']
|
14,658,028
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
US-ABBVIE-18K-163-2284876-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Diffuse large B-cell lymphoma (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: No
|
['humira']
|
['adalimumab']
|
['crohn^s disease']
|
14,659,942
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
US-GILEAD-2018-0326442
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Male
|
Embolic stroke (Recovered / Resolved)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 5 MG, QD, Indication: PULMONARY HYPERTENSION, Action: Dose not changed
|
['ambrisentan']
|
['ambrisentan']
|
['pulmonary hypertension']
|
14,660,776
| 3
|
Israel
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
IL-JNJFOC-20180319621
|
Regulatory Authority
|
FDA-Public Use
| 69
|
Year
|
Female
|
Pleural effusion (Recovered / Resolved)
|
IBRUTINIB (Suspect), Active: IBRUTINIB, Indication: LYMPHOMA, Action: Drug Withdrawn, Additional: Yes
|
['ibrutinib']
|
['ibrutinib']
|
['lymphoma']
|
14,661,456
| 2
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-023491
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Male
|
Mycobacterial infection (Recovered / Resolved)
|
TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: 2 MG, QD, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply; PREDNISOLONE /00016202/ (Suspect), Active: PREDNISOLONE, Dosage: 20 MG, UNK, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply; PREDNISOLONE /00016202/ (Suspect), Active: PREDNISOLONE, Dosage: 17.5 MG, QD, Indication: POLYMYOSITIS, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: 8 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply; ORENCIA (Suspect), Active: ABATACEPT, Dosage: 500 MG, QD, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['methotrexate.', 'tacrolimus.', 'prednisolone /00016202/', 'orencia']
|
['prednisolone', 'tacrolimus', 'methotrexate', 'abatacept']
|
['rheumatoid arthritis', 'polymyositis']
|
14,653,105
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
GB-ABBVIE-18K-167-2290980-00
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Male
|
Fatigue (Not Recovered / Not Resolved / Ongoing)
|
DUODOPA (Suspect), Active: CARBIDOPA\LEVODOPA, Dosage: 100ML CASSETTE, Indication: PARKINSON^S DISEASE, Action: Unknown, Additional: Doesn't Apply; DUODOPA (Suspect), Active: CARBIDOPA\LEVODOPA, Dosage: DOSE INCREASED/100ML CASSETTE, Action: Unknown, Additional: Doesn't Apply
|
['duodopa']
|
['carbidopa\\levodopa']
|
['parkinson^s disease']
|
14,656,305
| 3
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
DE-TAIHO ONCOLOGY INC-JPTT180232
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Male
|
Pneumonitis (Recovered / Resolved); Syncope (Recovered / Resolved)
|
LONSURF (Suspect), Active: TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE, Dosage: 35 MG BID (UNK MG/M2) ON DAYS 1-5 AND 8-12 OF EACH 28-DAY CYCLE, Indication: COLORECTAL CANCER METASTATIC, Action: Dose not changed
|
['lonsurf']
|
['tipiracil hydrochloride\\trifluridine']
|
['colorectal cancer metastatic']
|
14,656,321
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-CELGENEUS-USA-20180303838
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Female
|
IDH differentiation syndrome (Recovered / Resolved)
|
IDHIFA (Suspect), Active: ENASIDENIB MESYLATE, Action: Drug Withdrawn, Additional: Yes; IDHIFA (Suspect), Active: ENASIDENIB MESYLATE, Dosage: 100 MILLIGRAM, Indication: ACUTE MYELOID LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['idhifa']
|
['enasidenib mesylate']
|
['acute myeloid leukaemia']
|
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