safetyreportid int64 3.04M 24.8M | safetyreportversion int64 1 138 | occurcountry stringclasses 233 values | reporttype stringclasses 4 values | serious stringclasses 2 values | serious_specific stringclasses 360 values | receivedate int64 20M 20.2M | transmissiondate int64 20.1M 20.3M | companynumb stringlengths 1 89 ⌀ | sendertype stringclasses 4 values | senderorganization stringclasses 767 values | patientonsetage float64 -6,179 41.9k ⌀ | patientonsetageunit stringclasses 6 values | patientsex stringclasses 3 values | reactions stringlengths 12 9.58k | drugs_specific stringlengths 30 332k ⌀ | drugnames stringlengths 2 4.87k | activesubstancenames stringlengths 2 4.75k | drugindications stringlengths 2 999 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 (Suspect), Active: TICAGRELOR, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No; RANOLAZINE. (Suspect), Active: RANOLAZINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No | ['ticagrelor.', 'ranolazine.']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'] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.