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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
14,658,051
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
JP-ROCHE-2088703
|
Regulatory Authority
|
FDA-Public Use
| 41
|
Year
|
Male
|
Altered state of consciousness (Recovering / Resolving); Seizure (Recovering / Resolving)
|
VALIXA (Suspect), Active: VALGANCICLOVIR, Indication: CYTOMEGALOVIRUS INFECTION, Action: Not applicable
|
['valixa']
|
['valganciclovir']
|
['cytomegalovirus infection']
|
14,658,069
| 3
|
Israel
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
IL-ABBVIE-18K-082-2290398-00
|
Regulatory Authority
|
FDA-Public Use
| 82
|
Year
|
Female
|
Psoriasis (Not Recovered / Not Resolved / Ongoing); C-reactive protein increased (Not Recovered / Not Resolved / Ongoing); Purpura (Not Recovered / Not Resolved / Ongoing); Faecal calprotectin increased (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: ARTHROPATHY, Action: Drug Withdrawn, Additional: No; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: No
|
['humira']
|
['adalimumab']
|
['crohn^s disease', 'arthropathy']
|
14,658,716
| 2
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-021158
|
Regulatory Authority
|
FDA-Public Use
| 89
|
Year
|
Female
|
Haemorrhage subcutaneous (Not Recovered / Not Resolved / Ongoing); Fibrin D dimer increased (Not Recovered / Not Resolved / Ongoing)
|
ELIQUIS (Suspect), Active: APIXABAN, Dosage: 2.5 MG, BID, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['eliquis']
|
['apixaban']
|
['cerebrovascular accident prophylaxis']
|
14,659,314
| 2
|
Canada
|
Other
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
CA-APOTEX-2018AP007873
|
Regulatory Authority
|
FDA-Public Use
| 42
|
Year
|
Female
|
Anaphylactic reaction (Recovered / Resolved)
|
APO-CLONAZEPAM - TAB 0.5MG (Suspect), Active: CLONAZEPAM, Dosage: 0.5 MG, TID, Indication: ANXIETY, Action: Unknown, Additional: Doesn't Apply
|
['apo-clonazepam - tab 0.5mg']
|
['clonazepam']
|
['anxiety']
|
14,662,986
| 3
|
Chile
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
CL-UCBSA-2018011426
|
Regulatory Authority
|
FDA-Public Use
| 4
|
Year
|
Female
|
Balance disorder (Recovered / Resolved); Disturbance in attention (Recovered / Resolved); Petit mal epilepsy (Recovering / Resolving); Muscle spasms (Recovered / Resolved); Generalised tonic-clonic seizure (Recovered / Resolved); Somnolence (Recovered / Resolved)
|
LACOSAMIDE. (Suspect), Active: LACOSAMIDE, Dosage: 37.5 MG AND 75 MG, 2X/DAY (BID), Action: Drug Withdrawn, Additional: Yes; LACOSAMIDE. (Suspect), Active: LACOSAMIDE, Dosage: 37.5 MG, ONCE DAILY (QD), Indication: EPILEPSY, Action: Drug Withdrawn, Additional: Yes; LACOSAMIDE. (Suspect), Active: LACOSAMIDE, Dosage: 75 MG, 2X/DAY (BID), Action: Drug Withdrawn, Additional: Yes
|
['lacosamide.']
|
['lacosamide']
|
['epilepsy']
|
14,654,121
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,319
| 20,180,711
|
US-BAYER-2018-049621
|
Regulatory Authority
|
FDA-Public Use
| 26
|
Year
|
Female
|
Abdominal pain upper (Recovered / Resolved)
|
MIRENA (Suspect), Active: LEVONORGESTREL, Dosage: 20 MCG/24HR, CONT, Indication: CONTRACEPTION, Action: Dose not changed
|
['mirena']
|
['levonorgestrel']
|
['contraception']
|
14,656,353
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
US-PFIZER INC-2018107765
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Female
|
Neuroendocrine carcinoma (Recovered / Resolved)
|
TIKOSYN (Suspect), Active: DOFETILIDE, Dosage: 250 MG, 2X/DAY, Indication: ATRIAL FIBRILLATION, Action: Dose not changed
|
['tikosyn']
|
['dofetilide']
|
['atrial fibrillation']
|
14,656,361
| 2
|
France
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
FR-PFIZER INC-2018106233
|
Regulatory Authority
|
FDA-Public Use
| 8
|
Year
|
Male
|
Pancreatitis (Recovered / Resolved with Sequelae)
|
METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: 12 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DOXORUBICIN HCL (Suspect), Active: DOXORUBICIN HYDROCHLORIDE, Dosage: 24 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; VINCRISTINE SULFATE. (Suspect), Active: VINCRISTINE SULFATE, Dosage: 1.5 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; PEGASPARGASE (Suspect), Active: PEGASPARGASE, Dosage: 2550 IU, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; CYTARABINE. (Suspect), Active: CYTARABINE, Dosage: 30 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Dosage: 10 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; HYDROCORTISONE. (Suspect), Active: HYDROCORTISONE, Dosage: 15 MG, 1X/DAY, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['vincristine sulfate.', 'doxorubicin hcl', 'methotrexate.', 'pegaspargase', 'dexamethasone.', 'cytarabine.', 'hydrocortisone.']
|
['hydrocortisone', 'pegaspargase', 'vincristine sulfate', 'doxorubicin hydrochloride', 'methotrexate', 'dexamethasone', 'cytarabine']
|
['acute lymphocytic leukaemia']
|
14,659,401
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
JP-OTSUKA-2018_006882
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Eosinophil count increased (Recovering / Resolving)
|
SAMSCA (Suspect), Active: TOLVAPTAN, Indication: FLUID RETENTION, Action: Dose not changed; SAMSCA (Suspect), Active: TOLVAPTAN, Dosage: 15 UNIT UNK, DAILY, Indication: CARDIAC FAILURE, Action: Dose not changed
|
['samsca']
|
['tolvaptan']
|
['cardiac failure', 'fluid retention']
|
14,660,070
| 3
|
France
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
FR-PFIZER INC-2018106964
|
Regulatory Authority
|
FDA-Public Use
| 6
|
Year
|
Male
|
Cholestasis (Recovered / Resolved)
|
VINCRISTINE SULFATE. (Suspect), Active: VINCRISTINE SULFATE, Dosage: 1.3 MG, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; 6-MERCAPTOPURINE MONOHYDRATE (Suspect), Active: MERCAPTOPURINE, Dosage: 44 MG, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Dosage: 12 MG, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Dosage: 22 MG, ONE DOSE, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Dosage: 5.5 MG, UNK, Action: Unknown, Additional: Doesn't Apply; ONCASPAR (Suspect), Active: PEGASPARGASE, Dosage: 2215.5 IU, UNK, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Dosage: 5.5 MG, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['vincristine sulfate.', 'oncaspar', 'dexamethasone.', 'methotrexate sodium.', '6-mercaptopurine monohydrate']
|
['pegaspargase', 'methotrexate sodium', 'vincristine sulfate', 'mercaptopurine', 'dexamethasone']
|
['acute lymphocytic leukaemia']
|
14,663,847
| 2
|
Canada
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
CA-APOTEX-2018AP007006
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Weight decreased (Recovered / Resolved)
|
ATOMOXETINE. (Suspect), Active: ATOMOXETINE HYDROCHLORIDE, Dosage: 0.38-0.68 MG/KG, UNK, Indication: ATTENTION DEFICIT/HYPERACTIVITY DISORDER, Action: Drug Withdrawn, Additional: Yes; GUANFACINE. (Suspect), Active: GUANFACINE, Dosage: 1 MG, UNK, Indication: ATTENTION DEFICIT/HYPERACTIVITY DISORDER, Action: Not applicable; LISDEXAMFETAMINE (Suspect), Active: LISDEXAMFETAMINE, Dosage: 20-40 MG, UNK, Indication: ATTENTION DEFICIT/HYPERACTIVITY DISORDER, Action: Drug Withdrawn, Additional: Yes; METHYLPHENIDATE. (Suspect), Active: METHYLPHENIDATE, Dosage: 20-40 MG, UNK, Action: Drug Withdrawn, Additional: Yes; METHYLPHENIDATE. (Suspect), Active: METHYLPHENIDATE, Dosage: 10-50 MG, UNK, Indication: ATTENTION DEFICIT/HYPERACTIVITY DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['atomoxetine.', 'lisdexamfetamine', 'guanfacine.', 'methylphenidate.']
|
['lisdexamfetamine', 'methylphenidate', 'guanfacine', 'atomoxetine hydrochloride']
|
['attention deficit/hyperactivity disorder']
|
14,654,829
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-024214
|
Regulatory Authority
|
FDA-Public Use
| 8
|
Decade
|
Male
|
Cardiac failure (Recovered / Resolved)
|
OPDIVO (Suspect), Active: NIVOLUMAB, Dosage: UNK, Indication: GASTRIC CANCER RECURRENT, Action: Unknown, Additional: Doesn't Apply
|
['opdivo']
|
['nivolumab']
|
['gastric cancer recurrent']
|
14,654,842
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,319
| 20,180,711
|
US-APOTEX-2018AP008565
|
Regulatory Authority
|
FDA-Public Use
| 39
|
Year
|
Female
|
Colitis (Recovering / Resolving)
|
MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: 1000 MG, BID, Indication: IMMUNOSUPPRESSION, Action: Dose reduced, Additional: Yes; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: 500 MG, BID, Action: Dose reduced, Additional: Yes
|
['mycophenolate']
|
['mycophenolic acid']
|
['immunosuppression']
|
14,655,613
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-TEVA-2018-US-872466
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Laceration (Recovered / Resolved); Vertigo (Recovered / Resolved); Concussion (Recovered / Resolved); Rib fracture (Not Recovered / Not Resolved / Ongoing)
|
METHOTREXATE. (Suspect), Active: METHOTREXATE, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['methotrexate.']
|
['methotrexate']
|
['rheumatoid arthritis']
|
14,657,411
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
US-APOTEX-2018AP008574
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Autoimmune hepatitis (Recovering / Resolving); Acute hepatic failure (Recovering / Resolving)
|
ATORVASTATIN (Suspect), Active: ATORVASTATIN, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; SIMVASTATIN. (Suspect), Active: SIMVASTATIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
|
['simvastatin.', 'atorvastatin']
|
['simvastatin', 'atorvastatin']
|
['product used for unknown indication']
|
14,658,198
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-JNJFOC-20180311816
|
Regulatory Authority
|
FDA-Public Use
| 6
|
Year
|
Female
|
Influenza (Recovered / Resolved)
|
CONCERTA (Suspect), Active: METHYLPHENIDATE HYDROCHLORIDE, Indication: ATTENTION DEFICIT/HYPERACTIVITY DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['concerta']
|
['methylphenidate hydrochloride']
|
['attention deficit/hyperactivity disorder']
|
14,658,205
| 2
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
BR-ROCHE-2087659
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Female
|
Back pain (Recovered / Resolved); Breast pain (Recovered / Resolved)
|
PERJETA (Suspect), Active: PERTUZUMAB, Indication: BREAST CANCER, Action: Drug Withdrawn, Additional: Yes
|
['perjeta']
|
['pertuzumab']
|
['breast cancer']
|
14,658,786
| 4
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-024160
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Male
|
Laryngospasm (Recovered / Resolved)
|
IPILIMUMAB (Suspect), Active: IPILIMUMAB, Dosage: 76.5 MG, UNK, Indication: HEAD AND NECK CANCER, Action: Drug Withdrawn, Additional: Yes; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 230 MG, Indication: HEAD AND NECK CANCER, Action: Drug Withdrawn, Additional: Yes
|
['nivolumab', 'ipilimumab']
|
['nivolumab', 'ipilimumab']
|
['head and neck cancer']
|
14,661,567
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
US-MYLANLABS-2018M1018847
|
Regulatory Authority
|
FDA-Public Use
| 51
|
Year
|
Female
|
White blood cell count increased (Recovered / Resolved); Neutrophil count increased (Recovered / Resolved)
|
CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; CLOZAPINE. (Suspect), Active: CLOZAPINE, Dosage: UNK, Action: Drug Withdrawn, Additional: Yes
|
['clozapine.']
|
['clozapine']
|
['product used for unknown indication']
|
14,663,184
| 2
|
Romania
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
RO-MYLANLABS-2018M1017418
|
Regulatory Authority
|
FDA-Public Use
| 3
|
Day
|
Male
|
Dysbacteriosis (Recovering / Resolving); Pathogen resistance (Recovering / Resolving); Bacterial disease carrier (Recovering / Resolving)
|
AMPICILLIN (Suspect), Active: AMPICILLIN, Dosage: 100 MG/KG, BID, Indication: PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply; GENTAMICIN. (Suspect), Active: GENTAMICIN, Dosage: 4 MG/KG, QD, Indication: PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['gentamicin.', 'ampicillin']
|
['gentamicin', 'ampicillin']
|
['prophylaxis']
|
14,663,185
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,321
| 20,180,711
|
JP-AMGEN-JPNSP2018038306
|
Regulatory Authority
|
FDA-Public Use
| 7
|
Decade
|
Female
|
Febrile neutropenia (Recovered / Resolved)
|
G-LASTA (Suspect), Active: PEGFILGRASTIM, Dosage: 3.6 MG, UNK, Indication: COLONY STIMULATING FACTOR PROPHYLAXIS, Action: Unknown, Additional: Doesn't Apply
|
['g-lasta']
|
['pegfilgrastim']
|
['colony stimulating factor prophylaxis']
|
14,653,354
| 5
|
Sweden
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
SE-STRIDES ARCOLAB LIMITED-2018SP001980
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Device related infection (Recovered / Resolved); Rash (Recovered / Resolved); Acute kidney injury (Recovered / Resolved); Pneumonia (Recovered / Resolved)
|
PACLITAXEL. (Suspect), Active: PACLITAXEL, Dosage: 340 MG, DAILY, Indication: NON-SMALL CELL LUNG CANCER, Action: Unknown; ENALAPRIL (Suspect), Active: ENALAPRIL, Dosage: UNK, Indication: HYPERTENSION, Action: Unknown; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Dosage: 703 MG, DAILY, Indication: NON-SMALL CELL LUNG CANCER, Action: Unknown; VANCOMYCIN (Suspect), Active: VANCOMYCIN, Dosage: UNK, Indication: PNEUMONIA, Action: Unknown; OXACILLIN (Suspect), Active: OXACILLIN SODIUM, Dosage: UNK, Indication: INFECTION, Action: Unknown; CIPROFLOXACIN. (Suspect), Active: CIPROFLOXACIN, Dosage: UNK, Indication: PNEUMONIA, Action: Unknown
|
['enalapril', 'carboplatin.', 'vancomycin', 'paclitaxel.', 'oxacillin', 'ciprofloxacin.']
|
['carboplatin', 'oxacillin sodium', 'enalapril', 'vancomycin', 'ciprofloxacin', 'paclitaxel']
|
['hypertension', 'infection', 'pneumonia', 'non-small cell lung cancer']
|
14,655,650
| 2
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes)
| 20,180,319
| 20,180,711
|
DE-CELGENEUS-DEU-20180301127
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Hypoglycaemia (Recovered / Resolved)
|
ADRIAMYCIN (Suspect), Active: DOXORUBICIN HYDROCHLORIDE, Indication: HAEMATOPOIETIC STEM CELL MOBILISATION, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: HAEMATOPOIETIC STEM CELL MOBILISATION, Action: Unknown, Additional: Doesn't Apply; MELPHALAN. (Suspect), Active: MELPHALAN, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; BORTEZOMIB (Suspect), Active: BORTEZOMIB, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Indication: HAEMATOPOIETIC STEM CELL MOBILISATION, Action: Unknown, Additional: Doesn't Apply; REVLIMID (Suspect), Active: LENALIDOMIDE, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes
|
['cyclophosphamide.', 'revlimid', 'bortezomib', 'melphalan.', 'dexamethasone.', 'adriamycin']
|
['lenalidomide', 'bortezomib', 'melphalan', 'cyclophosphamide', 'doxorubicin hydrochloride', 'dexamethasone']
|
['haematopoietic stem cell mobilisation', 'plasma cell myeloma']
|
14,657,481
| 3
|
Germany
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
DE-WEST-WARD PHARMACEUTICALS CORP.-DE-H14001-18-01887
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Circulatory collapse (Recovered / Resolved)
|
DOXORUBICINE (Suspect), Active: DOXORUBICIN, Indication: B-CELL LYMPHOMA, Action: Unknown; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Indication: B-CELL LYMPHOMA, Action: Unknown; LEUCOVORIN. (Suspect), Active: LEUCOVORIN, Indication: B-CELL LYMPHOMA, Action: Unknown; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Indication: B-CELL LYMPHOMA, Action: Unknown; PEGFILGRASTIM (Suspect), Active: PEGFILGRASTIM, Indication: B-CELL LYMPHOMA, Action: Unknown, Additional: Doesn't Apply; VINCRISTINE (Suspect), Active: VINCRISTINE, Indication: B-CELL LYMPHOMA, Action: Unknown; METHOTREXAT (Suspect), Active: METHOTREXATE, Indication: B-CELL LYMPHOMA, Action: Unknown; RITUXIMAB. (Suspect), Active: RITUXIMAB, Indication: B-CELL LYMPHOMA, Action: Unknown
|
['doxorubicine', 'cyclophosphamide.', 'prednisolone.', 'vincristine', 'methotrexat', 'rituximab.', 'pegfilgrastim', 'leucovorin.']
|
['vincristine', 'doxorubicin', 'leucovorin', 'rituximab', 'cyclophosphamide', 'methotrexate', 'prednisolone', 'pegfilgrastim']
|
['b-cell lymphoma']
|
14,661,005
| 4
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
DE-CELGENEUS-DEU-20180304177
|
Regulatory Authority
|
FDA-Public Use
| 69
|
Year
|
Male
|
Cholangitis (Recovered / Resolved); Cholangitis (Recovered / Resolved)
|
ABRAXANE (Suspect), Active: PACLITAXEL, Indication: PANCREATIC CARCINOMA, Action: Dose not changed; GEMCITABINE (Suspect), Active: GEMCITABINE\GEMCITABINE HYDROCHLORIDE, Indication: PANCREATIC CARCINOMA, Action: Dose not changed
|
['gemcitabine', 'abraxane']
|
['gemcitabine\\gemcitabine hydrochloride', 'paclitaxel']
|
['pancreatic carcinoma']
|
14,662,422
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
US-GILEAD-2018-0325647
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Hepatic cirrhosis (Not Recovered / Not Resolved / Ongoing); Confusional state (Recovered / Resolved)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 5 MG, QD, Indication: PORTOPULMONARY HYPERTENSION, Action: Dose not changed
|
['ambrisentan']
|
['ambrisentan']
|
['portopulmonary hypertension']
|
14,654,300
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
US-BIOGEN-2018BI00542555
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Seizure (Not Recovered / Not Resolved / Ongoing)
|
TYSABRI (Suspect), Active: NATALIZUMAB, Dosage: INFUSED OVER 1 HOUR, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['tysabri']
|
['natalizumab']
|
['multiple sclerosis']
|
14,654,928
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018044921
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Intestinal ulcer (Recovering / Resolving); Dysphonia (Not Recovered / Not Resolved / Ongoing); Gastrointestinal disorder (Recovering / Resolving); Anal haemorrhage (Recovering / Resolving)
|
ADVAIR HFA (Suspect), Active: FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE, Dosage: 2 PUFF(S), BID, Indication: ASTHMA, Action: Unknown, Additional: Doesn't Apply
|
['advair hfa']
|
['fluticasone propionate\\salmeterol xinafoate']
|
['asthma']
|
14,655,698
| 3
|
China
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
CN-BAYER-2018-006523
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Male
|
Haematuria (Not Recovered / Not Resolved / Ongoing); Oliguria (Not Recovered / Not Resolved / Ongoing); Blood urine present (Recovering / Resolving); Proteinuria (Recovering / Resolving); Heart rate increased (Recovering / Resolving); Blood bilirubin increased (Not Recovered / Not Resolved / Ongoing)
|
STIVARGA (Suspect), Active: REGORAFENIB, Dosage: 120 MG, QD, Indication: COLORECTAL CANCER, Action: Not applicable
|
['stivarga']
|
['regorafenib']
|
['colorectal cancer']
|
14,661,042
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Disabling (Yes)
| 20,180,320
| 20,180,711
|
US-CELGENEUS-USA-20180306489
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Male
|
Arthralgia (Recovering / Resolving); Tremor (Recovering / Resolving); Pain (Recovering / Resolving); Diarrhoea (Recovering / Resolving); Nausea (Recovering / Resolving); Dizziness (Recovering / Resolving)
|
OTEZLA (Suspect), Active: APREMILAST, Dosage: 60 MILLIGRAM, Action: Unknown, Additional: Doesn't Apply; OTEZLA (Suspect), Active: APREMILAST, Dosage: 60 MILLIGRAM, Indication: PSORIASIS, Action: Unknown, Additional: Doesn't Apply
|
['otezla']
|
['apremilast']
|
['psoriasis']
|
14,661,621
| 3
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
JP-009507513-1803JPN001937J
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Male
|
Pneumonia bacterial (Recovering / Resolving); Pyrexia (Recovered / Resolved)
|
KEYTRUDA (Suspect), Active: PEMBROLIZUMAB, Dosage: 200 MG, Q3W, Indication: LUNG ADENOCARCINOMA, Action: Dose not changed
|
['keytruda']
|
['pembrolizumab']
|
['lung adenocarcinoma']
|
14,662,451
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,321
| 20,180,711
|
US-009507513-1803USA007710
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Fatigue (Not Recovered / Not Resolved / Ongoing); Headache (Not Recovered / Not Resolved / Ongoing); Influenza like illness (Not Recovered / Not Resolved / Ongoing)
|
INTRON A (Suspect), Active: INTERFERON ALFA-2B, Dosage: 0.25 ML, TIW, Indication: PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED, Action: Dose not changed
|
['intron a']
|
['interferon alfa-2b']
|
['peripheral t-cell lymphoma unspecified']
|
14,664,122
| 2
|
Japan
|
Spontaneous
|
Yes
|
Disabling (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
JP-ASTRAZENECA-2018SE35036
|
Regulatory Authority
|
FDA-Public Use
| 9,994
|
Day
|
Male
|
Extrapyramidal disorder (Recovering / Resolving)
|
BIPRESSO (QUETIAPINE FUMARATE) (Suspect), Active: QUETIAPINE FUMARATE, Indication: BIPOLAR I DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['bipresso (quetiapine fumarate)']
|
['quetiapine fumarate']
|
['bipolar i disorder']
|
14,652,421
| 4
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,318
| 20,180,711
|
US-ABBVIE-18K-163-2289990-00
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Pyrexia (Not Recovered / Not Resolved / Ongoing); Abdominal distension (Not Recovered / Not Resolved / Ongoing); Intestinal obstruction (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['humira']
|
['adalimumab']
|
['crohn^s disease']
|
14,652,476
| 2
|
Canada
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,318
| 20,180,711
|
CA-ABBVIE-18K-028-2292413-00
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Male
|
Epstein-Barr virus associated lymphoma (Fatal)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: PSORIATIC ARTHROPATHY, Action: Dose not changed
|
['humira']
|
['adalimumab']
|
['psoriatic arthropathy']
|
14,653,487
| 3
|
France
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,319
| 20,180,711
|
FR-ABBVIE-18S-056-2293437-00
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Anaphylactic shock (Fatal)
|
CLARITHROMYCIN. (Suspect), Active: CLARITHROMYCIN, Dosage: 1000 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['clarithromycin.']
|
['clarithromycin']
|
['product used for unknown indication']
|
14,654,359
| 2
|
Mexico
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
MX-CELGENEUS-MEX-20180303664
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Hypersensitivity (Recovered / Resolved); Hypersensitivity (Recovered / Resolved); Drug intolerance (Recovered / Resolved)
|
IMNOVID (Suspect), Active: POMALIDOMIDE, Dosage: 4 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Drug Withdrawn, Additional: Yes; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 25 MILLIGRAM, Action: Dose reduced, Additional: Yes; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 25 MILLIGRAM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose reduced, Additional: Yes
|
['revlimid', 'imnovid']
|
['pomalidomide', 'lenalidomide']
|
['product used for unknown indication', 'plasma cell myeloma']
|
14,655,731
| 3
|
France
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,319
| 20,180,711
|
FR-TEVA-2018-FR-869364
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Blood urine present (Not Recovered / Not Resolved / Ongoing)
|
ESTREVA 0.1 % (Suspect), Active: ESTRADIOL, Dosage: 1 DOSAGE FORMS DAILY;, Action: Dose not changed; ESTREVA 0.1 % (Suspect), Active: ESTRADIOL, Dosage: 1 DOSAGE FORMS DAILY;, Indication: HORMONE REPLACEMENT THERAPY, Action: Dose not changed
|
['estreva 0.1 %']
|
['estradiol']
|
['hormone replacement therapy']
|
14,656,528
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
US-JNJFOC-20180321569
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Death (Fatal)
|
ZYTIGA (Suspect), Active: ABIRATERONE ACETATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['zytiga']
|
['abiraterone acetate']
|
['product used for unknown indication']
|
14,658,297
| 2
|
Germany
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
DE-ORION CORPORATION ORION PHARMA-18_00003237
|
Regulatory Authority
|
FDA-Public Use
| 15
|
Year
|
Male
|
Pneumonia aspiration (Recovered / Resolved); Sinusitis (Recovered / Resolved); Otitis media (Recovered / Resolved); Epilepsy (Recovered / Resolved); Seizure (Recovered / Resolved)
|
PREDNISON (Suspect), Active: PREDNISONE, Indication: STILL^S DISEASE, Action: Unknown, Additional: Doesn't Apply; ROACTEMRA (Suspect), Active: TOCILIZUMAB, Action: Unknown, Additional: Doesn't Apply; ROACTEMRA (Suspect), Active: TOCILIZUMAB, Indication: STILL^S DISEASE, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE (TRADE NAME UNKNOWN) (Suspect), Active: METHOTREXATE, Indication: STILL^S DISEASE, Action: Unknown, Additional: Doesn't Apply; PANTOPRAZOL (Suspect), Active: PANTOPRAZOLE SODIUM, Indication: STILL^S DISEASE, Action: Unknown, Additional: Doesn't Apply; DICLOFENAC (Suspect), Active: DICLOFENAC, Indication: STILL^S DISEASE, Action: Not applicable
|
['roactemra', 'diclofenac', 'prednison', 'methotrexate (trade name unknown)', 'pantoprazol']
|
['tocilizumab', 'methotrexate', 'prednisone', 'diclofenac', 'pantoprazole sodium']
|
['still^s disease']
|
14,658,887
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
PHHY2018US044315
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Vision blurred (Recovered / Resolved); Eye irritation (Recovered / Resolved); Drug ineffective (Recovered / Resolved)
|
SYSTANE BALANCE (Suspect), Active: PROPYLENE GLYCOL, Indication: DRY EYE, Action: Unknown, Additional: Doesn't Apply
|
['systane balance']
|
['propylene glycol']
|
['dry eye']
|
14,658,891
| 3
|
Brazil
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
BR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-014716
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Male
|
Decreased appetite (Not Recovered / Not Resolved / Ongoing); Pulmonary embolism (Not Recovered / Not Resolved / Ongoing); Death (Fatal); Asthenia (Not Recovered / Not Resolved / Ongoing); Dyspnoea (Not Recovered / Not Resolved / Ongoing); Hyperhidrosis (Not Recovered / Not Resolved / Ongoing)
|
OFEV (Suspect), Active: NINTEDANIB, Indication: IDIOPATHIC PULMONARY FIBROSIS, Action: Not applicable
|
['ofev']
|
['nintedanib']
|
['idiopathic pulmonary fibrosis']
|
14,660,218
| 2
|
Canada
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
CA-JNJFOC-20180320463
|
Regulatory Authority
|
FDA-Public Use
| 75
|
Year
|
Female
|
Gastrointestinal tract adenoma (Not Recovered / Not Resolved / Ongoing)
|
REMICADE (Suspect), Active: INFLIXIMAB, Dosage: STRENGTH = 100 MG, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: No; REMICADE (Suspect), Active: INFLIXIMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: No
|
['remicade']
|
['infliximab']
|
['crohn^s disease']
|
14,660,234
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-ELI_LILLY_AND_COMPANY-US201803006634
|
Regulatory Authority
|
FDA-Public Use
| 23
|
Year
|
Male
|
Headache (Not Recovered / Not Resolved / Ongoing); Respiratory symptom (Not Recovered / Not Resolved / Ongoing); Aphonia (Not Recovered / Not Resolved / Ongoing)
|
TALTZ (Suspect), Active: IXEKIZUMAB, Dosage: 160 MG, LOADING DOSE, Indication: PSORIASIS, Action: Unknown, Additional: Doesn't Apply; TALTZ (Suspect), Active: IXEKIZUMAB, Dosage: 80 MG, EVERY TWO WEEKS, Action: Unknown, Additional: Doesn't Apply
|
['taltz']
|
['ixekizumab']
|
['psoriasis']
|
14,660,254
| 3
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,320
| 20,180,711
|
GB-EMD SERONO-E2B_90016866
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Male
|
Pneumonitis (Fatal)
|
AVELUMAB (Suspect), Active: AVELUMAB, Dosage: 350 MG, EVERY 2 WEEKS, Indication: HODGKIN^S DISEASE, Action: Drug Withdrawn
|
['avelumab']
|
['avelumab']
|
['hodgkin^s disease']
|
14,661,100
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,320
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018046718
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Female
|
Skin exfoliation (Recovering / Resolving); Injection site bruising (Not Recovered / Not Resolved / Ongoing)
|
BENLYSTA (Suspect), Active: BELIMUMAB, Dosage: 200 MG, WE, Indication: SYSTEMIC LUPUS ERYTHEMATOSUS, Action: Unknown, Additional: Doesn't Apply
|
['benlysta']
|
['belimumab']
|
['systemic lupus erythematosus']
|
14,661,701
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,320
| 20,180,711
|
GB-TAKEDA-2018TUS006826
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Blood uric acid decreased (Recovering / Resolving); Paraesthesia (Not Recovered / Not Resolved / Ongoing); Neuropathy peripheral (Not Recovered / Not Resolved / Ongoing)
|
ADENURIC (Suspect), Active: FEBUXOSTAT, Dosage: 80 MG, QOD, Action: Drug Withdrawn, Additional: Yes; ADENURIC (Suspect), Active: FEBUXOSTAT, Dosage: 80 MG, QD, Indication: GOUT, Action: Drug Withdrawn, Additional: Yes
|
['adenuric']
|
['febuxostat']
|
['gout']
|
14,663,292
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
US-APOTEX-2018AP008315
|
Regulatory Authority
|
FDA-Public Use
| 39
|
Year
|
Male
|
Cytomegalovirus viraemia (Recovered / Resolved); Guillain-Barre syndrome (Recovered / Resolved)
|
MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: 1 G, BID, Indication: IMMUNOSUPPRESSION, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: 8 TO 10 NG/ML, Indication: IMMUNOSUPPRESSION, Action: Unknown, Additional: Doesn't Apply; TACROLIMUS. (Suspect), Active: TACROLIMUS, Dosage: 1.5 MG, BID, Action: Unknown, Additional: Doesn't Apply; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: 500 MG, BID, Action: Unknown, Additional: Doesn't Apply; MYCOPHENOLATE (Suspect), Active: MYCOPHENOLIC ACID, Dosage: 1 G, BID, Action: Unknown, Additional: Doesn't Apply; PREDNISONE. (Suspect), Active: PREDNISONE, Dosage: 5 MG, QD, Indication: IMMUNOSUPPRESSION, Action: Unknown, Additional: Doesn't Apply
|
['tacrolimus.', 'prednisone.', 'mycophenolate']
|
['tacrolimus', 'prednisone', 'mycophenolic acid']
|
['immunosuppression']
|
14,663,293
| 2
|
Canada
|
Other
|
Yes
|
Disabling (Yes)
| 20,180,321
| 20,180,711
|
CA-APOTEX-2018AP007889
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Female
|
Dyspepsia (Recovered / Resolved)
|
CLOPIDOGREL (Suspect), Active: CLOPIDOGREL BISULFATE, Dosage: UNK, Indication: ARTERIOSCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['clopidogrel']
|
['clopidogrel bisulfate']
|
['arteriosclerosis']
|
14,664,181
| 3
|
France
|
Spontaneous
|
Yes
|
Congenital anomaly (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
FR-VIIV HEALTHCARE LIMITED-FR2018043686
|
Regulatory Authority
|
FDA-Public Use
| 1
|
Day
|
Female
|
Foetal exposure during pregnancy (Recovered / Resolved); Atrial septal defect (Recovering / Resolving)
|
PREZISTA (Suspect), Active: DARUNAVIR ETHANOLATE, Dosage: 800 MG, QD, Action: Drug Withdrawn, Additional: Yes; KIVEXA (Suspect), Active: ABACAVIR SULFATE\LAMIVUDINE, Indication: PROPHYLAXIS AGAINST HIV INFECTION, Action: Drug Withdrawn, Additional: Yes; NORVIR (Suspect), Active: RITONAVIR, Dosage: 1 DF, QD, Indication: PROPHYLAXIS AGAINST HIV INFECTION, Action: Drug Withdrawn, Additional: Yes; TRUVADA (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE, Dosage: 200MG/245MG, QD, Indication: PROPHYLAXIS AGAINST HIV INFECTION, Action: Drug Withdrawn, Additional: Yes; TRUVADA (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE, Dosage: 200MG/245MG, QD, Action: Drug Withdrawn, Additional: Yes; PREZISTA (Suspect), Active: DARUNAVIR ETHANOLATE, Dosage: 1 DF, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; NORVIR (Suspect), Active: RITONAVIR, Dosage: 100 MG, QD, Action: Drug Withdrawn, Additional: Yes; KIVEXA (Suspect), Active: ABACAVIR SULFATE\LAMIVUDINE, Dosage: 100 MG, QD, Indication: HIV INFECTION, Action: Drug Withdrawn, Additional: Yes
|
['truvada', 'kivexa', 'prezista', 'norvir']
|
['abacavir sulfate\\lamivudine', 'darunavir ethanolate', 'ritonavir', 'emtricitabine\\tenofovir disoproxil fumarate']
|
['hiv infection', 'product used for unknown indication', 'prophylaxis against hiv infection']
|
14,660,301
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
US-PFIZER INC-2018115536
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Death (Fatal)
|
PRILOSEC (Suspect), Active: OMEPRAZOLE MAGNESIUM, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PREVACID (Suspect), Active: LANSOPRAZOLE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PROTONIX (Suspect), Active: PANTOPRAZOLE SODIUM, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PREVACID 24 HR (Suspect), Active: LANSOPRAZOLE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; NEXIUM (Suspect), Active: ESOMEPRAZOLE MAGNESIUM, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PRILOSEC OTC (Suspect), Active: OMEPRAZOLE MAGNESIUM, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; NEXIUM 24HR (Suspect), Active: ESOMEPRAZOLE MAGNESIUM, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; DEXILANT (Suspect), Active: DEXLANSOPRAZOLE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['protonix', 'prilosec otc', 'nexium 24hr', 'prilosec', 'nexium', 'prevacid 24 hr', 'dexilant', 'prevacid']
|
['lansoprazole', 'esomeprazole magnesium', 'omeprazole magnesium', 'dexlansoprazole', 'pantoprazole sodium']
|
[]
|
14,661,748
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,320
| 20,180,711
|
US-ALLERGAN-1811603US
|
Regulatory Authority
|
FDA-Public Use
| 85
|
Year
|
Female
|
Appendix disorder (Recovered / Resolved); Vision blurred (Recovered / Resolved); Eye haemorrhage (Recovered / Resolved); Erythropsia (Recovered / Resolved); Retinal disorder (Not Recovered / Not Resolved / Ongoing)
|
GELNIQUE (Suspect), Active: OXYBUTYNIN, Dosage: UNK, Indication: BLADDER DISORDER, Action: Drug Withdrawn, Additional: Yes
|
['gelnique']
|
['oxybutynin']
|
['bladder disorder']
|
14,652,561
| 2
|
Netherlands
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
NL-ABBVIE-18K-114-2290579-00
|
Regulatory Authority
|
FDA-Public Use
| 10
|
Month
|
Male
|
Gastroenteritis (Recovered / Resolved)
|
SYNAGIS (Suspect), Active: PALIVIZUMAB, Indication: ANTIVIRAL PROPHYLAXIS, Action: Dose not changed; SYNAGIS (Suspect), Active: PALIVIZUMAB, Action: Dose not changed
|
['synagis']
|
['palivizumab']
|
['antiviral prophylaxis']
|
14,653,558
| 2
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
DE-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-024358
|
Regulatory Authority
|
FDA-Public Use
| 83
|
Year
|
Female
|
Death (Fatal)
|
ELIQUIS (Suspect), Active: APIXABAN, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['eliquis']
|
['apixaban']
|
['product used for unknown indication']
|
14,654,459
| 2
|
Austria
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,319
| 20,180,711
|
AT-BAYER-2018-046372
|
Regulatory Authority
|
FDA-Public Use
| 36
|
Year
|
Female
|
Eye pain (Recovered / Resolved); Visual impairment (Recovered / Resolved); Papilloedema (Recovered / Resolved); Intracranial pressure increased (Recovered / Resolved); Eye irritation (Recovered / Resolved); Headache (Recovered / Resolved); Eye pruritus (Recovered / Resolved); Hemianaesthesia (Recovered / Resolved)
|
MIRENA (Suspect), Active: LEVONORGESTREL, Dosage: 20 MCG/24HR, CONT, Action: Drug Withdrawn, Additional: Yes
|
['mirena']
|
['levonorgestrel']
|
[]
|
12,284,110
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,160,419
| 20,180,711
|
US-BIOGEN-2016BI00223560
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Cold sweat (Recovered / Resolved); Drug hypersensitivity (Recovered / Resolved); Pallor (Recovered / Resolved); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Aphasia (Recovered / Resolved)
|
PLEGRIDY (Suspect), Active: PEGINTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['plegridy']
|
['peginterferon beta-1a']
|
['multiple sclerosis']
|
12,239,818
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,160,405
| 20,180,711
|
US-ROCHE-1697173
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Diarrhoea (Not Recovered / Not Resolved / Ongoing)
|
ERIVEDGE (Suspect), Active: VISMODEGIB, Dosage: TAKE ONE CAPSULE BY MOUTH EVERY DAY, Indication: OESOPHAGEAL CARCINOMA, Action: Unknown, Additional: Doesn't Apply; ERIVEDGE (Suspect), Active: VISMODEGIB, Dosage: USE AS DIRECTED BY PHYSICIAN, Action: Unknown, Additional: Doesn't Apply; ERIVEDGE (Suspect), Active: VISMODEGIB, Indication: BASAL CELL CARCINOMA, Action: Unknown, Additional: Doesn't Apply; ERIVEDGE (Suspect), Active: VISMODEGIB, Dosage: TAKE ONE CAPSULE BY MOUTH EVERY DAY, Action: Unknown, Additional: Doesn't Apply
|
['erivedge']
|
['vismodegib']
|
['basal cell carcinoma', 'oesophageal carcinoma']
|
12,277,502
| 10
|
United States of America
|
Spontaneous
|
No
| null | 20,160,418
| 20,180,711
|
US-ACTELION PHARMACEUTICALS US, INC.-A-NJ2015-128920
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Female
|
Productive cough (Recovered / Resolved); Ear pain (Recovered / Resolved); Throat irritation (Recovered / Resolved); Chronic obstructive pulmonary disease (Recovered / Resolved); Acute sinusitis (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Pyrexia (Recovered / Resolved); Respiratory tract congestion (Recovered / Resolved)
|
OPSUMIT (Suspect), Active: MACITENTAN, Dosage: 10 MG, QD, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Dose not changed
|
['opsumit']
|
['macitentan']
|
['pulmonary arterial hypertension']
|
12,240,615
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,160,406
| 20,180,711
|
US-BIOGEN-2016BI00204227
|
Regulatory Authority
|
FDA-Public Use
| 52
|
Year
|
Female
|
Device malfunction (Recovered / Resolved); Drug dose omission (Recovered / Resolved); Injection site haemorrhage (Recovered / Resolved)
|
PLEGRIDY (Suspect), Active: PEGINTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed
|
['plegridy']
|
['peginterferon beta-1a']
|
['multiple sclerosis']
|
12,240,689
| 13
|
Canada
|
Report from study
|
Yes
|
Other (Yes)
| 20,160,406
| 20,180,711
|
CA-ROCHE-1188566
|
Regulatory Authority
|
FDA-Public Use
| 53
|
Year
|
Female
|
Nasopharyngitis (Recovered / Resolved); Sinusitis (Recovering / Resolving); Lung disorder (Not Recovered / Not Resolved / Ongoing); Infusion related reaction (Recovered / Resolved); Headache (Not Recovered / Not Resolved / Ongoing); Mass (Not Recovered / Not Resolved / Ongoing); Cough (Recovered / Resolved); Arthralgia (Not Recovered / Not Resolved / Ongoing); Vulvovaginal mycotic infection (Not Recovered / Not Resolved / Ongoing); Infusion related reaction (Recovered / Resolved); Ear infection (Not Recovered / Not Resolved / Ongoing); Dyspnoea (Not Recovered / Not Resolved / Ongoing)
|
RITUXAN (Suspect), Active: RITUXIMAB, Action: Dose not changed; RITUXAN (Suspect), Active: RITUXIMAB, Dosage: LAST DOSE: 07/APR/2015, 17/APR/2015, 05/JUN/2015, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['rituxan']
|
['rituximab']
|
['rheumatoid arthritis']
|
12,242,775
| 8
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes); Life-threatening (Yes)
| 20,160,406
| 20,180,711
|
JP-PFIZER INC-2016148793
|
Regulatory Authority
|
FDA-Public Use
| 84
|
Year
|
Male
|
C-reactive protein increased (Recovered / Resolved); Femur fracture (Recovering / Resolving); Lymphocyte count decreased (Recovered / Resolved); Pneumonia (Recovering / Resolving)
|
XELJANZ (Suspect), Active: TOFACITINIB CITRATE, Dosage: 5 MG, 2X/DAY, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['xeljanz']
|
['tofacitinib citrate']
|
['rheumatoid arthritis']
|
12,230,279
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,160,401
| 20,180,711
|
US-JNJFOC-20160308308
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Male
|
Shock haemorrhagic (Fatal); Haematuria (Fatal)
|
XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn; XARELTO (Suspect), Active: RIVAROXABAN, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Drug Withdrawn; ASPIRIN. (Suspect), Active: ASPIRIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn; XARELTO (Suspect), Active: RIVAROXABAN, Indication: THROMBOSIS PROPHYLAXIS, Action: Drug Withdrawn
|
['aspirin.', 'xarelto']
|
['aspirin', 'rivaroxaban']
|
['cerebrovascular accident prophylaxis', 'atrial fibrillation', 'product used for unknown indication', 'thrombosis prophylaxis']
|
12,214,415
| 14
|
Argentina
|
Report from study
|
Yes
|
Other (Yes)
| 20,160,328
| 20,180,711
|
PHHY2015AR079121
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Female
|
Hepatic cyst (Not Recovered / Not Resolved / Ongoing); Decreased immune responsiveness (Not Recovered / Not Resolved / Ongoing); Nasal inflammation (Recovering / Resolving); Influenza (Recovering / Resolving); Hordeolum (Recovered / Resolved); Peripheral swelling (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Recovered / Resolved); Chest discomfort (Not Recovered / Not Resolved / Ongoing); Discomfort (Not Recovered / Not Resolved / Ongoing); Musculoskeletal discomfort (Not Recovered / Not Resolved / Ongoing); Musculoskeletal chest pain (Not Recovered / Not Resolved / Ongoing); Anaemia (Not Recovered / Not Resolved / Ongoing); Abdominal discomfort (Recovering / Resolving); Osteoporosis (Not Recovered / Not Resolved / Ongoing); Dysphonia (Recovering / Resolving); Stomatitis (Recovered / Resolved); Headache (Not Recovered / Not Resolved / Ongoing); Liver induration (Not Recovered / Not Resolved / Ongoing); Rhinalgia (Recovering / Resolving); Constipation (Not Recovered / Not Resolved / Ongoing); Tonsillitis (Recovered / Resolved); Somnolence (Not Recovered / Not Resolved / Ongoing); Skin exfoliation (Not Recovered / Not Resolved / Ongoing); Flatulence (Recovered / Resolved); Malaise (Not Recovered / Not Resolved / Ongoing); Skin mass (Recovered / Resolved); Nail disorder (Recovered / Resolved); Arthralgia (Not Recovered / Not Resolved / Ongoing); Abdominal distension (Recovered / Resolved); Angina pectoris (Recovered / Resolved)
|
AFINITOR (Suspect), Active: EVEROLIMUS, Dosage: 5 MG, QD, Action: Drug Withdrawn, Additional: Yes; AFINITOR (Suspect), Active: EVEROLIMUS, Dosage: 10 MG, QD, Indication: NEUROENDOCRINE TUMOUR, Action: Drug Withdrawn, Additional: Yes; SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 30 MG, QMO, Indication: NEUROENDOCRINE TUMOUR, Action: Dose not changed
|
['afinitor', 'sandostatin lar depot']
|
['everolimus', 'octreotide acetate']
|
['neuroendocrine tumour']
|
12,250,412
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,160,408
| 20,180,711
|
ALCN2016US002412
|
Regulatory Authority
|
FDA-Public Use
| 84
|
Year
|
Female
|
Eye pain (Recovered / Resolved)
|
SYSTANE ULTRA (Suspect), Active: POLYETHYLENE GLYCOL 400\PROPYLENE GLYCOL, Dosage: 1 GTT, BID, Indication: DRY EYE, Action: Drug Withdrawn, Additional: Yes
|
['systane ultra']
|
['polyethylene glycol 400\\propylene glycol']
|
['dry eye']
|
13,206,513
| 5
|
United States of America
|
Spontaneous
|
No
| null | 20,170,209
| 20,180,711
|
US-SA-2016SA202809
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Female
|
Lipoma (Not Recovered / Not Resolved / Ongoing); Muscle spasms (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Not Recovered / Not Resolved / Ongoing); Sinusitis (Not Recovered / Not Resolved / Ongoing); Cough (Recovering / Resolving)
|
ALIROCUMAB PREFILLED PEN (Suspect), Active: ALIROCUMAB, Indication: HYPERCHOLESTEROLAEMIA, Action: Dose not changed; PRALUENT (Suspect), Active: ALIROCUMAB, Indication: HYPERCHOLESTEROLAEMIA, Action: Dose not changed
|
['alirocumab prefilled pen', 'praluent']
|
['alirocumab']
|
['hypercholesterolaemia']
|
13,233,355
| 8
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,170,215
| 20,180,711
|
GB-TEVA-738229ACC
|
Regulatory Authority
|
FDA-Public Use
| 85
|
Year
|
Male
|
Neutropenic sepsis (Fatal); Diarrhoea (Recovered / Resolved with Sequelae); Lethargy (Recovered / Resolved with Sequelae); Dementia Alzheimer^s type (Fatal); Productive cough (Recovered / Resolved with Sequelae); Decreased appetite (Recovered / Resolved with Sequelae)
|
BENDAMUSTINE HYDROCHLORIDE. (Suspect), Active: BENDAMUSTINE HYDROCHLORIDE, Dosage: (PER PROTOCOL), Indication: CHRONIC LYMPHOCYTIC LEUKAEMIA, Action: Not applicable; OFATUMUMAB (Suspect), Active: OFATUMUMAB, Dosage: 1000 MG, PER PROTOCOL, Indication: CHRONIC LYMPHOCYTIC LEUKAEMIA, Action: Not applicable
|
['ofatumumab', 'bendamustine hydrochloride.']
|
['bendamustine hydrochloride', 'ofatumumab']
|
['chronic lymphocytic leukaemia']
|
13,207,270
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,170,209
| 20,180,711
|
US-SA-2016SA233796
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Rhinorrhoea (Recovering / Resolving); Pain (Recovering / Resolving)
|
ALIROCUMAB PREFILLED SYRINGE (Suspect), Active: ALIROCUMAB, Indication: TYPE V HYPERLIPIDAEMIA, Action: Dose not changed; PRALUENT (Suspect), Active: ALIROCUMAB, Indication: TYPE V HYPERLIPIDAEMIA, Action: Dose not changed
|
['praluent', 'alirocumab prefilled syringe']
|
['alirocumab']
|
['type v hyperlipidaemia']
|
13,233,683
| 5
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,170,215
| 20,180,711
|
JP-ROCHE-1893370
|
Regulatory Authority
|
FDA-Public Use
| 8
|
Year
|
Male
|
Influenza (Recovered / Resolved); Febrile neutropenia (Recovered / Resolved); Upper respiratory tract inflammation (Recovered / Resolved); Vernal keratoconjunctivitis (Recovered / Resolved)
|
RITUXIMAB. (Suspect), Active: RITUXIMAB, Indication: NEPHROTIC SYNDROME, Action: Not applicable; MIZORIBINE (Suspect), Active: MIZORIBINE, Indication: NEPHROTIC SYNDROME, Action: Unknown, Additional: Doesn't Apply; CICLOSPORIN (Suspect), Active: CYCLOSPORINE, Indication: NEPHROTIC SYNDROME, Action: Unknown, Additional: Doesn't Apply; RITUXIMAB. (Suspect), Active: RITUXIMAB, Action: Not applicable
|
['mizoribine', 'rituximab.', 'ciclosporin']
|
['cyclosporine', 'mizoribine', 'rituximab']
|
['nephrotic syndrome']
|
13,244,463
| 4
|
Canada
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,170,217
| 20,180,711
|
CA-TAKEDA-2016TUS000831
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Female
|
Gastroenteritis viral (Recovered / Resolved); Poor venous access (Recovered / Resolved); Constipation (Not Recovered / Not Resolved / Ongoing); Influenza (Recovered / Resolved); Discomfort (Not Recovered / Not Resolved / Ongoing); Abdominal distension (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Not Recovered / Not Resolved / Ongoing)
|
VEDOLIZUMAB (Suspect), Active: VEDOLIZUMAB, Dosage: 300 MG, UNK, Indication: CROHN^S DISEASE, Action: Dose not changed; VEDOLIZUMAB (Suspect), Active: VEDOLIZUMAB, Dosage: 300 MG, Q4WEEKS, Action: Dose not changed
|
['vedolizumab']
|
['vedolizumab']
|
['crohn^s disease']
|
13,210,489
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,170,210
| 20,180,711
|
GB-JNJFOC-20170208653
|
Regulatory Authority
|
FDA-Public Use
| 16
|
Year
|
Male
|
Epistaxis (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing); Decreased appetite (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing); Influenza like illness (Not Recovered / Not Resolved / Ongoing); Nasal congestion (Not Recovered / Not Resolved / Ongoing); Oropharyngeal pain (Not Recovered / Not Resolved / Ongoing); Discomfort (Not Recovered / Not Resolved / Ongoing); Depression (Not Recovered / Not Resolved / Ongoing); Sneezing (Not Recovered / Not Resolved / Ongoing); Nasal inflammation (Not Recovered / Not Resolved / Ongoing)
|
TOPIRAMATE. (Suspect), Active: TOPIRAMATE, Dosage: 50 (UNSPECIFIED UNITS), Indication: MIGRAINE PROPHYLAXIS, Action: Drug Withdrawn, Additional: No
|
['topiramate.']
|
['topiramate']
|
['migraine prophylaxis']
|
13,226,704
| 5
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,170,213
| 20,180,711
|
US-JNJFOC-20170208158
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Male
|
Diabetic ketoacidosis (Fatal); Acute kidney injury (Fatal)
|
INVOKANA (Suspect), Active: CANAGLIFLOZIN, Indication: TYPE 2 DIABETES MELLITUS, Action: Drug Withdrawn; METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn
|
['metformin', 'invokana']
|
['canagliflozin', 'metformin hydrochloride']
|
['type 2 diabetes mellitus', 'product used for unknown indication']
|
13,227,543
| 2
|
Brazil
|
Report from study
|
Yes
|
Other (Yes)
| 20,170,213
| 20,180,711
|
PHHY2017BR020696
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Amnesia (Not Recovered / Not Resolved / Ongoing)
|
EXELON PATCH (Suspect), Active: RIVASTIGMINE, Dosage: 9.5 MG, QD PATCH 10 (CM2), Indication: DEMENTIA ALZHEIMER^S TYPE, Action: Dose not changed; EXELON PATCH (Suspect), Active: RIVASTIGMINE, Dosage: 13.3 MG, QD (EXELON 15 CM2 PATCH), Action: Dose not changed
|
['exelon patch']
|
['rivastigmine']
|
['dementia alzheimer^s type']
|
13,230,617
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,170,214
| 20,180,711
|
US-PFIZER INC-2017063196
|
Regulatory Authority
|
FDA-Public Use
| 63
|
Year
|
Male
|
Nasopharyngitis (Not Recovered / Not Resolved / Ongoing)
|
RAPAMUNE (Suspect), Active: SIROLIMUS, Dosage: 2 MG, ONCE A DAY, Action: Dose not changed
|
['rapamune']
|
['sirolimus']
|
[]
|
13,216,408
| 2
|
Brazil
|
Report from study
|
Yes
|
Other (Yes)
| 20,170,210
| 20,180,711
|
BR-ROCHE-1891659
|
Regulatory Authority
|
FDA-Public Use
| 45
|
Year
|
Female
|
Choking (Recovering / Resolving); Aspiration (Recovering / Resolving); Dyspnoea (Recovering / Resolving)
|
XOLAIR (Suspect), Active: OMALIZUMAB, Dosage: 150 MG, QMO, Indication: ASTHMA, Action: Dose not changed; XOLAIR (Suspect), Active: OMALIZUMAB, Dosage: UNK, Action: Dose not changed
|
['xolair']
|
['omalizumab']
|
['asthma']
|
13,239,846
| 4
|
United States of America
|
Spontaneous
|
No
| null | 20,170,216
| 20,180,711
|
US-PFIZER INC-2017062401
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Male
|
Diarrhoea (Not Recovered / Not Resolved / Ongoing); Nausea (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing)
|
SUTENT (Suspect), Active: SUNITINIB MALATE, Dosage: 50 MG, CYCLIC (ONCE DAILY FOR 4 WEEKS ON, 2 WEEKS OFF), Indication: RENAL CANCER, Action: Dose not changed
|
['sutent']
|
['sunitinib malate']
|
['renal cancer']
|
13,218,243
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,170,210
| 20,180,711
|
US-ACORDA-ACO_122941_2016
|
Regulatory Authority
|
FDA-Public Use
| 41
|
Year
|
Female
|
Abdominal hernia (Recovered / Resolved); Abdominal hernia obstructive (Recovered / Resolved); Impaired gastric emptying (Not Recovered / Not Resolved / Ongoing)
|
AUBAGIO (Suspect), Active: TERIFLUNOMIDE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; AMPYRA (Suspect), Active: DALFAMPRIDINE, Dosage: 10 MG, BID, Indication: MULTIPLE SCLEROSIS, Action: Dose not changed; AMPYRA (Suspect), Active: DALFAMPRIDINE, Dosage: 10 MG, BID, Indication: MUSCLE SPASTICITY, Action: Dose not changed; AMPYRA (Suspect), Active: DALFAMPRIDINE, Dosage: 10 MG, BID, Indication: GAIT DISTURBANCE, Action: Dose not changed
|
['ampyra', 'aubagio']
|
['dalfampridine', 'teriflunomide']
|
['product used for unknown indication', 'muscle spasticity', 'gait disturbance', 'multiple sclerosis']
|
13,828,506
| 5
|
United States of America
|
Spontaneous
|
No
| null | 20,170,803
| 20,180,711
|
US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-068007
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Anaemia (Not Recovered / Not Resolved / Ongoing)
|
SPRYCEL (Suspect), Active: DASATINIB, Dosage: 1 TAB, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No; SPRYCEL (Suspect), Active: DASATINIB, Dosage: 80 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['sprycel']
|
['dasatinib']
|
['product used for unknown indication']
|
13,829,095
| 3
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,170,803
| 20,180,711
|
JP-PFIZER INC-2015451397
|
Regulatory Authority
|
FDA-Public Use
| 38
|
Year
|
Female
|
Periodontitis (Recovered / Resolved)
|
XELJANZ (Suspect), Active: TOFACITINIB CITRATE, Dosage: 5 MG, 2X/DAY, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: Yes; RHEUMATREX (Suspect), Active: METHOTREXATE SODIUM, Dosage: 10 MG, WEEKLY, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed; RHEUMATREX (Suspect), Active: METHOTREXATE SODIUM, Dosage: 8 MG, WEEKLY, Action: Dose not changed
|
['rheumatrex', 'xeljanz']
|
['methotrexate sodium', 'tofacitinib citrate']
|
['rheumatoid arthritis']
|
13,829,248
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,170,803
| 20,180,711
|
US-ASTRAZENECA-2017SE78654
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Off label use (Not Recovered / Not Resolved / Ongoing); Intentional product misuse (Not Recovered / Not Resolved / Ongoing); Wrong technique in product usage process (Not Recovered / Not Resolved / Ongoing)
|
TUDORZA PRESSAIR (Suspect), Active: ACLIDINIUM BROMIDE, Action: Dose not changed
|
['tudorza pressair']
|
['aclidinium bromide']
|
[]
|
13,809,929
| 4
|
United States of America
|
Report from study
|
No
| null | 20,170,728
| 20,180,711
|
US-AMGEN-USASL2017085408
|
Regulatory Authority
|
FDA-Public Use
| 44
|
Year
|
Male
|
Dizziness (Recovered / Resolved)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: HYPERLIPIDAEMIA, Action: Unknown, Additional: Doesn't Apply; REPATHA (Suspect), Active: EVOLOCUMAB, Indication: ARTERIOSCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['hyperlipidaemia', 'arteriosclerosis']
|
13,812,276
| 4
|
United States of America
|
Report from study
|
No
| null | 20,170,728
| 20,180,711
|
US-AMGEN-USASL2017100870
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Myalgia (Recovering / Resolving)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: BLOOD CHOLESTEROL INCREASED, Action: Dose not changed; PROLIA (Suspect), Active: DENOSUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable; REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 420 MG, QMO, Action: Dose not changed
|
['repatha', 'prolia']
|
['denosumab', 'evolocumab']
|
['blood cholesterol increased', 'product used for unknown indication']
|
13,820,913
| 3
|
Canada
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,170,801
| 20,180,711
|
CA-PFIZER INC-2017331348
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Loss of personal independence in daily activities (Not Recovered / Not Resolved / Ongoing); Pain (Not Recovered / Not Resolved / Ongoing); Thrombocytosis (Not Recovered / Not Resolved / Ongoing); Hand deformity (Not Recovered / Not Resolved / Ongoing); Drug ineffective (Not Recovered / Not Resolved / Ongoing); C-reactive protein increased (Not Recovered / Not Resolved / Ongoing); Anaemia (Not Recovered / Not Resolved / Ongoing); Back disorder (Not Recovered / Not Resolved / Ongoing); Joint swelling (Not Recovered / Not Resolved / Ongoing); Neck mass (Not Recovered / Not Resolved / Ongoing); Pain in extremity (Not Recovered / Not Resolved / Ongoing); Peripheral swelling (Not Recovered / Not Resolved / Ongoing); Joint range of motion decreased (Not Recovered / Not Resolved / Ongoing); Musculoskeletal stiffness (Not Recovered / Not Resolved / Ongoing); Arthralgia (Not Recovered / Not Resolved / Ongoing); Blood albumin decreased (Not Recovered / Not Resolved / Ongoing); Lymphadenopathy (Not Recovered / Not Resolved / Ongoing)
|
ORENCIA (Suspect), Active: ABATACEPT, Dosage: 125 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Action: Unknown, Additional: Doesn't Apply; CIMZIA (Suspect), Active: CERTOLIZUMAB PEGOL, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; PREDNISONE. (Suspect), Active: PREDNISONE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; NAPROSYN (Suspect), Active: NAPROXEN, Dosage: 500 MG, BID, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply; SULFASALAZINE. (Suspect), Active: SULFASALAZINE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Dosage: 25 MG, QWK, Action: Unknown, Additional: Doesn't Apply; PLAQUENIL (Suspect), Active: HYDROXYCHLOROQUINE SULFATE, Dosage: UNK, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['plaquenil', 'orencia', 'enbrel', 'naprosyn', 'sulfasalazine.', 'methotrexate sodium.', 'prednisone.', 'cimzia']
|
['etanercept', 'abatacept', 'hydroxychloroquine sulfate', 'methotrexate sodium', 'naproxen', 'prednisone', 'sulfasalazine', 'certolizumab pegol']
|
['rheumatoid arthritis']
|
13,814,971
| 3
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,170,731
| 20,180,711
|
US-ACADIA PHARMACEUTICALS INC.-ACA-2017-004797
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Male
|
Abnormal loss of weight (Not Recovered / Not Resolved / Ongoing); Eating disorder (Not Recovered / Not Resolved / Ongoing); Intracranial aneurysm (Fatal)
|
NUPLAZID (Suspect), Active: PIMAVANSERIN TARTRATE, Dosage: 17 MG, BID, Action: Not applicable; NUPLAZID (Suspect), Active: PIMAVANSERIN TARTRATE, Dosage: 34 MG, QD, Indication: PARKINSON^S DISEASE, Action: Not applicable
|
['nuplazid']
|
['pimavanserin tartrate']
|
['parkinson^s disease']
|
13,825,854
| 2
|
Ireland
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,170,802
| 20,180,711
|
IE-VERTEX PHARMACEUTICALS-2017-003878
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Chronic kidney disease (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing)
|
ORKAMBI (Suspect), Active: IVACAFTOR\LUMACAFTOR, Indication: CYSTIC FIBROSIS, Action: Unknown, Additional: Doesn't Apply
|
['orkambi']
|
['ivacaftor\\lumacaftor']
|
['cystic fibrosis']
|
13,821,322
| 3
|
United States of America
|
Report from study
|
Yes
|
Death (Yes)
| 20,170,801
| 20,180,711
|
US-BIOGEN-2017BI00439344
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Death (Fatal)
|
TYSABRI (Suspect), Active: NATALIZUMAB, Indication: MULTIPLE SCLEROSIS, Action: Not applicable
|
['tysabri']
|
['natalizumab']
|
['multiple sclerosis']
|
10,168,334
| 8
|
Brazil
|
Report from study
|
Yes
|
Disabling (Yes); Hospitalization (Yes); Other (Yes)
| 20,140,512
| 20,180,711
|
PHHY2014BR056876
|
Regulatory Authority
|
FDA-Public Use
| 82
|
Year
|
Female
|
Condition aggravated (Recovering / Resolving); Weight fluctuation (Recovering / Resolving); Gait disturbance (Not Recovered / Not Resolved / Ongoing); Pneumonia (Recovered / Resolved); Dementia Alzheimer^s type (Recovering / Resolving); Hydrocephalus (Recovering / Resolving); Paroxysmal arrhythmia (Recovered / Resolved); Speech disorder (Recovering / Resolving); Cerebrovascular accident (Recovered / Resolved); Immunodeficiency (Recovered / Resolved); Infusion site rash (Not Recovered / Not Resolved / Ongoing); Movement disorder (Recovered / Resolved with Sequelae); Thrombosis (Recovering / Resolving); Limb mass (Recovered / Resolved); Skin discolouration (Recovered / Resolved)
|
EXELON PATCH (Suspect), Active: RIVASTIGMINE, Dosage: 9.5 MG, QD (PATCH 10 CM2 ), Indication: DEMENTIA ALZHEIMER^S TYPE, Action: Dose not changed; ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 1 DF (5MG/100ML), Q12MO, Indication: OSTEOPOROSIS, Action: Not applicable; ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 1 DF (5MG/100ML), Q12MO, Action: Not applicable; ACLASTA (Suspect), Active: ZOLEDRONIC ACID, Dosage: 1 DF, Q12MO, Action: Not applicable
|
['exelon patch', 'aclasta']
|
['rivastigmine', 'zoledronic acid']
|
['dementia alzheimer^s type', 'osteoporosis']
|
10,169,431
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,140,513
| 20,180,711
|
US-PFIZER INC-2014129881
|
Regulatory Authority
|
FDA-Public Use
| 64
|
Year
|
Female
|
Drug hypersensitivity (Not Recovered / Not Resolved / Ongoing); Myalgia (Not Recovered / Not Resolved / Ongoing)
|
LIPITOR (Suspect), Active: ATORVASTATIN CALCIUM, Dosage: UNK, Action: Drug Withdrawn, Additional: No
|
['lipitor']
|
['atorvastatin calcium']
|
[]
|
14,670,529
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
US-JAZZ-2018-US-004817
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Death (Fatal)
|
XYREM (Suspect), Active: SODIUM OXYBATE, Dosage: 2.25 G, BID, Indication: NARCOLEPSY, Action: Not applicable
|
['xyrem']
|
['sodium oxybate']
|
['narcolepsy']
|
14,674,424
| 2
|
Spain
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,323
| 20,180,711
|
ES-JNJFOC-20180328939
|
Regulatory Authority
|
FDA-Public Use
| 83
|
Year
|
Male
|
Pelvic venous thrombosis (Recovered / Resolved with Sequelae)
|
RIVAROXABAN (Suspect), Active: RIVAROXABAN, Indication: EMBOLISM VENOUS, Action: Drug Withdrawn, Additional: Yes; RIVAROXABAN (Suspect), Active: RIVAROXABAN, Indication: ANTIPHOSPHOLIPID SYNDROME, Action: Drug Withdrawn, Additional: Yes
|
['rivaroxaban']
|
['rivaroxaban']
|
['antiphospholipid syndrome', 'embolism venous']
|
14,676,605
| 2
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,324
| 20,180,711
|
JP-ROCHE-2092617
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
White blood cell count decreased (Recovered / Resolved)
|
XOLAIR (Suspect), Active: OMALIZUMAB, Indication: ASTHMA, Action: Drug Withdrawn, Additional: Yes; XOLAIR (Suspect), Active: OMALIZUMAB, Action: Drug Withdrawn, Additional: Yes
|
['xolair']
|
['omalizumab']
|
['asthma']
|
14,664,923
| 2
|
Brazil
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,321
| 20,180,711
|
BR-SA-2018SA080609
|
Regulatory Authority
|
FDA-Public Use
| 32
|
Year
|
Male
|
Hypothermia (Recovered / Resolved); Hypotension (Recovered / Resolved)
|
THYMOGLOBULINE (Suspect), Active: LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN, Indication: IMMUNOSUPPRESSION, Action: Dose not changed
|
['thymoglobuline']
|
['lapine t-lymphocyte immune globulin']
|
['immunosuppression']
|
14,666,732
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
US-AMGEN-USASP2018038329
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Palpitations (Recovered / Resolved)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
|
['enbrel']
|
['etanercept']
|
['product used for unknown indication']
|
14,671,597
| 2
|
Brazil
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
BR-ROCHE-2089258
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Breast cancer recurrent (Recovered / Resolved)
|
HERCEPTIN (Suspect), Active: TRASTUZUMAB, Indication: BREAST CANCER, Action: Unknown, Additional: Doesn't Apply; HERCEPTIN (Suspect), Active: TRASTUZUMAB, Indication: ADJUVANT THERAPY, Action: Unknown, Additional: Doesn't Apply
|
['herceptin']
|
['trastuzumab']
|
['adjuvant therapy', 'breast cancer']
|
14,675,697
| 2
|
Canada
|
Report from study
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
CA-ABBVIE-18P-028-2295820-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Confusional state (Not Recovered / Not Resolved / Ongoing); Disease progression (Fatal); Decreased appetite (Not Recovered / Not Resolved / Ongoing)
|
VENCLEXTA (Suspect), Active: VENETOCLAX, Indication: CHRONIC LYMPHOCYTIC LEUKAEMIA, Action: Not applicable
|
['venclexta']
|
['venetoclax']
|
['chronic lymphocytic leukaemia']
|
14,675,716
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
US-ABBVIE-18K-163-2297965-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Eye swelling (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Action: Drug Withdrawn, Additional: No; HUMIRA (Suspect), Active: ADALIMUMAB, Indication: UVEITIS, Action: Drug Withdrawn, Additional: No
|
['humira']
|
['adalimumab']
|
['uveitis']
|
14,666,794
| 2
|
Hungary
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,322
| 20,180,711
|
HU-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-015873
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Shock haemorrhagic (Fatal); Duodenal ulcer haemorrhage (Fatal)
|
PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn
|
['pradaxa']
|
['dabigatran etexilate mesylate']
|
['atrial fibrillation']
|
14,670,609
| 3
|
United States of America
|
Spontaneous
|
No
| null | 20,180,322
| 20,180,711
|
US-BIOGEN-2018BI00518623
|
Regulatory Authority
|
FDA-Public Use
| 51
|
Year
|
Female
|
Stress (Not Recovered / Not Resolved / Ongoing); Palpitations (Recovered / Resolved); Anxiety (Not Recovered / Not Resolved / Ongoing); Drug dose omission (Recovered / Resolved); Angina pectoris (Recovered / Resolved); Influenza like illness (Recovered / Resolved); Irritability (Recovered / Resolved); Depression (Recovered / Resolved); Cardiac discomfort (Recovered / Resolved); Injection site haemorrhage (Recovered / Resolved)
|
AVONEX (Suspect), Active: INTERFERON BETA-1A, Action: Unknown, Additional: Doesn't Apply; AVONEX (Suspect), Active: INTERFERON BETA-1A, Indication: MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['avonex']
|
['interferon beta-1a']
|
['multiple sclerosis']
|
14,671,717
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,323
| 20,180,711
|
US-APOTEX-2018AP008780
|
Regulatory Authority
|
FDA-Public Use
| 42
|
Year
|
Female
|
Hepatic failure (Recovered / Resolved); Aspartate aminotransferase increased (Recovered / Resolved); Alanine aminotransferase increased (Recovered / Resolved)
|
IMATINIB MESYLATE TABLETS (Suspect), Active: IMATINIB MESYLATE, Indication: PHILADELPHIA CHROMOSOME POSITIVE, Action: Drug Withdrawn, Additional: Yes; DASATINIB. (Suspect), Active: DASATINIB, Dosage: UNK, Indication: PHILADELPHIA CHROMOSOME POSITIVE, Action: Drug Withdrawn, Additional: Yes; IMATINIB MESYLATE TABLETS (Suspect), Active: IMATINIB MESYLATE, Dosage: UNK, Indication: CHRONIC MYELOID LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes; DASATINIB. (Suspect), Active: DASATINIB, Indication: CHRONIC MYELOID LEUKAEMIA, Action: Drug Withdrawn, Additional: Yes
|
['imatinib mesylate tablets', 'dasatinib.']
|
['dasatinib', 'imatinib mesylate']
|
['philadelphia chromosome positive', 'chronic myeloid leukaemia']
|
14,675,801
| 6
|
Netherlands
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,323
| 20,180,711
|
PHHY2018NL049966
|
Regulatory Authority
|
FDA-Public Use
| 46
|
Year
|
Female
|
Sensory disturbance (Recovered / Resolved with Sequelae); Multiple sclerosis relapse (Recovered / Resolved with Sequelae); Headache (Recovering / Resolving); Neuralgia (Recovering / Resolving)
|
PREDNISOLON (Suspect), Active: PREDNISOLONE, Dosage: UNK, Indication: MULTIPLE SCLEROSIS RELAPSE, Action: Drug Withdrawn, Additional: Yes; COPAXONE (Suspect), Active: GLATIRAMER ACETATE, Dosage: 20 MG/ML, QD, Indication: MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply; AMITRIPTYLINE (Suspect), Active: AMITRIPTYLINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['amitriptyline', 'copaxone', 'prednisolon']
|
['prednisolone', 'amitriptyline', 'glatiramer acetate']
|
['product used for unknown indication', 'multiple sclerosis', 'multiple sclerosis relapse']
|
14,665,019
| 3
|
Mexico
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,321
| 20,180,711
|
PHHY2018MX043436
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Male
|
Blood pressure increased (Not Recovered / Not Resolved / Ongoing); Pneumonia (Recovered / Resolved); Dysphonia (Recovered / Resolved); Fluid retention (Not Recovered / Not Resolved / Ongoing); Expired product administered (Recovered / Resolved)
|
ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 2 DF (200MG, 97MG OF SACUBITRIL AND 103MG OF VALSARTAN), Q12H, Indication: BLOOD PRESSURE INCREASED, Action: Dose not changed; CARBAMAZEPINE. (Suspect), Active: CARBAMAZEPINE, Dosage: 1 DF, Q12H, Indication: RESTLESSNESS, Action: Unknown, Additional: Doesn't Apply; METOPROLOL. (Suspect), Active: METOPROLOL, Dosage: 1 DF, Q12H, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['metoprolol.', 'entresto', 'carbamazepine.']
|
['carbamazepine', 'metoprolol', 'sacubitril\\valsartan']
|
['blood pressure increased', 'product used for unknown indication', 'restlessness']
|
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