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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
14,669,190
| 3
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
JP-BAYER-2018-050790
|
Regulatory Authority
|
FDA-Public Use
| 79
|
Year
|
Male
|
Cancer pain (Not Recovered / Not Resolved / Ongoing)
|
XOFIGO (Suspect), Active: RADIUM RA-223 DICHLORIDE, Dosage: 55KBQ/KG, Q1MON, Indication: METASTASES TO BONE, Action: Unknown; XOFIGO (Suspect), Active: RADIUM RA-223 DICHLORIDE, Dosage: 55KBQ/KG, Q1MON, Indication: HORMONE-REFRACTORY PROSTATE CANCER, Action: Unknown
|
['xofigo']
|
['radium ra-223 dichloride']
|
['hormone-refractory prostate cancer', 'metastases to bone']
|
14,669,202
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
US-JNJFOC-20180325173
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Female
|
Diarrhoea (Recovered / Resolved); Acute kidney injury (Recovering / Resolving); Urinary tract infection (Recovering / Resolving); Dehydration (Recovering / Resolving)
|
JANUVIA (Suspect), Active: SITAGLIPTIN PHOSPHATE, Indication: TYPE 2 DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply; METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: TYPE 2 DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply; INVOKANA (Suspect), Active: CANAGLIFLOZIN, Dosage: 100 AND 300 MG, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes
|
['invokana', 'januvia', 'metformin']
|
['canagliflozin', 'sitagliptin phosphate', 'metformin hydrochloride']
|
['type 2 diabetes mellitus']
|
14,673,615
| 2
|
Netherlands
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
PHHY2018NL051421
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Male
|
Malaise (Recovering / Resolving)
|
SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 20 MG, (20MG/2ML) Q3W, Action: Dose not changed; SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 20 MG, (20MG/2ML) Q3W, Indication: DYSPEPSIA, Action: Dose not changed
|
['sandostatin lar depot']
|
['octreotide acetate']
|
['dyspepsia']
|
14,675,803
| 4
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
DE-PFIZER INC-2018118481
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Female
|
Neoplasm progression (Fatal); Upper gastrointestinal haemorrhage (Fatal); Bradycardia (Fatal); Disease recurrence (Fatal); Drug ineffective (Fatal); Septic shock (Fatal); Respiratory failure (Fatal); Shock (Fatal)
|
SUNITINIB MALATE. (Suspect), Active: SUNITINIB MALATE, Dosage: UNK, 2ND LINE THERAPY, Indication: GASTROINTESTINAL STROMAL TUMOUR, Action: Not applicable; AMIODARONE HCL (Suspect), Active: AMIODARONE HYDROCHLORIDE, Dosage: UNK, Indication: ATRIAL FIBRILLATION, Action: Not applicable; IMATINIB (Suspect), Active: IMATINIB, Dosage: 400 MG/DAY AS 1ST LINE ADJUVANT THERAPY, Indication: GASTROINTESTINAL STROMAL TUMOUR, Action: Not applicable; DIGOXIN. (Suspect), Active: DIGOXIN, Dosage: UNK, Indication: ATRIAL FIBRILLATION, Action: Not applicable
|
['digoxin.', 'amiodarone hcl', 'imatinib', 'sunitinib malate.']
|
['sunitinib malate', 'digoxin', 'imatinib', 'amiodarone hydrochloride']
|
['atrial fibrillation', 'gastrointestinal stromal tumour']
|
14,675,854
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
US-JNJFOC-20180331499
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Male
|
Pneumonia (Fatal); Opportunistic infection (Fatal)
|
IMBRUVICA (Suspect), Active: IBRUTINIB, Indication: MANTLE CELL LYMPHOMA, Action: Drug Withdrawn
|
['imbruvica']
|
['ibrutinib']
|
['mantle cell lymphoma']
|
14,664,343
| 2
|
Philippines
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
PH-REGENERON PHARMACEUTICALS, INC.-2018-18768
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Vitreous haemorrhage (Recovered / Resolved)
|
EYLEA (Suspect), Active: AFLIBERCEPT, Dosage: FIRST AND ONLY DOSE, Indication: POLYPOIDAL CHOROIDAL VASCULOPATHY, Action: Drug Withdrawn, Additional: Yes
|
['eylea']
|
['aflibercept']
|
['polypoidal choroidal vasculopathy']
|
14,665,064
| 2
|
Israel
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
IL-JNJFOC-20180324683
|
Regulatory Authority
|
FDA-Public Use
| 53
|
Year
|
Male
|
Headache (Recovered / Resolved); Hypotension (Recovered / Resolved); Asthenia (Recovered / Resolved); Headache (Recovered / Resolved); Thrombectomy (Recovered / Resolved); Headache (Recovered / Resolved); Dizziness (Recovered / Resolved); Exercise tolerance decreased (Recovered / Resolved); Dyspnoea exertional (Recovered / Resolved); Muscular weakness (Recovered / Resolved); Abdominal pain (Recovered / Resolved)
|
SYMBICORT (Suspect), Active: BUDESONIDE\FORMOTEROL FUMARATE DIHYDRATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; XARELTO (Suspect), Active: RIVAROXABAN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; ADEMPAS (Suspect), Active: RIOCIGUAT, Indication: PULMONARY HYPERTENSION, Action: Unknown, Additional: Doesn't Apply
|
['adempas', 'symbicort', 'xarelto']
|
['riociguat', 'budesonide\\formoterol fumarate dihydrate', 'rivaroxaban']
|
['product used for unknown indication', 'pulmonary hypertension']
|
14,668,497
| 2
|
France
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
FR-PFIZER INC-2018113170
|
Regulatory Authority
|
FDA-Public Use
| 13
|
Year
|
Male
|
Hepatocellular injury (Recovered / Resolved)
|
VINCRISTINE SULFATE. (Suspect), Active: VINCRISTINE SULFATE, Dosage: 2 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; 6-MERCAPTOPURINE MONOHYDRATE (Suspect), Active: MERCAPTOPURINE, Dosage: 100 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Dosage: 15 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; CYTARABINE. (Suspect), Active: CYTARABINE, Dosage: 125 MG, UNK, Action: Unknown, Additional: Doesn't Apply; ONCASPAR (Suspect), Active: PEGASPARGASE, Dosage: 4050 IU, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; HYDROCORTISONE. (Suspect), Active: HYDROCORTISONE, Dosage: 15 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: 1600 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; CYTARABINE. (Suspect), Active: CYTARABINE, Dosage: 30 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['cyclophosphamide.', 'vincristine sulfate.', 'oncaspar', 'methotrexate sodium.', '6-mercaptopurine monohydrate', 'cytarabine.', 'hydrocortisone.']
|
['hydrocortisone', 'pegaspargase', 'methotrexate sodium', 'vincristine sulfate', 'cyclophosphamide', 'mercaptopurine', 'cytarabine']
|
['acute lymphocytic leukaemia']
|
14,670,750
| 2
|
Ireland
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
IE-SHIRE-IE201811225
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Death (Fatal)
|
ELAPRASE (Suspect), Active: IDURSULFASE, Dosage: 12 MG, 1X/WEEK, Indication: MUCOPOLYSACCHARIDOSIS II, Action: Not applicable
|
['elaprase']
|
['idursulfase']
|
['mucopolysaccharidosis ii']
|
14,672,991
| 2
|
Italy
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
IT-AUROBINDO-AUR-APL-2018-016239
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Male
|
Rhabdomyolysis (Recovering / Resolving)
|
PANTOPRAZOLE (Suspect), Active: PANTOPRAZOLE, Dosage: 40 MILLIGRAM, DAILY, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; LEVOFLOXACIN. (Suspect), Active: LEVOFLOXACIN, Dosage: 500 MILLIGRAM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable; SIMVASTATIN TABLET (Suspect), Active: SIMVASTATIN, Dosage: 10 MILLIGRAM, DAILY, Indication: DYSLIPIDAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['pantoprazole', 'levofloxacin.', 'simvastatin tablet']
|
['simvastatin', 'pantoprazole', 'levofloxacin']
|
['product used for unknown indication', 'dyslipidaemia']
|
14,668,592
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-DRREDDYS-USA/USA/18/0096898
|
Regulatory Authority
|
FDA-Public Use
| 29
|
Year
|
Female
|
Nodular melanoma (Recovered / Resolved)
|
TACROLIMUS. (Suspect), Active: TACROLIMUS, Indication: PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Indication: PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE, Action: Not applicable; BUSULFAN. (Suspect), Active: BUSULFAN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable; FLUDARABINE (Suspect), Active: FLUDARABINE PHOSPHATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['tacrolimus.', 'busulfan.', 'methotrexate.', 'fludarabine']
|
['fludarabine phosphate', 'tacrolimus', 'methotrexate', 'busulfan']
|
['prophylaxis against graft versus host disease', 'product used for unknown indication']
|
14,668,664
| 2
|
France
|
Other
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
FR-APOTEX-2018AP008605
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Eosinophilic pleural effusion (Recovered / Resolved)
|
PAROXETINE TABLET (Suspect), Active: PAROXETINE, Dosage: 20 MG, UNK, Action: Drug Withdrawn, Additional: Yes; XEROQUEL (Suspect), Active: QUETIAPINE FUMARATE, Dosage: 1 DF, UNK, Indication: BIPOLAR DISORDER, Action: Unknown, Additional: Doesn't Apply; DEPAMIDE (Suspect), Active: VALPROMIDE, Dosage: 1 DF, UNK, Indication: BIPOLAR DISORDER, Action: Unknown, Additional: Doesn't Apply
|
['paroxetine tablet', 'xeroquel', 'depamide']
|
['paroxetine', 'quetiapine fumarate', 'valpromide']
|
['bipolar disorder']
|
14,670,137
| 2
|
Russian Federation
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
RU-NOVOPROD-590947
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Myocardial infarction (Recovered / Resolved with Sequelae); Pneumonia (Recovered / Resolved)
|
NOVORAPID (Suspect), Active: INSULIN ASPART, Dosage: U QD, Indication: TYPE 1 DIABETES MELLITUS, Action: Dose not changed
|
['novorapid']
|
['insulin aspart']
|
['type 1 diabetes mellitus']
|
14,670,777
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
US-ACTELION-A-NJ2018-169624
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Female
|
Death (Fatal)
|
VELETRI (Suspect), Active: EPOPROSTENOL, Dosage: 40 NG/KG, PER MIN, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Unknown, Additional: Doesn't Apply
|
['veletri']
|
['epoprostenol']
|
['pulmonary arterial hypertension']
|
14,675,994
| 2
|
Germany
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-025497
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Post procedural haemorrhage (Recovered / Resolved); Tooth fracture (Recovered / Resolved)
|
ELIQUIS (Suspect), Active: APIXABAN, Dosage: 2.5 MG, BID, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; ELIQUIS (Suspect), Active: APIXABAN, Dosage: 5 MG, BID, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Dose not changed
|
['eliquis']
|
['apixaban']
|
['cerebrovascular accident prophylaxis', 'product used for unknown indication']
|
14,665,260
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,321
| 20,180,711
|
US-ASTRAZENECA-2018SE33523
|
Regulatory Authority
|
FDA-Public Use
| 164
|
Day
|
Male
|
Drug dose omission (Recovered / Resolved)
|
SYNAGIS (Suspect), Active: PALIVIZUMAB, Indication: PREMATURE BABY, Action: Dose not changed
|
['synagis']
|
['palivizumab']
|
['premature baby']
|
14,665,276
| 3
|
Germany
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-010612
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Male
|
Lipase increased (Not Recovered / Not Resolved / Ongoing); Death (Fatal)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, Q2WK, Indication: NON-SMALL CELL LUNG CANCER, Action: Dose not changed
|
['nivolumab']
|
['nivolumab']
|
['non-small cell lung cancer']
|
14,667,000
| 3
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
JP-TAKEDA-2018TJP007856
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Pneumonia (Recovered / Resolved)
|
NINLARO (Suspect), Active: IXAZOMIB CITRATE, Dosage: 2.3 MG, UNK, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes
|
['ninlaro']
|
['ixazomib citrate']
|
['plasma cell myeloma']
|
14,669,344
| 2
|
Spain
|
Report from study
|
No
| null | 20,180,322
| 20,180,711
|
ES-JNJFOC-20180317967
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Gingival bleeding (Recovered / Resolved); Dizziness (Not Recovered / Not Resolved / Ongoing); Contusion (Recovered / Resolved)
|
IMBRUVICA (Suspect), Active: IBRUTINIB, Indication: CHRONIC LYMPHOCYTIC LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['imbruvica']
|
['ibrutinib']
|
['chronic lymphocytic leukaemia']
|
14,671,871
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,323
| 20,180,711
|
US-AMGEN-USASP2018039378
|
Regulatory Authority
|
FDA-Public Use
| 44
|
Year
|
Female
|
Influenza (Recovered / Resolved); Bone pain (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: PSORIASIS, Action: Unknown, Additional: Doesn't Apply; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Action: Unknown, Additional: Doesn't Apply
|
['enbrel']
|
['etanercept']
|
['psoriasis']
|
14,665,338
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
US-AKORN PHARMACEUTICALS-2018AKN00319
|
Regulatory Authority
|
FDA-Public Use
| 17
|
Year
|
Female
|
Depressed mood (Recovered / Resolved); Off label use (Recovered / Resolved)
|
MYORISAN (Suspect), Active: ISOTRETINOIN, Dosage: 30 MG, 2X/DAY, Action: Drug Withdrawn, Additional: Yes; MYORISAN (Suspect), Active: ISOTRETINOIN, Dosage: 30 MG, 1X/DAY, Indication: ACNE, Action: Drug Withdrawn, Additional: Yes
|
['myorisan']
|
['isotretinoin']
|
['acne']
|
14,665,346
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes)
| 20,180,321
| 20,180,711
|
US-PFIZER INC-2018114042
|
Regulatory Authority
|
FDA-Public Use
| 79
|
Year
|
Male
|
Myocardial infarction (Fatal)
|
DINUTUXIMAB (Suspect), Active: DINUTUXIMAB, Dosage: UNK, Action: Not applicable; IRINOTECAN HCL (Suspect), Active: IRINOTECAN HYDROCHLORIDE, Dosage: UNK, Action: Not applicable; IRINOTECAN HCL (Suspect), Active: IRINOTECAN HYDROCHLORIDE, Dosage: 388 MG, TOTAL DAILY DOSE, Indication: SMALL CELL LUNG CANCER, Action: Not applicable; DINUTUXIMAB (Suspect), Active: DINUTUXIMAB, Dosage: 34 MG, TOTAL DAILY DOSE, Indication: SMALL CELL LUNG CANCER, Action: Not applicable
|
['dinutuximab', 'irinotecan hcl']
|
['irinotecan hydrochloride', 'dinutuximab']
|
['small cell lung cancer']
|
14,666,101
| 2
|
Italy
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,321
| 20,180,711
|
PHHY2018IT040699
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Cardiac failure congestive (Fatal)
|
PREDNISONE. (Suspect), Active: PREDNISONE, Dosage: 100 MG, QD, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Not applicable; VINCRISTINE (Suspect), Active: VINCRISTINE, Dosage: 1.4 MG/M2, DAY 1 UNK, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Not applicable; MYOCET (Suspect), Active: DOXORUBICIN, Dosage: 50 MG/M2, DAY 1 UNK, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Not applicable; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: 750 MG/M2, DAY 1, UNK, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Not applicable; MABTHERA (Suspect), Active: RITUXIMAB, Dosage: 375 MG/M2, DAY 3 OF CYCLE 1 AND DAY 1 OF SUBSEQUENT CYCLES UNK, Indication: DIFFUSE LARGE B-CELL LYMPHOMA, Action: Not applicable
|
['cyclophosphamide.', 'vincristine', 'mabthera', 'myocet', 'prednisone.']
|
['vincristine', 'doxorubicin', 'rituximab', 'cyclophosphamide', 'prednisone']
|
['diffuse large b-cell lymphoma']
|
14,667,054
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
US-009507513-1803USA009093
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Dyspnoea (Not Recovered / Not Resolved / Ongoing); Cough (Not Recovered / Not Resolved / Ongoing)
|
DULERA (Suspect), Active: FORMOTEROL FUMARATE DIHYDRATE\MOMETASONE FUROATE, Dosage: 2 DF, UNK, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Drug Withdrawn, Additional: No; DULERA (Suspect), Active: FORMOTEROL FUMARATE DIHYDRATE\MOMETASONE FUROATE, Dosage: 2 PUFFS TWICE PER DAY, BID, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Not applicable
|
['dulera']
|
['formoterol fumarate dihydrate\\mometasone furoate']
|
['chronic obstructive pulmonary disease']
|
14,673,131
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
JP-ASTELLAS-2018JP004535AA
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Male
|
Still^s disease (Recovering / Resolving)
|
PROGRAF (Suspect), Active: TACROLIMUS\TACROLIMUS ANHYDROUS, Indication: STILL^S DISEASE, Action: Drug Withdrawn, Additional: Yes; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Dosage: UNK UNK, UNKNOWN FREQ., Indication: STILL^S DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['prednisolone.', 'prograf']
|
['prednisolone', 'tacrolimus\\tacrolimus anhydrous']
|
['still^s disease']
|
14,674,647
| 2
|
Canada
|
Other
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
CA-APOTEX-2018AP008074
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Adverse drug reaction (Not Recovered / Not Resolved / Ongoing); Emotional disorder (Not Recovered / Not Resolved / Ongoing); Depression (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing)
|
ESCITALOPRAM (Suspect), Active: ESCITALOPRAM OXALATE, Dosage: 10 MG, QD, Indication: DEPRESSION, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: 40 MG, Q.WK., Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['escitalopram', 'humira']
|
['escitalopram oxalate', 'adalimumab']
|
['crohn^s disease', 'depression']
|
14,676,105
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
US-ELI_LILLY_AND_COMPANY-US201803006471
|
Regulatory Authority
|
FDA-Public Use
| 87
|
Year
|
Female
|
Myocardial infarction (Recovered / Resolved); Contrast media allergy (Recovered / Resolved)
|
SPIRIVA (Suspect), Active: TIOTROPIUM BROMIDE MONOHYDRATE, Dosage: UNK UNK, UNKNOWN, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Unknown, Additional: Doesn't Apply; ADCIRCA (Suspect), Active: TADALAFIL, Dosage: 20 MG, UNKNOWN, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Unknown, Additional: Doesn't Apply
|
['adcirca', 'spiriva']
|
['tadalafil', 'tiotropium bromide monohydrate']
|
['pulmonary arterial hypertension', 'chronic obstructive pulmonary disease']
|
14,676,122
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-PRINSTON PHARMACEUTICAL INC.-2018PRN00119
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Headache (Recovering / Resolving); Blood pressure increased (Recovering / Resolving); Blood pressure fluctuation (Recovering / Resolving); Drug ineffective (Recovering / Resolving)
|
LISINOPRIL. (Suspect), Active: LISINOPRIL, Dosage: 5 MG, 2X/DAY, Indication: HYPERTENSION, Action: Dose Increased; LISINOPRIL. (Suspect), Active: LISINOPRIL, Dosage: 5 MG, 2X/DAY, Indication: HYPERTENSION, Action: Not applicable
|
['lisinopril.']
|
['lisinopril']
|
['hypertension']
|
14,666,129
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,321
| 20,180,711
|
US-ELI_LILLY_AND_COMPANY-US201803006970
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Blood glucose increased (Recovered / Resolved); Drug dose omission (Recovered / Resolved); Blood glucose increased (Recovered / Resolved)
|
INSULIN, LISPRO (Suspect), Active: INSULIN LISPRO, Dosage: 16 U, EACH EVENING(AT DINNER), Action: Drug Withdrawn, Additional: Yes; INSULIN, LISPRO (Suspect), Active: INSULIN LISPRO, Dosage: 14 U, EACH MORNING(AT BREAKFAST), Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes
|
['insulin, lispro']
|
['insulin lispro']
|
['type 2 diabetes mellitus']
|
14,667,860
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
GB-ROCHE-2089776
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Female
|
Alanine aminotransferase increased (Recovered / Resolved)
|
ROACTEMRA (Suspect), Active: TOCILIZUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['roactemra']
|
['tocilizumab']
|
['rheumatoid arthritis']
|
14,670,222
| 2
|
France
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
FR-BAUSCH-BL-2018-006654
|
Regulatory Authority
|
FDA-Public Use
| 6
|
Year
|
Male
|
Cholestasis (Recovered / Resolved)
|
VINCRISTINE (Suspect), Active: VINCRISTINE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Action: Not applicable; ONCASPAR (Suspect), Active: PEGASPARGASE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Not applicable; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: 22 MG, ONE DOSE, Action: Unknown, Additional: Doesn't Apply; 6-MERCAPTOPURINE MONOHYDRATE (Suspect), Active: MERCAPTOPURINE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['vincristine', 'methotrexate.', 'oncaspar', 'dexamethasone.', '6-mercaptopurine monohydrate']
|
['vincristine', 'pegaspargase', 'mercaptopurine', 'methotrexate', 'dexamethasone']
|
['acute lymphocytic leukaemia']
|
14,675,411
| 2
|
Colombia
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
PHHY2018CO043993
|
Regulatory Authority
|
FDA-Public Use
| 5
|
Year
|
Female
|
Headache (Not Recovered / Not Resolved / Ongoing)
|
OMNITROPE (Suspect), Active: SOMATROPIN, Indication: PITUITARY TUMOUR, Action: Not applicable; OMNITROPE (Suspect), Active: SOMATROPIN, Dosage: 0.5 MG, QD, Indication: GROWTH HORMONE DEFICIENCY, Action: Not applicable
|
['omnitrope']
|
['somatropin']
|
['growth hormone deficiency', 'pituitary tumour']
|
14,665,397
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
US-DRREDDYS-USA/USA/18/0096863
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Male
|
Blood creatine increased (Recovered / Resolved); Toxic optic neuropathy (Recovered / Resolved); Pupillary reflex impaired (Recovered / Resolved); Blindness (Recovered / Resolved)
|
TACROLIMUS. (Suspect), Active: TACROLIMUS, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; TACROLIMUS. (Suspect), Active: TACROLIMUS, Action: Drug Withdrawn, Additional: Yes; MELPHALAN. (Suspect), Active: MELPHALAN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; PREDNISONE. (Suspect), Active: PREDNISONE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown
|
['tacrolimus.', 'prednisone.', 'melphalan.']
|
['tacrolimus', 'prednisone', 'melphalan']
|
['product used for unknown indication']
|
14,667,176
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-HORIZON-KRY-0070-2018
|
Regulatory Authority
|
FDA-Public Use
| 43
|
Year
|
Male
|
Infusion related reaction (Recovered / Resolved)
|
KRYSTEXXA (Suspect), Active: PEGLOTICASE, Dosage: 8 MG EVERY 2 WEEKS, Indication: GOUT, Action: Drug Withdrawn, Additional: Yes
|
['krystexxa']
|
['pegloticase']
|
['gout']
|
14,667,886
| 2
|
India
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
PHHY2016IN165247
|
Regulatory Authority
|
FDA-Public Use
| 79
|
Year
|
Male
|
Death (Fatal)
|
GLIVEC (Suspect), Active: IMATINIB MESYLATE, Dosage: 400 MG, UNK, Indication: CHRONIC MYELOID LEUKAEMIA, Action: Not applicable; GLIVEC (Suspect), Active: IMATINIB MESYLATE, Dosage: 300 MG, UNK, Action: Not applicable
|
['glivec']
|
['imatinib mesylate']
|
['chronic myeloid leukaemia']
|
14,670,292
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
US-TEVA-2018-US-873048
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Female
|
Pancreatitis (Recovered / Resolved); Metabolic acidosis (Recovered / Resolved)
|
EMPAGLIFLOZIN (Suspect), Active: EMPAGLIFLOZIN, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes; METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes; FUROSEMIDE. (Suspect), Active: FUROSEMIDE, Indication: PERIPHERAL SWELLING, Action: Drug Withdrawn, Additional: Yes
|
['furosemide.', 'metformin', 'empagliflozin']
|
['furosemide', 'metformin hydrochloride', 'empagliflozin']
|
['type 2 diabetes mellitus', 'peripheral swelling']
|
14,673,194
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-TESARO, INC.-US-2018TSO01268
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Pneumonia (Recovered / Resolved); Influenza (Recovered / Resolved); Nasopharyngitis (Recovered / Resolved); Nausea (Recovered / Resolved); Insomnia (Recovered / Resolved); Drug dose omission (Recovered / Resolved); Bronchitis (Recovered / Resolved); White blood cell count decreased (Not Recovered / Not Resolved / Ongoing); Memory impairment (Recovered / Resolved)
|
ZEJULA (Suspect), Active: NIRAPARIB, Dosage: 300 MG, QD, Indication: OVARIAN CANCER, Action: Dose not changed
|
['zejula']
|
['niraparib']
|
['ovarian cancer']
|
14,673,197
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
US-GILEAD-2018-0321591
|
Regulatory Authority
|
FDA-Public Use
| 43
|
Year
|
Female
|
Neck pain (Not Recovered / Not Resolved / Ongoing); Headache (Not Recovered / Not Resolved / Ongoing); Pain in jaw (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Recovering / Resolving)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 10 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed
|
['ambrisentan']
|
['ambrisentan']
|
['product used for unknown indication']
|
14,674,754
| 2
|
Taiwan (Province of China)
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
TW-JNJFOC-20180329108
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Tonsillitis (Recovered / Resolved)
|
SIMPONI (Suspect), Active: GOLIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['simponi']
|
['golimumab']
|
['rheumatoid arthritis']
|
14,675,448
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-BAYER-2017-014062
|
Regulatory Authority
|
FDA-Public Use
| 28
|
Year
|
Female
|
Dysmenorrhoea (Not Recovered / Not Resolved / Ongoing); Migraine (Not Recovered / Not Resolved / Ongoing); Menorrhagia (Not Recovered / Not Resolved / Ongoing); Genital haemorrhage (Not Recovered / Not Resolved / Ongoing); Pelvic pain (Not Recovered / Not Resolved / Ongoing); Dyspareunia (Not Recovered / Not Resolved / Ongoing); Back pain (Not Recovered / Not Resolved / Ongoing); Hypersensitivity (Not Recovered / Not Resolved / Ongoing)
|
MIRENA (Suspect), Active: LEVONORGESTREL, Action: Drug Withdrawn, Additional: No; MIRENA (Suspect), Active: LEVONORGESTREL, Dosage: 20 MCG/24HR, CONT, Action: Drug Withdrawn, Additional: No; ESSURE (ESS205) (Suspect), Active: DEVICE, Dosage: UNK, Indication: FEMALE STERILISATION, Action: Dose not changed
|
['essure (ess205)', 'mirena']
|
['device', 'levonorgestrel']
|
['female sterilisation']
|
14,667,259
| 5
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-AMGEN-USASP2018037767
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Cough (Recovering / Resolving); Muscle spasms (Not Recovered / Not Resolved / Ongoing); Nasopharyngitis (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Action: Drug Withdrawn, Additional: Yes; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
14,668,782
| 4
|
United States of America
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
US-ALKERMES INC.-ALK-2018-001429
|
Regulatory Authority
|
FDA-Public Use
| 39
|
Year
|
Male
|
Hallucination, auditory (Not Recovered / Not Resolved / Ongoing)
|
ARISTADA (Suspect), Active: ARIPIPRAZOLE LAUROXIL, Dosage: 882 MG, QMO, Indication: SCHIZOPHRENIA, Action: Drug Withdrawn, Additional: No; ARISTADA (Suspect), Active: ARIPIPRAZOLE LAUROXIL, Dosage: 882 MG, QMO, Action: Drug Withdrawn, Additional: No
|
['aristada']
|
['aripiprazole lauroxil']
|
['schizophrenia']
|
14,671,153
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
JP-TAKEDA-2018TJP007831AA
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Male
|
Pneumonia (Recovered / Resolved)
|
DECADRON (Suspect), Active: DEXAMETHASONE, Dosage: UNK, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; NINLARO (Suspect), Active: IXAZOMIB CITRATE, Dosage: 4 MG, UNK, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; NINLARO (Suspect), Active: IXAZOMIB CITRATE, Dosage: 4 MG, UNK, Action: Drug Withdrawn, Additional: Yes
|
['ninlaro', 'decadron']
|
['dexamethasone', 'ixazomib citrate']
|
['plasma cell myeloma']
|
14,671,190
| 4
|
Germany
|
Report from study
|
Yes
|
Death (Yes)
| 20,180,322
| 20,180,711
|
DE-ABBVIE-18K-062-2296751-00
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Pulmonary embolism (Fatal)
|
COSENTYX (Suspect), Active: SECUKINUMAB, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIASIS, Action: Not applicable; METEX (METFORMIN HYDROCHLORIDE) (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['metex (metformin hydrochloride)', 'humira', 'cosentyx']
|
['secukinumab', 'metformin hydrochloride', 'adalimumab']
|
['psoriasis', 'product used for unknown indication']
|
14,672,056
| 2
|
Denmark
|
Spontaneous
|
Yes
|
Disabling (Yes)
| 20,180,323
| 20,180,711
|
DK-KADMON PHARMACEUTICALS, LLC-KAD-201803-01267
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Male
|
Vitrectomy (Recovered / Resolved); Vitreous haemorrhage (Recovered / Resolved with Sequelae)
|
EXVIERA 250 MG (Suspect), Active: DASABUVIR, Dosage: ONE TABLET AT 8 AM AND ONE TABLET AT 5 PM, Indication: HEPATITIS C, Action: Drug Withdrawn, Additional: Yes; RIBAVIRIN 200 MG (Suspect), Active: RIBAVIRIN, Dosage: TABLET, Indication: CHRONIC HEPATITIS C, Action: Drug Withdrawn, Additional: Yes; VIEKIRAX 12.5 MG/75 MG/50 MG (Suspect), Active: OMBITASVIR\PARITAPREVIR\RITONAVIR, Dosage: TABLET, Indication: CHRONIC HEPATITIS C, Action: Drug Withdrawn, Additional: Yes
|
['viekirax 12.5 mg/75 mg/50 mg', 'exviera 250 mg', 'ribavirin 200 mg']
|
['ombitasvir\\paritaprevir\\ritonavir', 'dasabuvir', 'ribavirin']
|
['chronic hepatitis c', 'hepatitis c']
|
14,672,071
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
US-009507513-1803USA009358
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Male
|
Arthralgia (Not Recovered / Not Resolved / Ongoing); Hyperaesthesia (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing); Middle insomnia (Not Recovered / Not Resolved / Ongoing); Paraesthesia (Not Recovered / Not Resolved / Ongoing); Hallucination (Recovered / Resolved); Gait disturbance (Not Recovered / Not Resolved / Ongoing)
|
SINGULAIR (Suspect), Active: MONTELUKAST SODIUM, Dosage: 1 DF, QD, Indication: RHINITIS, Action: Dose not changed
|
['singulair']
|
['montelukast sodium']
|
['rhinitis']
|
14,672,748
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
US-ASTELLAS-2018US014302
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Male
|
Myocardial infarction (Fatal)
|
ENZALUTAMIDE (Suspect), Active: ENZALUTAMIDE, Indication: PROSTATE CANCER, Action: Not applicable
|
['enzalutamide']
|
['enzalutamide']
|
['prostate cancer']
|
14,674,147
| 2
|
Canada
|
Other
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
CA-APOTEX-2018AP008263
|
Regulatory Authority
|
FDA-Public Use
| 37
|
Year
|
Male
|
Weight decreased (Recovered / Resolved); Abdominal pain upper (Recovered / Resolved); Incorrect dose administered (Recovered / Resolved); Gastrooesophageal reflux disease (Recovered / Resolved); Nasopharyngitis (Recovered / Resolved); Productive cough (Recovered / Resolved)
|
ACTEMRA (Suspect), Active: TOCILIZUMAB, Dosage: 536 MG, ONCE EVERY 4 WEEKS, Action: Unknown, Additional: Doesn't Apply; ROSUVASTATIN. (Suspect), Active: ROSUVASTATIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; ACTEMRA (Suspect), Active: TOCILIZUMAB, Dosage: 584 MG, ONCE EVERY 4 WEEKS, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['actemra', 'rosuvastatin.']
|
['tocilizumab', 'rosuvastatin']
|
['rheumatoid arthritis', 'product used for unknown indication']
|
14,664,628
| 2
|
Italy
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
IT-PFIZER INC-2018109547
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Hepatitis C (Recovering / Resolving)
|
MELPHALAN. (Suspect), Active: MELPHALAN, Dosage: 9 MG/M2, UNK (ON DAYS 1-4), Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Dosage: 60 MG/M2, (ON DAYS 1-4), Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; DEXAMETHASONE SODIUM PHOSPHATE. (Suspect), Active: DEXAMETHASONE SODIUM PHOSPHATE, Dosage: 20 MG, WEEKLY (AS A ONCE WEEKLY ADMINISTRATION), Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; BORTEZOMIB (Suspect), Active: BORTEZOMIB, Dosage: 1.3 MG/M2, UNK (ON DAYS 1, 8, 15, 22), Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; LENALIDOMIDE (Suspect), Active: LENALIDOMIDE, Dosage: 15 MG, WEEKLY (ONCE-WEEKLY ADMINISTRATION), Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply
|
['lenalidomide', 'methylprednisolone.', 'bortezomib', 'melphalan.', 'dexamethasone sodium phosphate.']
|
['methylprednisolone', 'lenalidomide', 'bortezomib', 'dexamethasone sodium phosphate', 'melphalan']
|
['plasma cell myeloma']
|
14,665,486
| 2
|
France
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
FR-AMGEN-FRACT2018034549
|
Regulatory Authority
|
FDA-Public Use
| 47
|
Year
|
Female
|
Constipation (Recovered / Resolved); Nausea (Recovered / Resolved); Vomiting (Recovered / Resolved); Faecaloma (Recovered / Resolved); General physical health deterioration (Fatal); Tachycardia (Recovered / Resolved); Stomatitis (Recovered / Resolved); Rash (Recovered / Resolved); Diarrhoea (Recovered / Resolved)
|
XGEVA (Suspect), Active: DENOSUMAB, Indication: PANCREATIC CARCINOMA, Action: Dose not changed; XGEVA (Suspect), Active: DENOSUMAB, Dosage: 120 MG, Q4WK, Indication: PANCREATIC NEUROENDOCRINE TUMOUR METASTATIC, Action: Dose not changed; SOMATULINE LP (Suspect), Active: LANREOTIDE ACETATE, Dosage: 120 MG, Q4WK, Indication: PANCREATIC NEUROENDOCRINE TUMOUR METASTATIC, Action: Unknown; AFINITOR (Suspect), Active: EVEROLIMUS, Indication: PANCREATIC CARCINOMA, Action: Unknown; AFINITOR (Suspect), Active: EVEROLIMUS, Dosage: 10 MG, QD, Indication: PANCREATIC NEUROENDOCRINE TUMOUR METASTATIC, Action: Unknown; SUTENT (Suspect), Active: SUNITINIB MALATE, Indication: PANCREATIC CARCINOMA, Action: Drug Withdrawn, Additional: Yes; TEMODAL (Suspect), Active: TEMOZOLOMIDE, Dosage: 210 MG/M2, QD, Indication: PANCREATIC CARCINOMA, Action: Unknown; XELODA (Suspect), Active: CAPECITABINE, Dosage: 800 MG/M2, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown; SUTENT (Suspect), Active: SUNITINIB MALATE, Dosage: 37.5 MG, QD, Indication: PANCREATIC NEUROENDOCRINE TUMOUR METASTATIC, Action: Drug Withdrawn, Additional: Yes; SOMATULINE LP (Suspect), Active: LANREOTIDE ACETATE, Indication: PANCREATIC CARCINOMA, Action: Unknown; TEMODAL (Suspect), Active: TEMOZOLOMIDE, Dosage: 200 MG/M2, Indication: PANCREATIC NEUROENDOCRINE TUMOUR METASTATIC, Action: Unknown
|
['xeloda', 'afinitor', 'sutent', 'somatuline lp', 'temodal', 'xgeva']
|
['capecitabine', 'denosumab', 'temozolomide', 'lanreotide acetate', 'sunitinib malate', 'everolimus']
|
['pancreatic neuroendocrine tumour metastatic', 'product used for unknown indication', 'pancreatic carcinoma']
|
14,666,219
| 3
|
Germany
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
DE-TEVA-2018-DE-873367
|
Regulatory Authority
|
FDA-Public Use
| 51
|
Year
|
Female
|
Dizziness (Not Recovered / Not Resolved / Ongoing); Pneumonia (Not Recovered / Not Resolved / Ongoing); Visual impairment (Not Recovered / Not Resolved / Ongoing)
|
TAMOXIFEN (Suspect), Active: TAMOXIFEN, Dosage: 20 MILLIGRAM DAILY;, Indication: BREAST CANCER, Action: Drug Withdrawn, Additional: No
|
['tamoxifen']
|
['tamoxifen']
|
['breast cancer']
|
14,667,291
| 4
|
Korea (the Republic of)
|
Report from study
|
No
| null | 20,180,322
| 20,180,711
|
KR-ASTRAZENECA-2018SE34051
|
Regulatory Authority
|
FDA-Public Use
| 899
|
Month
|
Female
|
Lipase increased (Not Recovered / Not Resolved / Ongoing)
|
DURVALUMAB. (Suspect), Active: DURVALUMAB, Indication: NEOPLASM, Action: Dose not changed
|
['durvalumab.']
|
['durvalumab']
|
['neoplasm']
|
14,668,826
| 2
|
France
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
FR-AUROBINDO-AUR-APL-2018-015669
|
Regulatory Authority
|
FDA-Public Use
| 37
|
Year
|
Female
|
Dyskinesia (Fatal); Extrapyramidal disorder (Not Recovered / Not Resolved / Ongoing)
|
ABILIFY (Suspect), Active: ARIPIPRAZOLE, Dosage: 15 MILLIGRAM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No; ABILIFY (Suspect), Active: ARIPIPRAZOLE, Dosage: UNK, Indication: ABNORMAL BEHAVIOUR, Action: Drug Withdrawn, Additional: No; OLANZAPINE. (Suspect), Active: OLANZAPINE, Dosage: INCONNUE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['abilify', 'olanzapine.']
|
['aripiprazole', 'olanzapine']
|
['abnormal behaviour', 'product used for unknown indication']
|
14,668,830
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-APOTEX-2018AP008767
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Parkinsonism (Recovering / Resolving); Hypothyroidism (Recovering / Resolving)
|
LITHIUM CARBONATE. (Suspect), Active: LITHIUM CARBONATE, Dosage: UNK, Indication: BIPOLAR DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['lithium carbonate.']
|
['lithium carbonate']
|
['bipolar disorder']
|
14,670,358
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-TEVA-2018-US-872981
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Female
|
Colitis microscopic (Recovering / Resolving); Rectal ulcer (Recovering / Resolving); Gastritis (Recovering / Resolving)
|
VENLAFAXINE (Suspect), Active: VENLAFAXINE HYDROCHLORIDE, Indication: MAJOR DEPRESSION, Action: Drug Withdrawn, Additional: Yes
|
['venlafaxine']
|
['venlafaxine hydrochloride']
|
['major depression']
|
14,672,094
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-ACADIA PHARMACEUTICALS INC.-ACA-2018-008099
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Abnormal behaviour (Recovered / Resolved); Anger (Recovered / Resolved)
|
NUPLAZID (Suspect), Active: PIMAVANSERIN TARTRATE, Indication: HALLUCINATION, Action: Drug Withdrawn, Additional: Yes; NUPLAZID (Suspect), Active: PIMAVANSERIN TARTRATE, Dosage: 34 MG, QD, Indication: PARKINSON^S DISEASE PSYCHOSIS, Action: Drug Withdrawn, Additional: Yes; NUPLAZID (Suspect), Active: PIMAVANSERIN TARTRATE, Indication: DELUSION, Action: Drug Withdrawn, Additional: Yes
|
['nuplazid']
|
['pimavanserin tartrate']
|
['hallucination', 'parkinson^s disease psychosis', 'delusion']
|
14,672,771
| 6
|
Canada
|
Other
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
CA-APOTEX-2018AP008126
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Nasopharyngitis (Not Recovered / Not Resolved / Ongoing); Drug dose omission (Not Recovered / Not Resolved / Ongoing); Chills (Not Recovered / Not Resolved / Ongoing); Cushingoid (Not Recovered / Not Resolved / Ongoing); Cough (Not Recovered / Not Resolved / Ongoing); Asthma (Not Recovered / Not Resolved / Ongoing); Influenza (Not Recovered / Not Resolved / Ongoing); Concomitant disease aggravated (Not Recovered / Not Resolved / Ongoing); Drug ineffective (Not Recovered / Not Resolved / Ongoing); Apnoea (Not Recovered / Not Resolved / Ongoing); Oropharyngeal pain (Not Recovered / Not Resolved / Ongoing); Hypertension (Not Recovered / Not Resolved / Ongoing); Chronic obstructive pulmonary disease (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing); Productive cough (Not Recovered / Not Resolved / Ongoing); Dyspnoea (Not Recovered / Not Resolved / Ongoing); Eosinophilia (Not Recovered / Not Resolved / Ongoing); Breath sounds abnormal (Not Recovered / Not Resolved / Ongoing); Pyrexia (Not Recovered / Not Resolved / Ongoing)
|
BREO ELLIPTA (Suspect), Active: FLUTICASONE FUROATE\VILANTEROL TRIFENATATE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; MEPOLIZUMAB (Suspect), Active: MEPOLIZUMAB, Dosage: 100 MG, UNK, Indication: ASTHMA, Action: Unknown, Additional: Doesn't Apply; PREDNISONE. (Suspect), Active: PREDNISONE, Dosage: 15 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; SALBUTAMOL (Suspect), Active: ALBUTEROL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['breo ellipta', 'salbutamol', 'prednisone.', 'mepolizumab']
|
['albuterol', 'fluticasone furoate\\vilanterol trifenatate', 'prednisone', 'mepolizumab']
|
['asthma', 'product used for unknown indication']
|
14,673,257
| 2
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
BR-009507513-1803BRA007569
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Diabetes mellitus inadequate control (Recovered / Resolved)
|
JANUMET (Suspect), Active: METFORMIN HYDROCHLORIDE\SITAGLIPTIN PHOSPHATE, Dosage: 1 TABLET 50/1000MG, TWICE A DAY, Indication: DIABETES MELLITUS, Action: Drug Withdrawn, Additional: Yes
|
['janumet']
|
['metformin hydrochloride\\sitagliptin phosphate']
|
['diabetes mellitus']
|
14,673,299
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,323
| 20,180,711
|
US-ROCHE-2094025
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Death (Fatal)
|
ACTIVASE (Suspect), Active: ALTEPLASE, Indication: PULMONARY EMBOLISM, Action: Not applicable
|
['activase']
|
['alteplase']
|
['pulmonary embolism']
|
14,676,247
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
US-CELGENEUS-USA-20180307493
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Pneumonia (Recovered / Resolved)
|
POMALYST (Suspect), Active: POMALIDOMIDE, Dosage: 2 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; POMALYST (Suspect), Active: POMALIDOMIDE, Dosage: 2 MILLIGRAM, Action: Drug Withdrawn, Additional: Yes
|
['pomalyst']
|
['pomalidomide']
|
['plasma cell myeloma']
|
14,676,265
| 3
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
DE-ROCHE-1695697
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Urinary tract obstruction (Recovered / Resolved); Urinary tract infection (Recovered / Resolved); Acute kidney injury (Recovered / Resolved); Pneumonia (Recovered / Resolved)
|
CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: ON 10/MAR/2016, RECEIVED THE MOST RECENT CYCLE OF CHOP PRIOR TO SAE, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; LEUCOVORIN. (Suspect), Active: LEUCOVORIN, Dosage: 30 MG/250 ML, 4 TIMES IN DAY. ON 10/MAR/2016, RECEIVED THE MOST RECENT CYCLE OF CHOP PRIOR TO SAE., Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; PEGFILGRASTIM (Suspect), Active: PEGFILGRASTIM, Dosage: DAILY DOSE: 6 MG MILLIGRAM(S) EVERY 2 WEEK, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; VINCRISTINE (Suspect), Active: VINCRISTINE, Dosage: DAILY DOSE: 3.91 MG MILLIGRAM(S) EVERY 2 WEEK, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; DOXORUBICINE (Suspect), Active: DOXORUBICIN, Dosage: ON 10/MAR/2016, RECEIVED THE MOST RECENT CYCLE OF CHOP PRIOR TO SAE, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE DISODIUM (Suspect), Active: METHOTREXATE SODIUM, Dosage: 50% DOSE REDUCTION DUE TO GFR INITIAL 58ML/MIN, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Dosage: ON 10/MAR/2016, RECEIVED THE MOST RECENT CYCLE OF CHOP PRIOR TO SAE, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; RITUXIMAB. (Suspect), Active: RITUXIMAB, Dosage: ON 14 DAY, MOST RECENT CYCLE NO 3, THE DATE OF MOST RECENT DOSE OF RITUXIMAB 09/MAR/2016?MOST RECENT, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply
|
['cyclophosphamide.', 'doxorubicine', 'prednisolone.', 'vincristine', 'rituximab.', 'pegfilgrastim', 'leucovorin.', 'methotrexate disodium']
|
['vincristine', 'doxorubicin', 'leucovorin', 'methotrexate sodium', 'rituximab', 'cyclophosphamide', 'prednisolone', 'pegfilgrastim']
|
['b-cell lymphoma']
|
14,676,292
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
US-ABBVIE-18P-163-2297028-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Death (Fatal)
|
VENCLEXTA (Suspect), Active: VENETOCLAX, Indication: ACUTE MYELOID LEUKAEMIA, Action: Not applicable; VENCLEXTA (Suspect), Active: VENETOCLAX, Action: Not applicable
|
['venclexta']
|
['venetoclax']
|
['acute myeloid leukaemia']
|
14,666,244
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
US-PFIZER INC-2018119217
|
Regulatory Authority
|
FDA-Public Use
| 30
|
Year
|
Male
|
Liver abscess (Recovered / Resolved)
|
ATROPINE SULFATE/DIPHENOXYLATE HYDROCHLORIDE (Suspect), Active: ATROPINE SULFATE\DIPHENOXYLATE HYDROCHLORIDE, Dosage: UNK, Indication: DIARRHOEA, Action: Unknown, Additional: Doesn't Apply
|
['atropine sulfate/diphenoxylate hydrochloride']
|
['atropine sulfate\\diphenoxylate hydrochloride']
|
['diarrhoea']
|
14,670,392
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
US-TEVA-2018-US-873079
|
Regulatory Authority
|
FDA-Public Use
| 32
|
Year
|
Male
|
Drug reaction with eosinophilia and systemic symptoms (Recovered / Resolved)
|
AMOXICILLIN W/CLAVULANIC ACID (Suspect), Active: AMOXICILLIN\CLAVULANIC ACID, Dosage: AN ADDITIONAL COURSE OF AMOXICILLIN/CLAVULANIC ACID FOR THE INITIAL DIAGNOSIS OF INFLUENZA AND PN..., Indication: PNEUMONIA, Action: Unknown, Additional: Doesn't Apply; AMOXICILLIN W/CLAVULANIC ACID (Suspect), Active: AMOXICILLIN\CLAVULANIC ACID, Indication: INFLUENZA, Action: Unknown, Additional: Doesn't Apply; AMOXICILLIN W/CLAVULANIC ACID (Suspect), Active: AMOXICILLIN\CLAVULANIC ACID, Indication: PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['amoxicillin w/clavulanic acid']
|
['amoxicillin\\clavulanic acid']
|
['prophylaxis', 'influenza', 'pneumonia']
|
14,673,308
| 2
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
JP-TAIHO ONCOLOGY INC-JPTT180224
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Vomiting (Recovering / Resolving); Hypokalaemia (Recovering / Resolving)
|
AVASTIN (Suspect), Active: BEVACIZUMAB, Indication: COLORECTAL CANCER RECURRENT, Action: Drug Withdrawn, Additional: Yes; LONSURF (Suspect), Active: TIPIRACIL HYDROCHLORIDE\TRIFLURIDINE, Dosage: 100 MG/DAY, ON DAYS 1-5 AND 8-12 OF EACH 28-DAY CYCLE, CYCLE 1, Indication: COLORECTAL CANCER RECURRENT, Action: Drug Withdrawn, Additional: Yes
|
['lonsurf', 'avastin']
|
['tipiracil hydrochloride\\trifluridine', 'bevacizumab']
|
['colorectal cancer recurrent']
|
14,673,330
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-KERYX BIOPHARMACEUTICALS INC.-2018US003792
|
Regulatory Authority
|
FDA-Public Use
| 37
|
Year
|
Female
|
Seizure (Recovered / Resolved)
|
AURYXIA (Suspect), Active: TETRAFERRIC TRICITRATE DECAHYDRATE, Dosage: 1 G (1 TABLET), TID WITH MEALS, Indication: HYPERPHOSPHATAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['auryxia']
|
['tetraferric tricitrate decahydrate']
|
['hyperphosphataemia']
|
14,666,357
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
FR-ELI_LILLY_AND_COMPANY-FR201710002748
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Female
|
Pancreatic carcinoma (Not Recovered / Not Resolved / Ongoing)
|
TRULICITY (Suspect), Active: DULAGLUTIDE, Dosage: 1.5 MG, WEEKLY (1/W), Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn, Additional: No
|
['trulicity']
|
['dulaglutide']
|
['type 2 diabetes mellitus']
|
14,667,394
| 2
|
Canada
|
Other
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
CA-APOTEX-2018AP008008
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Female
|
Malaise (Fatal); Acute abdomen (Fatal); Drug screen positive (Fatal); Peptic ulcer perforation (Fatal)
|
DIPHENHYDRAMINE. (Suspect), Active: DIPHENHYDRAMINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['diphenhydramine.']
|
['diphenhydramine']
|
['product used for unknown indication']
|
14,668,100
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
US-MYLANLABS-2018M1016914
|
Regulatory Authority
|
FDA-Public Use
| 35
|
Year
|
Female
|
Post transplant distal limb syndrome (Recovering / Resolving)
|
TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: 2 MG AM, 1 MG PM ON POD: 93-121, Action: Dose not changed; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: 1 MG AM, 0.5 MG PM ON POD: 511-520, Action: Dose not changed; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: POD: 507-510, Action: Dose not changed; EVEROLIMUS. (Suspect), Active: EVEROLIMUS, Dosage: POD: 14-15; 34-81, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: POD:13-13; 69-73, Action: Dose not changed; EVEROLIMUS. (Suspect), Active: EVEROLIMUS, Dosage: POD: 16-33, Action: Unknown, Additional: Doesn't Apply; CELLCEPT (Suspect), Active: MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL HYDROCHLORIDE, Dosage: POD: 1-17; 81-116, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: POD: 4-5; 34-52; 343-355, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Dose not changed; MYFORTIC (Suspect), Active: MYCOPHENOLATE SODIUM, Dosage: 540 TWICE A DAY; POD: 361-520, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: POD: 6-8; 32-33; 53-66; 74-92; 122-336; 341-342;356-506, Action: Dose not changed; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: POD: 9-12; 14-31; 67-68; 337-340, Action: Dose not changed; MYFORTIC (Suspect), Active: MYCOPHENOLATE SODIUM, Dosage: 720 TWICE A DAY; POD: 116-340, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['everolimus.', 'tacrolimus.', 'cellcept', 'myfortic']
|
['tacrolimus', 'everolimus', 'mycophenolate sodium', 'mycophenolate mofetil\\mycophenolate mofetil hydrochloride']
|
['immunosuppressant drug therapy', 'product used for unknown indication']
|
14,669,694
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018047658
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Colectomy (Recovering / Resolving)
|
ANORO ELLIPTA (Suspect), Active: UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE, Dosage: 1 PUFF(S), 1D, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['anoro ellipta']
|
['umeclidinium bromide\\vilanterol trifenatate']
|
['chronic obstructive pulmonary disease']
|
14,669,750
| 4
|
Poland
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
PL-ABBVIE-18S-129-2296954-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Alcoholism (Recovering / Resolving); Depression (Recovering / Resolving)
|
VIEKIRAX (Suspect), Active: OMBITASVIR\PARITAPREVIR\RITONAVIR, Indication: HEPATITIS C, Action: Unknown, Additional: Doesn't Apply; EXVIERA (Suspect), Active: DASABUVIR, Indication: HEPATITIS C, Action: Unknown, Additional: Doesn't Apply
|
['exviera', 'viekirax']
|
['ombitasvir\\paritaprevir\\ritonavir', 'dasabuvir']
|
['hepatitis c']
|
14,669,767
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018GSK047955
|
Regulatory Authority
|
FDA-Public Use
| 75
|
Year
|
Female
|
Paraesthesia oral (Recovered / Resolved); Flushing (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Headache (Recovered / Resolved)
|
NUCALA (Suspect), Active: MEPOLIZUMAB, Dosage: UNK, Action: Drug Withdrawn, Additional: Yes; NUCALA (Suspect), Active: MEPOLIZUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
|
['nucala']
|
['mepolizumab']
|
['product used for unknown indication']
|
14,671,280
| 2
|
Germany
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
PHHY2018DE047378
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Bone pain (Not Recovered / Not Resolved / Ongoing)
|
ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 5 MG, Q12MO, Indication: OSTEOPOROSIS, Action: Not applicable; ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 1 DF, Q12MO, Action: Not applicable
|
['aclasta']
|
['zoledronic acid']
|
['osteoporosis']
|
14,671,293
| 2
|
Germany
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,322
| 20,180,711
|
DE-ROCHE-2092174
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Angioedema (Recovered / Resolved); Pruritus (Recovered / Resolved)
|
XOLAIR (Suspect), Active: OMALIZUMAB, Indication: CHRONIC SPONTANEOUS URTICARIA, Action: Dose not changed
|
['xolair']
|
['omalizumab']
|
['chronic spontaneous urticaria']
|
14,671,296
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-BEH-2018088883
|
Regulatory Authority
|
FDA-Public Use
| 50
|
Year
|
Male
|
Drug ineffective (Recovered / Resolved)
|
RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: UNK, Action: Not applicable; RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: 6 G, UNK, Action: Not applicable; RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: 7 G, UNK, Indication: FACTOR I DEFICIENCY, Action: Not applicable; RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: 2 G, UNK, Indication: HYPOFIBRINOGENAEMIA, Action: Not applicable; RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: 8 G, UNK, Action: Not applicable; RIASTAP (Suspect), Active: FIBRINOGEN HUMAN, Dosage: 4 G, UNK, Action: Not applicable
|
['riastap']
|
['fibrinogen human']
|
['hypofibrinogenaemia', 'factor i deficiency']
|
14,672,787
| 6
|
Canada
|
Other
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
CA-APOTEX-2018AP008160
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Male
|
Dyspnoea (Recovered / Resolved); Cough (Recovered / Resolved); Nasopharyngitis (Recovered / Resolved); Breath sounds abnormal (Recovered / Resolved); Fatigue (Recovered / Resolved); Discomfort (Recovered / Resolved); Pneumonia (Recovered / Resolved); Respiratory rate increased (Recovered / Resolved); Hypopnoea (Recovered / Resolved); Rhinorrhoea (Recovered / Resolved); Stridor (Recovered / Resolved); Drug ineffective (Recovered / Resolved); Pain (Recovered / Resolved); Pallor (Recovered / Resolved); Parkinson^s disease (Recovered / Resolved); Pyrexia (Recovered / Resolved); Wheezing (Recovered / Resolved); Feeling cold (Recovered / Resolved); Headache (Recovered / Resolved)
|
SALBUTAMOL (Suspect), Active: ALBUTEROL, Dosage: 2 DF, UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; MEPOLIZUMAB (Suspect), Active: MEPOLIZUMAB, Dosage: 100 MG, UNK, Indication: ASTHMA, Action: Unknown, Additional: Doesn't Apply; MEPOLIZUMAB (Suspect), Active: MEPOLIZUMAB, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['salbutamol', 'mepolizumab']
|
['albuterol', 'mepolizumab']
|
['asthma', 'product used for unknown indication']
|
14,674,358
| 2
|
Korea (the Republic of)
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
KR-GLAXOSMITHKLINE-KR2018GSK048597
|
Regulatory Authority
|
FDA-Public Use
| 50
|
Year
|
Female
|
Eosinophilic granulomatosis with polyangiitis (Not Recovered / Not Resolved / Ongoing)
|
FLUTICASONE FUROATE + VILANTEROL TRIFENATATE (Suspect), Active: FLUTICASONE FUROATE\VILANTEROL TRIFENATATE, Dosage: 1 PUFF(S), QD, Indication: ASTHMA, Action: Drug Withdrawn, Additional: No
|
['fluticasone furoate + vilanterol trifenatate']
|
['fluticasone furoate\\vilanterol trifenatate']
|
['asthma']
|
14,664,763
| 3
|
China
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
US-ASTRAZENECA-2018SE29192
|
Regulatory Authority
|
FDA-Public Use
| 25,144
|
Day
|
Male
|
Influenza (Recovered / Resolved)
|
GLYCOPYRRONIUM + FORMOTEROL FUMARATE INHALATION AEROSOL (PEARL) (Suspect), Active: GLYCOPYRRONIUM\FORMOTEROL FUMARATE, Dosage: 14.4/9.6 ???G EX-ACTUATOR BID, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['glycopyrronium + formoterol fumarate inhalation aerosol (pearl)']
|
['glycopyrronium\\formoterol fumarate']
|
['chronic obstructive pulmonary disease']
|
14,670,471
| 2
|
Sweden
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
SE-TEVA-2018-SE-868074
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Rash pruritic (Recovered / Resolved); Furuncle (Recovered / Resolved); Feeling abnormal (Recovered / Resolved)
|
LOSARTAN TEVA (Suspect), Active: LOSARTAN, Dosage: 100 MILLIGRAM DAILY;, Action: Drug Withdrawn, Additional: Yes
|
['losartan teva']
|
['losartan']
|
[]
|
14,672,288
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,323
| 20,180,711
|
US-AMGEN-USASL2018039101
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Asthma (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Action: Drug Withdrawn, Additional: No; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: No
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
14,665,674
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
US-EXELIXIS-XL18418013002
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Female
|
Small intestinal obstruction (Recovered / Resolved)
|
PANITUMUMAB (Suspect), Active: PANITUMUMAB, Dosage: 3 MG/KG, Q 14 DAYS, Indication: COLORECTAL CANCER, Action: Not applicable; XL184 (Suspect), Active: CABOZANTINIB, Dosage: 20 MG, QD, Indication: COLORECTAL CANCER, Action: Drug Withdrawn, Additional: Yes
|
['xl184', 'panitumumab']
|
['panitumumab', 'cabozantinib']
|
['colorectal cancer']
|
14,669,831
| 3
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,322
| 20,180,711
|
US-BAYER-2018-051285
|
Regulatory Authority
|
FDA-Public Use
| 49
|
Year
|
Female
|
Pain (Not Recovered / Not Resolved / Ongoing)
|
ADEMPAS (Suspect), Active: RIOCIGUAT, Dosage: 2.5 MG, TID, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Unknown; ADEMPAS (Suspect), Active: RIOCIGUAT, Dosage: UNK, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Unknown
|
['adempas']
|
['riociguat']
|
['pulmonary arterial hypertension']
|
14,669,854
| 3
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,322
| 20,180,711
|
GB-DSJP-DSE-2018-111090
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Pneumonia (Fatal)
|
LIXIANA (Suspect), Active: EDOXABAN TOSYLATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['lixiana']
|
['edoxaban tosylate']
|
['product used for unknown indication']
|
14,671,471
| 2
|
Australia
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
AU-ROCHE-2087836
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Febrile neutropenia (Not Recovered / Not Resolved / Ongoing)
|
PACLITAXEL. (Suspect), Active: PACLITAXEL, Dosage: ON 19/FEB/2018, HE RECEIVED THE LAST DOSE PRIOR TO EVENT, Indication: OVARIAN CANCER, Action: Dose not changed; ATEZOLIZUMAB. (Suspect), Active: ATEZOLIZUMAB, Dosage: LAST DOSE PRIOR TO EVENT ON 19 FEB 2018, Indication: OVARIAN CANCER, Action: Dose not changed; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Dosage: ON 19/FEB/2018, HE RECEIVED THE LAST DOSE PRIOR TO EVENT, Indication: OVARIAN CANCER, Action: Dose not changed
|
['carboplatin.', 'atezolizumab.', 'paclitaxel.']
|
['carboplatin', 'atezolizumab', 'paclitaxel']
|
['ovarian cancer']
|
14,671,517
| 2
|
Brazil
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
BR-ROCHE-2089249
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Disease progression (Not Recovered / Not Resolved / Ongoing)
|
HERCEPTIN (Suspect), Active: TRASTUZUMAB, Action: Drug Withdrawn, Additional: No; PERJETA (Suspect), Active: PERTUZUMAB, Dosage: INITIAL DOSE, Indication: HER-2 POSITIVE BREAST CANCER, Action: Drug Withdrawn, Additional: No; PERJETA (Suspect), Active: PERTUZUMAB, Dosage: MAINTAINENCE DOSE, Action: Drug Withdrawn, Additional: No; HERCEPTIN (Suspect), Active: TRASTUZUMAB, Dosage: 12 CYCLES, Indication: HER-2 POSITIVE BREAST CANCER, Action: Drug Withdrawn, Additional: No
|
['herceptin', 'perjeta']
|
['trastuzumab', 'pertuzumab']
|
['her-2 positive breast cancer']
|
14,675,674
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,323
| 20,180,711
|
US-CELGENEUS-USA-20180307632
|
Regulatory Authority
|
FDA-Public Use
| 75
|
Year
|
Male
|
Toothache (Recovered / Resolved)
|
ZOMETA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 3-4 MG OF L/WEEKS, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 10 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Dose not changed; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 10 MILLIGRAM, Action: Dose not changed
|
['revlimid', 'zometa']
|
['zoledronic acid', 'lenalidomide']
|
['plasma cell myeloma']
|
14,675,681
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
US-JAZZ-2018-US-004837
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Pneumonia (Recovering / Resolving); Fall (Recovered / Resolved); Anaphylactic shock (Recovered / Resolved); Drug hypersensitivity (Not Recovered / Not Resolved / Ongoing); Vomiting projectile (Recovered / Resolved); Suicidal ideation (Recovered / Resolved)
|
XYREM (Suspect), Active: SODIUM OXYBATE, Dosage: 2.25 G, BID, Indication: CATAPLEXY, Action: Unknown, Additional: Doesn't Apply; XYREM (Suspect), Active: SODIUM OXYBATE, Dosage: 2.25 G, BID, Indication: NARCOLEPSY, Action: Unknown, Additional: Doesn't Apply; ALEVE (Suspect), Active: NAPROXEN SODIUM, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; TYLENOL WITH CODEINE (Suspect), Active: ACETAMINOPHEN\CODEINE PHOSPHATE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; IBUPROFEN. (Suspect), Active: IBUPROFEN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['tylenol with codeine', 'xyrem', 'ibuprofen.', 'aleve']
|
['sodium oxybate', 'acetaminophen\\codeine phosphate', 'ibuprofen', 'naproxen sodium']
|
['narcolepsy', 'product used for unknown indication', 'cataplexy']
|
14,676,541
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,324
| 20,180,711
|
US-APOTEX-2018AP008358
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Male
|
Mucormycosis (Fatal); Transplant rejection (Fatal)
|
METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Indication: IMMUNOSUPPRESSION, Action: Not applicable; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Indication: IMMUNOSUPPRESSION, Action: Not applicable; PREDNISONE. (Suspect), Active: PREDNISONE, Indication: IMMUNOSUPPRESSION, Action: Not applicable; TACROLIMUS. (Suspect), Active: TACROLIMUS, Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Not applicable; TACROLIMUS. (Suspect), Active: TACROLIMUS, Indication: IMMUNOSUPPRESSION, Action: Not applicable; METHYLPREDNISOLONE. (Suspect), Active: METHYLPREDNISOLONE, Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Not applicable; SULFAMETHOXAZOLE AND TRIMETHOPRIM (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Not applicable; SULFAMETHOXAZOLE AND TRIMETHOPRIM (Suspect), Active: SULFAMETHOXAZOLE\TRIMETHOPRIM, Indication: IMMUNOSUPPRESSION, Action: Not applicable
|
['methylprednisolone.', 'sulfamethoxazole and trimethoprim', 'prednisone.', 'tacrolimus.', 'mycophenolate']
|
['sulfamethoxazole\\trimethoprim', 'methylprednisolone', 'mycophenolic acid', 'tacrolimus', 'prednisone']
|
['prophylaxis against transplant rejection', 'immunosuppression']
|
14,684,442
| 2
|
Canada
|
Other
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
CA-APOTEX-2018AP008514
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Male
|
Rash (Not Recovered / Not Resolved / Ongoing)
|
REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 10 MG, 21 EVERY 28 DAYS, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Dosage: 20 MG, 3 EVERY 21 DAYS, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; PANTOPRAZOLE (Suspect), Active: PANTOPRAZOLE, Dosage: 40 MG, QD, Indication: PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['dexamethasone.', 'pantoprazole', 'revlimid']
|
['lenalidomide', 'pantoprazole', 'dexamethasone']
|
['prophylaxis', 'plasma cell myeloma']
|
14,685,558
| 2
|
Argentina
|
Report from study
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes)
| 20,180,327
| 20,180,711
|
PHHY2018AR052588
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Myocardial infarction (Recovering / Resolving); Renal disorder (Recovered / Resolved); Hypoaesthesia (Recovering / Resolving); Cardiac failure (Recovering / Resolving); Malaise (Recovering / Resolving); Apparent death (Recovered / Resolved); Skin discolouration (Recovered / Resolved); Nervousness (Not Recovered / Not Resolved / Ongoing); Haematuria (Recovered / Resolved); Dehydration (Recovered / Resolved); Syncope (Recovered / Resolved); Sciatica (Recovering / Resolving); Stress (Not Recovered / Not Resolved / Ongoing)
|
ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 50 MG, BID, Indication: CARDIAC FAILURE, Action: Unknown, Additional: Doesn't Apply
|
['entresto']
|
['sacubitril\\valsartan']
|
['cardiac failure']
|
14,682,543
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
US-AUROBINDO-AUR-APL-2018-016658
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Female
|
Anaphylactic reaction (Recovered / Resolved); Cardiac arrest (Recovered / Resolved)
|
VANCOMYCIN (Suspect), Active: VANCOMYCIN, Dosage: 1 GRAM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; LIDOCAINE. (Suspect), Active: LIDOCAINE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['lidocaine.', 'vancomycin']
|
['lidocaine', 'vancomycin']
|
['product used for unknown indication']
|
14,682,591
| 2
|
United States of America
|
Report from study
|
Yes
|
Disabling (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
US-AMGEN-USASL2018038952
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Female
|
Cystitis (Not Recovered / Not Resolved / Ongoing); Pulmonary embolism (Recovered / Resolved); Pneumonia (Recovered / Resolved); Urosepsis (Recovering / Resolving)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: 60 MG, Q6MO, Indication: OSTEOPOROSIS, Action: Dose not changed; PROLIA (Suspect), Active: DENOSUMAB, Dosage: 60 MG, Q6MO, Indication: OSTEOPOROSIS POSTMENOPAUSAL, Action: Dose not changed
|
['prolia']
|
['denosumab']
|
['osteoporosis postmenopausal', 'osteoporosis']
|
14,685,622
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
US-UNITED THERAPEUTICS-UNT-2018-002837
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Male
|
Oedema (Not Recovered / Not Resolved / Ongoing); Dyspnoea (Not Recovered / Not Resolved / Ongoing); Blood creatinine increased (Not Recovered / Not Resolved / Ongoing); Burning sensation (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing); Nausea (Not Recovered / Not Resolved / Ongoing); Injection site pruritus (Not Recovered / Not Resolved / Ongoing); Pain in extremity (Not Recovered / Not Resolved / Ongoing); Dyspnoea exertional (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing); Abdominal distension (Not Recovered / Not Resolved / Ongoing)
|
REMODULIN (Suspect), Active: TREPROSTINIL, Dosage: 0.019 ?G/KG, CONTINUING, Action: Drug Withdrawn, Additional: No; CHLORHEXIDINE (Suspect), Active: CHLORHEXIDINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; REMODULIN (Suspect), Active: TREPROSTINIL, Dosage: 0.004 ?G/KG, CONTINUING, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Drug Withdrawn, Additional: No; REMODULIN (Suspect), Active: TREPROSTINIL, Dosage: 0.018 ?G/KG, CONTINUING, Action: Drug Withdrawn, Additional: No
|
['remodulin', 'chlorhexidine']
|
['treprostinil', 'chlorhexidine']
|
['pulmonary arterial hypertension', 'product used for unknown indication']
|
14,686,373
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,180,327
| 20,180,711
|
US-ALKERMES INC.-ALK-2018-000793
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Underdose (Not Recovered / Not Resolved / Ongoing); Syringe issue (Not Recovered / Not Resolved / Ongoing)
|
ARISTADA (Suspect), Active: ARIPIPRAZOLE LAUROXIL, Dosage: 882 MG, QMO, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['aristada']
|
['aripiprazole lauroxil']
|
['product used for unknown indication']
|
14,687,114
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,328
| 20,180,711
|
US-BIOGEN-2018BI00547667
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Cardiac disorder (Recovered / Resolved); Hypertension (Recovered / Resolved); Intervertebral disc disorder (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Pyrexia (Recovered / Resolved); Urinary tract infection (Recovered / Resolved)
|
TYSABRI (Suspect), Active: NATALIZUMAB, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['tysabri']
|
['natalizumab']
|
['multiple sclerosis']
|
14,687,128
| 2
|
Czechia
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,328
| 20,180,711
|
CZ-BIOGEN-2017BI00469842
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Female
|
Maternal exposure during pregnancy (Recovered / Resolved)
|
TYSABRI (Suspect), Active: NATALIZUMAB, Action: Unknown, Additional: Doesn't Apply; TYSABRI (Suspect), Active: NATALIZUMAB, Indication: MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['tysabri']
|
['natalizumab']
|
['multiple sclerosis']
|
14,687,861
| 4
|
Turkey
|
Report from study
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes)
| 20,180,328
| 20,180,711
|
TR-ROCHE-2096931
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Male
|
Atelectasis (Recovering / Resolving); Lower respiratory tract infection (Recovering / Resolving)
|
ATEZOLIZUMAB. (Suspect), Active: ATEZOLIZUMAB, Dosage: DATE OF MOST RECENT DOSE PRIOR TO EVENT ONSET ON 23/FEB/2018 AT 12:25, Indication: NON-SMALL CELL LUNG CANCER STAGE IV, Action: Drug Withdrawn, Additional: Yes
|
['atezolizumab.']
|
['atezolizumab']
|
['non-small cell lung cancer stage iv']
|
14,677,487
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,325
| 20,180,711
|
US-JNJFOC-20180310392
|
Regulatory Authority
|
FDA-Public Use
| 41
|
Year
|
Female
|
Fatigue (Recovered / Resolved); Headache (Recovering / Resolving)
|
TREMFYA (Suspect), Active: GUSELKUMAB, Indication: PSORIASIS, Action: Unknown, Additional: Doesn't Apply
|
['tremfya']
|
['guselkumab']
|
['psoriasis']
|
14,677,507
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,325
| 20,180,711
|
US-MYLANLABS-2018M1013904
|
Regulatory Authority
|
FDA-Public Use
| 40
|
Year
|
Female
|
Product quality issue (Not Recovered / Not Resolved / Ongoing); Product adhesion issue (Not Recovered / Not Resolved / Ongoing)
|
LIDOCAINE PATCH (Suspect), Active: LIDOCAINE, Dosage: UNK, Indication: PAIN, Action: Drug Withdrawn, Additional: No
|
['lidocaine patch']
|
['lidocaine']
|
['pain']
|
14,679,086
| 2
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
PHHY2018BR049564
|
Regulatory Authority
|
FDA-Public Use
| 82
|
Year
|
Male
|
Type 2 diabetes mellitus (Not Recovered / Not Resolved / Ongoing); Speech disorder (Not Recovered / Not Resolved / Ongoing); Dysphonia (Not Recovered / Not Resolved / Ongoing)
|
FORASEQ (Suspect), Active: BUDESONIDE\FORMOTEROL FUMARATE, Dosage: 1 DF, QD, Indication: RESPIRATORY DISORDER, Action: Dose not changed; FORASEQ (Suspect), Active: BUDESONIDE\FORMOTEROL FUMARATE, Dosage: 2 CAPSULES IN MORNING AND 02 AT NIGHT, Action: Dose not changed
|
['foraseq']
|
['budesonide\\formoterol fumarate']
|
['respiratory disorder']
|
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