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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
14,681,344
| 2
|
Australia
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
AU-ABBVIE-18P-008-2293872-00
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Male
|
Intestinal pseudo-obstruction (Recovered / Resolved)
|
BORTEZOMIB (Suspect), Active: BORTEZOMIB, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; VENCLYXTO (Suspect), Active: VENETOCLAX, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['venclyxto', 'bortezomib', 'dexamethasone.']
|
['venetoclax', 'bortezomib', 'dexamethasone']
|
['product used for unknown indication', 'plasma cell myeloma']
|
14,682,601
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-AMGEN-USASP2018038984
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Spinal operation (Not Recovered / Not Resolved / Ongoing); Osteonecrosis of jaw (Recovered / Resolved)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: UNK, Indication: OSTEOPOROSIS POSTMENOPAUSAL, Action: Drug Withdrawn, Additional: Yes
|
['prolia']
|
['denosumab']
|
['osteoporosis postmenopausal']
|
14,683,275
| 2
|
United States of America
|
Report from study
|
No
| null | 20,180,327
| 20,180,711
|
US-TEVA-2018-US-875846
|
Regulatory Authority
|
FDA-Public Use
| 17
|
Year
| null |
Depression (Recovered / Resolved)
|
CLARAVIS (Suspect), Active: ISOTRETINOIN, Action: Drug Withdrawn, Additional: Yes
|
['claravis']
|
['isotretinoin']
|
[]
|
14,683,941
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-AMGEN-USASP2018038992
|
Regulatory Authority
|
FDA-Public Use
| 86
|
Year
|
Female
|
Tibia fracture (Recovering / Resolving)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
|
['prolia']
|
['denosumab']
|
['product used for unknown indication']
|
14,684,502
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-TESARO, INC-US-2018TSO00569
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Constipation (Not Recovered / Not Resolved / Ongoing); Sleep disorder (Recovered / Resolved); Carbohydrate antigen 125 increased (Not Recovered / Not Resolved / Ongoing); Gastrooesophageal reflux disease (Not Recovered / Not Resolved / Ongoing); Platelet count decreased (Not Recovered / Not Resolved / Ongoing); Blood pressure increased (Not Recovered / Not Resolved / Ongoing)
|
ZEJULA (Suspect), Active: NIRAPARIB, Dosage: 300 MG, QD, Indication: MALIGNANT PERITONEAL NEOPLASM, Action: Drug Withdrawn, Additional: Yes; ZEJULA (Suspect), Active: NIRAPARIB, Dosage: 300 MG, QD, Action: Drug Withdrawn, Additional: Yes
|
['zejula']
|
['niraparib']
|
['malignant peritoneal neoplasm']
|
14,685,652
| 4
|
India
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
IN-PFIZER INC-2018123050
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Gastritis (Recovered / Resolved)
|
FILGOTINIB (Suspect), Active: FILGOTINIB, Dosage: 200 MG, DAILY, Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Dosage: 2.5 MG, WEEKLY (2.5 MG,1 IN 1 W), Indication: RHEUMATOID ARTHRITIS, Action: Dose not changed
|
['methotrexate sodium.', 'filgotinib']
|
['methotrexate sodium', 'filgotinib']
|
['rheumatoid arthritis']
|
14,687,178
| 2
|
Costa Rica
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,328
| 20,180,711
|
CR-ROCHE-2095447
|
Regulatory Authority
|
FDA-Public Use
| 39
|
Year
|
Female
|
Rash (Not Recovered / Not Resolved / Ongoing); Drug hypersensitivity (Not Recovered / Not Resolved / Ongoing); Pruritus (Not Recovered / Not Resolved / Ongoing); Blister (Not Recovered / Not Resolved / Ongoing); Burning sensation (Not Recovered / Not Resolved / Ongoing)
|
XOLAIR (Suspect), Active: OMALIZUMAB, Indication: ASTHMA, Action: Unknown, Additional: Doesn't Apply; XOLAIR (Suspect), Active: OMALIZUMAB, Action: Unknown, Additional: Doesn't Apply; MONTELUKAST SODIUM. (Suspect), Active: MONTELUKAST SODIUM, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['xolair', 'montelukast sodium.']
|
['omalizumab', 'montelukast sodium']
|
['asthma', 'product used for unknown indication']
|
14,679,123
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
US-AMAG PHARMACEUTICALS, INC.-AMAG201800792
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Influenza (Recovered / Resolved); Pneumonia (Recovered / Resolved); Cholestasis (Not Recovered / Not Resolved / Ongoing); Rash pruritic (Recovered / Resolved)
|
MAKENA (Suspect), Active: HYDROXYPROGESTERONE CAPROATE, Dosage: 250 MG/ML, WEEKLY, Indication: PREMATURE DELIVERY, Action: Drug Withdrawn, Additional: Yes
|
['makena']
|
['hydroxyprogesterone caproate']
|
['premature delivery']
|
14,680,509
| 2
|
Netherlands
|
Report from study
|
No
| null | 20,180,326
| 20,180,711
|
NL-ABBVIE-18S-114-2295102-00
|
Regulatory Authority
|
FDA-Public Use
| 37
|
Year
|
Female
|
Drug hypersensitivity (Recovered / Resolved); Pruritus (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Drug hypersensitivity (Recovered / Resolved); Pruritus (Recovered / Resolved)
|
LUCRIN DEPOT (Suspect), Active: LEUPROLIDE ACETATE, Indication: BREAST CANCER, Action: Dose not changed; LUCRIN DEPOT (Suspect), Active: LEUPROLIDE ACETATE, Action: Dose not changed
|
['lucrin depot']
|
['leuprolide acetate']
|
['breast cancer']
|
14,679,848
| 2
|
France
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
FR-BRISTOL-MYERS SQUIBB COMPANY-BMS-2017-109607
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Female
|
Back pain (Recovered / Resolved); Oedema peripheral (Recovered / Resolved); Arthralgia (Not Recovered / Not Resolved / Ongoing); Haemoptysis (Recovered / Resolved)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 187 MG, Q2WK, Indication: LUNG NEOPLASM MALIGNANT, Action: Drug Withdrawn, Additional: Yes
|
['nivolumab']
|
['nivolumab']
|
['lung neoplasm malignant']
|
14,680,593
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018049243
|
Regulatory Authority
|
FDA-Public Use
| 22
|
Year
|
Female
|
Rash (Not Recovered / Not Resolved / Ongoing); Malaise (Not Recovered / Not Resolved / Ongoing); Pyrexia (Not Recovered / Not Resolved / Ongoing); Rash generalised (Not Recovered / Not Resolved / Ongoing)
|
LAMOTRIGINE TABLET (Suspect), Active: LAMOTRIGINE, Dosage: 25 MG, QD, Indication: DEPRESSION, Action: Drug Withdrawn, Additional: No
|
['lamotrigine tablet']
|
['lamotrigine']
|
['depression']
|
14,681,404
| 2
|
Italy
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
IT-VALIDUS PHARMACEUTICALS LLC-IT-2018VAL000559
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Female
|
Dehydration (Recovering / Resolving); Sopor (Recovering / Resolving); Hyponatraemia (Recovering / Resolving); Hyperkalaemia (Recovering / Resolving)
|
RAMIPRIL. (Suspect), Active: RAMIPRIL, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; FUROSEMIDE. (Suspect), Active: FUROSEMIDE, Dosage: 100 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['furosemide.', 'ramipril.']
|
['ramipril', 'furosemide']
|
['product used for unknown indication']
|
14,681,414
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-015452
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Extra dose administered (Recovered / Resolved)
|
SPIRIVA (Suspect), Active: TIOTROPIUM BROMIDE MONOHYDRATE, Dosage: FORM STRENGTH: 18 MCG; ? ADMINISTRATION CORRECT? NO ?ACTION(S) TAKEN WITH PRODUCT: DOSE NOT CHANGED, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed
|
['spiriva']
|
['tiotropium bromide monohydrate']
|
['chronic obstructive pulmonary disease']
|
14,681,929
| 2
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
US-ABBVIE-18P-163-2301570-00
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Hospitalisation (Fatal)
|
VENCLEXTA (Suspect), Active: VENETOCLAX, Dosage: STARTER PACK, Indication: MYELOID LEUKAEMIA, Action: Drug Withdrawn
|
['venclexta']
|
['venetoclax']
|
['myeloid leukaemia']
|
14,685,712
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
JP-BIOMARINAP-JP-2018-117605
|
Regulatory Authority
|
FDA-Public Use
| 44
|
Year
|
Male
|
Back pain (Recovered / Resolved)
|
ALDURAZYME (Suspect), Active: LARONIDASE, Dosage: 0.58 MG/KG, UNK, Indication: MUCOPOLYSACCHARIDOSIS I, Action: Dose not changed
|
['aldurazyme']
|
['laronidase']
|
['mucopolysaccharidosis i']
|
14,677,808
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-BIOGEN-2017BI00421116
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Female
|
Diarrhoea (Recovered / Resolved)
|
TECFIDERA (Suspect), Active: DIMETHYL FUMARATE, Indication: MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['tecfidera']
|
['dimethyl fumarate']
|
['multiple sclerosis']
|
14,678,433
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-CELGENEUS-USA-20180307555
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Male
|
Nausea (Recovered / Resolved); Tongue discomfort (Recovered / Resolved); Sleep disorder (Recovered / Resolved); Head discomfort (Recovered / Resolved); Feeling abnormal (Recovered / Resolved); Mood swings (Recovered / Resolved)
|
OTEZLA (Suspect), Active: APREMILAST, Dosage: 10 MILLIGRAM, Indication: PSORIASIS, Action: Drug Withdrawn, Additional: Yes; OTEZLA (Suspect), Active: APREMILAST, Dosage: 60 MILLIGRAM, Action: Drug Withdrawn, Additional: Yes
|
['otezla']
|
['apremilast']
|
['psoriasis']
|
14,679,905
| 2
|
Chile
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
CL-VIIV HEALTHCARE LIMITED-CL2018GSK049966
|
Regulatory Authority
|
FDA-Public Use
| 37
|
Year
| null |
Chronic inflammatory demyelinating polyradiculoneuropathy (Not Recovered / Not Resolved / Ongoing)
|
TRIUMEQ (Suspect), Active: ABACAVIR SULFATE\DOLUTEGRAVIR SODIUM\LAMIVUDINE, Dosage: UNK, Indication: HIV TEST POSITIVE, Action: Dose not changed
|
['triumeq']
|
['abacavir sulfate\\dolutegravir sodium\\lamivudine']
|
['hiv test positive']
|
14,680,663
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Life-threatening (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
US-GLENMARK PHARMACEUTICALS-2018GMK033605
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Lip swelling (Recovered / Resolved); Leukopenia (Recovered / Resolved); Febrile neutropenia (Recovered / Resolved); Alanine aminotransferase increased (Recovered / Resolved); Normocytic anaemia (Recovered / Resolved); Stomatitis (Recovered / Resolved); Aspartate aminotransferase increased (Recovered / Resolved); Periorbital oedema (Recovered / Resolved)
|
VERAPAMIL (Suspect), Active: VERAPAMIL HYDROCHLORIDE, Dosage: UNK, Indication: HYPERTENSION, Action: Drug Withdrawn, Additional: Yes
|
['verapamil']
|
['verapamil hydrochloride']
|
['hypertension']
|
14,684,640
| 2
|
France
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
FR-SA-2018SA087223
|
Regulatory Authority
|
FDA-Public Use
| 56
|
Year
|
Female
|
Eczema (Recovering / Resolving); Dermatitis bullous (Recovering / Resolving)
|
AUBAGIO (Suspect), Active: TERIFLUNOMIDE, Action: Unknown, Additional: Doesn't Apply
|
['aubagio']
|
['teriflunomide']
|
[]
|
14,676,839
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes)
| 20,180,324
| 20,180,711
|
US-JNJFOC-20180316101
|
Regulatory Authority
|
FDA-Public Use
| 88
|
Year
|
Male
|
Gastrointestinal haemorrhage (Recovering / Resolving)
|
ASPIRIN. (Suspect), Active: ASPIRIN, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: THROMBOSIS PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes
|
['aspirin.', 'xarelto']
|
['aspirin', 'rivaroxaban']
|
['thrombosis prophylaxis', 'atrial fibrillation', 'product used for unknown indication', 'cerebrovascular accident prophylaxis']
|
14,679,238
| 4
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
US-PFIZER INC-2018123547
|
Regulatory Authority
|
FDA-Public Use
| 85
|
Year
|
Male
|
Neck pain (Recovered / Resolved); Vision blurred (Recovered / Resolved); Blindness (Recovered / Resolved)
|
LYRICA (Suspect), Active: PREGABALIN, Dosage: 50 MG, FOUR TIMES A DAY, Indication: BACK PAIN, Action: Drug Withdrawn, Additional: Yes; LYRICA (Suspect), Active: PREGABALIN, Dosage: 50 MG, THREE TIMES A DAY, Indication: POST HERPETIC NEURALGIA, Action: Drug Withdrawn, Additional: Yes
|
['lyrica']
|
['pregabalin']
|
['back pain', 'post herpetic neuralgia']
|
14,679,247
| 2
|
Japan
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
PHJP2018JP006771
|
Regulatory Authority
|
FDA-Public Use
| 79
|
Year
|
Male
|
Asthenia (Recovered / Resolved); Epilepsy (Recovered / Resolved); Drug interaction (Recovered / Resolved)
|
TEGRETOL (Suspect), Active: CARBAMAZEPINE, Dosage: UNK, Indication: MENTAL DISORDER, Action: Unknown, Additional: Doesn't Apply
|
['tegretol']
|
['carbamazepine']
|
['mental disorder']
|
14,684,086
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-GLAXOSMITHKLINE-US2018GSK050618
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Live birth (Recovered / Resolved); Exposure during pregnancy (Recovered / Resolved)
|
BENLYSTA (Suspect), Active: BELIMUMAB, Dosage: UNK, Indication: SYSTEMIC LUPUS ERYTHEMATOSUS, Action: Drug Withdrawn, Additional: Yes
|
['benlysta']
|
['belimumab']
|
['systemic lupus erythematosus']
|
14,677,843
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
US-JNJFOC-20180319519
|
Regulatory Authority
|
FDA-Public Use
| 84
|
Year
|
Female
|
Diverticulum intestinal haemorrhagic (Recovered / Resolved)
|
XARELTO (Suspect), Active: RIVAROXABAN, Indication: THROMBOSIS PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: CEREBROVASCULAR ACCIDENT PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes
|
['xarelto']
|
['rivaroxaban']
|
['cerebrovascular accident prophylaxis', 'atrial fibrillation', 'thrombosis prophylaxis']
|
14,677,857
| 2
|
United Arab Emirates
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
AE-ABBVIE-18K-166-2300950-00
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Male
|
Dyspnoea (Not Recovered / Not Resolved / Ongoing); Pulmonary oedema (Not Recovered / Not Resolved / Ongoing); Hepatic enzyme increased (Not Recovered / Not Resolved / Ongoing); Cystitis (Not Recovered / Not Resolved / Ongoing)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Drug Withdrawn, Additional: No
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
14,677,858
| 3
|
United Kingdom of Great Britain and Northern Ireland
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
GB-ABBVIE-11P-167-0719871-00
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Female
|
Pneumonia (Fatal); Acute myeloid leukaemia (Fatal); Psoriatic arthropathy (Fatal); Agranulocytosis (Fatal); Neutropenic sepsis (Fatal)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable
|
['humira']
|
['adalimumab']
|
['rheumatoid arthritis']
|
14,681,489
| 2
|
Japan
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-025659
|
Regulatory Authority
|
FDA-Public Use
| 66
|
Year
|
Male
|
Pneumonitis (Recovering / Resolving)
|
PACLITAXEL. (Suspect), Active: PACLITAXEL, Dosage: 200 MG/M2, Q3WK, Indication: NON-SMALL CELL LUNG CANCER, Action: Drug Withdrawn, Additional: Yes; NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 360 MG, Q3WK, Indication: NON-SMALL CELL LUNG CANCER, Action: Drug Withdrawn, Additional: Yes; BEVACIZUMAB. (Suspect), Active: BEVACIZUMAB, Dosage: 15 MG/KG, Q3WK, Indication: NON-SMALL CELL LUNG CANCER, Action: Drug Withdrawn, Additional: Yes; CARBOPLATIN. (Suspect), Active: CARBOPLATIN, Dosage: 6 DF, Q3WK, Indication: NON-SMALL CELL LUNG CANCER, Action: Drug Withdrawn, Additional: Yes
|
['carboplatin.', 'nivolumab', 'paclitaxel.', 'bevacizumab.']
|
['carboplatin', 'nivolumab', 'bevacizumab', 'paclitaxel']
|
['non-small cell lung cancer']
|
14,681,533
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
US-REGENERON PHARMACEUTICALS, INC.-2018-10229
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Visual acuity reduced transiently (Recovered / Resolved); Eye pain (Recovered / Resolved); Vitreous floaters (Recovered / Resolved); Visual impairment (Recovered / Resolved)
|
EYLEA (Suspect), Active: AFLIBERCEPT, Dosage: 2 MG, MONTHLY, OU, Indication: NEOVASCULAR AGE-RELATED MACULAR DEGENERATION, Action: Dose not changed; EYLEA (Suspect), Active: AFLIBERCEPT, Dosage: 2 MG, MONTHLY, OU, LAST PRIOR EVENT, Action: Dose not changed
|
['eylea']
|
['aflibercept']
|
['neovascular age-related macular degeneration']
|
14,682,116
| 3
|
United States of America
|
Report from study
|
Yes
|
Death (Yes); Hospitalization (Yes); Life-threatening (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2018-026633
|
Regulatory Authority
|
FDA-Public Use
| 48
|
Year
|
Female
|
Acute respiratory failure (Not Recovered / Not Resolved / Ongoing); Sudden death (Fatal); Colitis (Fatal); Renal tubular necrosis (Not Recovered / Not Resolved / Ongoing); Lactic acidosis (Not Recovered / Not Resolved / Ongoing); Intestinal perforation (Not Recovered / Not Resolved / Ongoing); Pancreatitis (Not Recovered / Not Resolved / Ongoing); Septic shock (Fatal); Metabolic acidosis (Not Recovered / Not Resolved / Ongoing)
|
NIVOLUMAB (Suspect), Active: NIVOLUMAB, Dosage: 3 MG/KG, UNK, Indication: COLORECTAL CANCER, Action: Drug Withdrawn, Additional: No; IPILIMUMAB (Suspect), Active: IPILIMUMAB, Dosage: 1 MG/KG, UNK, Indication: COLORECTAL CANCER, Action: Drug Withdrawn, Additional: No; COBIMETINIB. (Suspect), Active: COBIMETINIB, Dosage: 60 MG, QD, Indication: COLORECTAL CANCER, Action: Drug Withdrawn, Additional: No
|
['nivolumab', 'ipilimumab', 'cobimetinib.']
|
['nivolumab', 'cobimetinib', 'ipilimumab']
|
['colorectal cancer']
|
14,682,812
| 2
|
China
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
CN-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-016335
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Oesophagitis (Recovered / Resolved)
|
SPIRIVA (Suspect), Active: TIOTROPIUM BROMIDE MONOHYDRATE, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Dose not changed
|
['spiriva']
|
['tiotropium bromide monohydrate']
|
['chronic obstructive pulmonary disease']
|
14,686,696
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,327
| 20,180,711
|
US-ARALEZ PHARMACEUTICALS R+D INC.-2018-ARA-000661
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Female
|
Dyspnoea (Recovered / Resolved); Therapeutic response unexpected (Recovered / Resolved); Abdominal discomfort (Recovered / Resolved); Dyspepsia (Recovered / Resolved)
|
BRILINTA (Suspect), Active: TICAGRELOR, Dosage: UNK UNK, BID, Indication: MYOCARDIAL INFARCTION, Action: Drug Withdrawn, Additional: Yes; OMEPRAZOLE. (Suspect), Active: OMEPRAZOLE, Dosage: 20 MG, QD, Indication: ABDOMINAL DISCOMFORT, Action: Unknown; METOPROLOL SUCCINATE. (Suspect), Active: METOPROLOL SUCCINATE, Dosage: 50 MG, BID, Indication: HEART RATE IRREGULAR, Action: Dose not changed; OMEPRAZOLE. (Suspect), Active: OMEPRAZOLE, Indication: DYSPEPSIA, Action: Unknown
|
['metoprolol succinate.', 'omeprazole.', 'brilinta']
|
['ticagrelor', 'omeprazole', 'metoprolol succinate']
|
['myocardial infarction', 'dyspepsia', 'heart rate irregular', 'abdominal discomfort']
|
14,677,894
| 2
|
Tunisia
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
TN-ABBVIE-18K-160-2295105-00
|
Regulatory Authority
|
FDA-Public Use
| 22
|
Year
|
Female
|
Anal fistula (Recovering / Resolving); C-reactive protein increased (Recovering / Resolving); Incision site swelling (Recovered / Resolved); Pain in extremity (Recovered / Resolved); Pain in extremity (Recovered / Resolved); Gait disturbance (Recovered / Resolved); Postoperative wound infection (Recovered / Resolved); Anal abscess (Recovering / Resolving)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: CROHN^S DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['humira']
|
['adalimumab']
|
['crohn^s disease']
|
14,678,638
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-016466
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Ischaemic stroke (Recovered / Resolved)
|
PRADAXA (Suspect), Active: DABIGATRAN ETEXILATE MESYLATE, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes
|
['pradaxa']
|
['dabigatran etexilate mesylate']
|
['atrial fibrillation']
|
14,679,342
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-PFIZER INC-2018122943
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Female
|
Musculoskeletal stiffness (Recovering / Resolving); Bone pain (Recovering / Resolving); Back pain (Recovering / Resolving)
|
IBRANCE (Suspect), Active: PALBOCICLIB, Dosage: 125 MG, CYCLIC [D 1-21 Q 28 DAYS], Indication: BREAST CANCER METASTATIC, Action: Unknown, Additional: Doesn't Apply
|
['ibrance']
|
['palbociclib']
|
['breast cancer metastatic']
|
14,681,594
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
JP-PFIZER INC-2018122695
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Male
|
Pleural effusion (Not Recovered / Not Resolved / Ongoing)
|
ESTRACYT (Suspect), Active: ESTRAMUSTINE PHOSPHATE SODIUM, Dosage: 313.4 MG/12 HOURS, Indication: PROSTATE CANCER, Action: Drug Withdrawn, Additional: No
|
['estracyt']
|
['estramustine phosphate sodium']
|
['prostate cancer']
|
14,684,140
| 2
|
India
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
PHHY2018IN048662
|
Regulatory Authority
|
FDA-Public Use
| 71
|
Year
|
Female
|
Thrombocytopenia (Recovered / Resolved); Renal failure (Recovered / Resolved); Mucosal inflammation (Recovering / Resolving); Oral candidiasis (Recovering / Resolving); Varicella (Recovered / Resolved); Febrile neutropenia (Recovered / Resolved); Epistaxis (Recovered / Resolved); Pneumonia (Recovered / Resolved); Epistaxis (Recovered / Resolved); Hepatic failure (Recovering / Resolving); Skin lesion (Recovering / Resolving)
|
LETROZOLE. (Suspect), Active: LETROZOLE, Dosage: 2.5 MG, QD, Indication: BREAST CANCER METASTATIC, Action: Dose not changed
|
['letrozole.']
|
['letrozole']
|
['breast cancer metastatic']
|
14,687,452
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,328
| 20,180,711
|
US-ROCHE-2091488
|
Regulatory Authority
|
FDA-Public Use
| 77
|
Year
|
Female
|
Dyspepsia (Recovered / Resolved); Respiratory paralysis (Recovered / Resolved); Vocal cord paralysis (Recovered / Resolved)
|
ESBRIET (Suspect), Active: PIRFENIDONE, Indication: IDIOPATHIC PULMONARY FIBROSIS, Action: Drug Withdrawn, Additional: Yes
|
['esbriet']
|
['pirfenidone']
|
['idiopathic pulmonary fibrosis']
|
14,687,484
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,328
| 20,180,711
|
US-AMGEN-USASL2018041544
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Rheumatoid arthritis (Not Recovered / Not Resolved / Ongoing)
|
ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Indication: RHEUMATOID ARTHRITIS, Action: Not applicable; ENBREL (Suspect), Active: ETANERCEPT, Dosage: 50 MG, QWK, Action: Not applicable
|
['enbrel']
|
['etanercept']
|
['rheumatoid arthritis']
|
14,687,494
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,328
| 20,180,711
|
US-BIOGEN-2018BI00524879
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Headache (Recovered / Resolved)
|
ZINBRYTA (Suspect), Active: DACLIZUMAB, Indication: MULTIPLE SCLEROSIS, Action: Unknown, Additional: Doesn't Apply
|
['zinbryta']
|
['daclizumab']
|
['multiple sclerosis']
|
14,684,162
| 2
|
France
|
Other
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
FR-MACLEODS PHARMACEUTICALS US LTD-MAC2018009505
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Blood bilirubin increased (Recovered / Resolved); Gamma-glutamyltransferase increased (Recovered / Resolved); Hepatocellular injury (Recovered / Resolved); Cholestasis (Recovered / Resolved); Transaminases increased (Recovered / Resolved); Blood alkaline phosphatase increased (Recovered / Resolved)
|
ACTISKENAN (Suspect), Active: MORPHINE SULFATE, Dosage: 60 MG, UNK,, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; COLCHICINE OPOCALCIUM (Suspect), Active: COLCHICINE, Dosage: 1 MG, UNK, Indication: BEHCET^S SYNDROME, Action: Drug Withdrawn, Additional: Yes; LOVENOX (Suspect), Active: ENOXAPARIN SODIUM, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; LEVOFLOXACIN. (Suspect), Active: LEVOFLOXACIN, Dosage: 1 DF, UNK,, Indication: ANTIBIOTIC PROPHYLAXIS, Action: Drug Withdrawn, Additional: Yes; PARACETAMOL (Suspect), Active: ACETAMINOPHEN, Dosage: 1 G, UNK, Action: Drug Withdrawn, Additional: Yes; ACTISKENAN (Suspect), Active: MORPHINE SULFATE, Dosage: 10 MG, UNK, CAPSULE, Action: Dose not changed; PARACETAMOL (Suspect), Active: ACETAMINOPHEN, Dosage: 4 G, UNK (INJECTION), Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; INEXIUM (Suspect), Active: ESOMEPRAZOLE, Dosage: 1 DF, UNK, (40 MG, GASTRO-RESISTANT TABLET), Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; LEVOCARNIL (Suspect), Active: LEVOCARNITINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; PYOSTACINE (Suspect), Active: PRISTINAMYCIN, Dosage: 3 G, UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes; ACTISKENAN (Suspect), Active: MORPHINE SULFATE, Dosage: 10 MG, UNK, Action: Dose not changed; ACUPAN (Suspect), Active: NEFOPAM HYDROCHLORIDE, Dosage: 80 MG, UNK, SOLUTION INJECTABLE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed; ACUPAN (Suspect), Active: NEFOPAM HYDROCHLORIDE, Dosage: 20 MG, UNK, Action: Dose not changed
|
['pyostacine', 'inexium', 'levocarnil', 'paracetamol', 'acupan', 'lovenox', 'levofloxacin.', 'actiskenan', 'colchicine opocalcium']
|
['nefopam hydrochloride', 'enoxaparin sodium', 'levocarnitine', 'acetaminophen', 'colchicine', 'esomeprazole', 'levofloxacin', 'pristinamycin', 'morphine sulfate']
|
['antibiotic prophylaxis', 'behcet^s syndrome', 'product used for unknown indication']
|
14,684,164
| 2
|
Bulgaria
|
Report from study
|
Yes
|
Life-threatening (Yes)
| 20,180,327
| 20,180,711
|
PHHO2018BG003846
|
Regulatory Authority
|
FDA-Public Use
| 72
|
Year
|
Female
|
Myocardial infarction (Recovered / Resolved with Sequelae)
|
PDR001 (Suspect), Active: INVESTIGATIONAL PRODUCT, Dosage: 400 MG, QW4, Indication: METASTATIC MALIGNANT MELANOMA, Action: Dose not changed; DABRAFENIB (Suspect), Active: DABRAFENIB, Dosage: 300 MG BID, Indication: METASTATIC MALIGNANT MELANOMA, Action: Not applicable; TRAMETINIB (Suspect), Active: TRAMETINIB, Dosage: 2 MG QD, Indication: METASTATIC MALIGNANT MELANOMA, Action: Not applicable
|
['trametinib', 'dabrafenib', 'pdr001']
|
['trametinib', 'dabrafenib', 'investigational product']
|
['metastatic malignant melanoma']
|
14,685,943
| 4
|
Thailand
|
Report from study
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
TH-GILEAD-2018-0329067
|
Regulatory Authority
|
FDA-Public Use
| 26
|
Year
|
Male
|
Hepatitis A (Not Recovered / Not Resolved / Ongoing)
|
FLUCONAZOLE. (Suspect), Active: FLUCONAZOLE, Dosage: 100 MG, QD, Indication: ALOPECIA, Action: Unknown, Additional: Doesn't Apply; BLINDED EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE (Suspect), Active: EMTRICITABINE\TENOFOVIR DISOPROXIL, Dosage: 2 DF, QD, Indication: PROPHYLAXIS AGAINST HIV INFECTION, Action: Drug Withdrawn, Additional: No; BLINDED PLACEBO (Suspect), Active: INVESTIGATIONAL PRODUCT, Dosage: 2 DF, QD, Indication: PROPHYLAXIS AGAINST HIV INFECTION, Action: Drug Withdrawn, Additional: No
|
['blinded placebo', 'fluconazole.', 'blinded emtricitabine/tenofovir disoproxil fumarate']
|
['emtricitabine\\tenofovir disoproxil', 'fluconazole', 'investigational product']
|
['alopecia', 'prophylaxis against hiv infection']
|
14,678,735
| 2
|
Poland
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
PL-AUROBINDO-AUR-APL-2018-015720
|
Regulatory Authority
|
FDA-Public Use
| 2
|
Year
|
Female
|
Pneumonitis (Recovering / Resolving); Pyrexia (Recovering / Resolving); Cough (Recovering / Resolving); Drug ineffective (Recovering / Resolving); Renal failure (Recovering / Resolving); Electrolyte imbalance (Recovering / Resolving); Auscultation (Recovering / Resolving); Dry mouth (Recovering / Resolving); Anaemia (Recovering / Resolving)
|
AZITHROMYCIN ANHYDROUS. (Suspect), Active: AZITHROMYCIN ANHYDROUS, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['azithromycin anhydrous.']
|
['azithromycin anhydrous']
|
['product used for unknown indication']
|
14,686,780
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-GILEAD-2018-0325229
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Male
|
Diarrhoea (Not Recovered / Not Resolved / Ongoing); Nausea (Not Recovered / Not Resolved / Ongoing); Blood test abnormal (Not Recovered / Not Resolved / Ongoing); Fatigue (Not Recovered / Not Resolved / Ongoing)
|
IDELALISIB (Suspect), Active: IDELALISIB, Dosage: 100 MG, BID, Indication: CHRONIC LYMPHOCYTIC LEUKAEMIA, Action: Dose not changed
|
['idelalisib']
|
['idelalisib']
|
['chronic lymphocytic leukaemia']
|
14,686,792
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,327
| 20,180,711
|
US-ACTELION-A-NJ2018-168878
|
Regulatory Authority
|
FDA-Public Use
| 24
|
Year
|
Male
|
Heart rate increased (Not Recovered / Not Resolved / Ongoing); Flushing (Not Recovered / Not Resolved / Ongoing); Nasopharyngitis (Not Recovered / Not Resolved / Ongoing); Unevaluable event (Not Recovered / Not Resolved / Ongoing); Blood pressure increased (Not Recovered / Not Resolved / Ongoing); Headache (Recovered / Resolved); Nausea (Not Recovered / Not Resolved / Ongoing)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 10 MG, QD, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Dose not changed; ADCIRCA (Suspect), Active: TADALAFIL, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; ORENITRAM (Suspect), Active: TREPROSTINIL, Dosage: 7.75 MG, TID, Action: Dose reduced, Additional: Yes; ORENITRAM (Suspect), Active: TREPROSTINIL, Dosage: UNK, Action: Dose reduced, Additional: Yes; UPTRAVI (Suspect), Active: SELEXIPAG, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; ORENITRAM (Suspect), Active: TREPROSTINIL, Dosage: 7.5 MG, TID, Indication: PULMONARY HYPERTENSION, Action: Dose reduced, Additional: Yes
|
['adcirca', 'uptravi', 'orenitram', 'ambrisentan']
|
['ambrisentan', 'selexipag', 'tadalafil', 'treprostinil']
|
['pulmonary arterial hypertension', 'product used for unknown indication', 'pulmonary hypertension']
|
14,678,801
| 3
|
Germany
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
DE-UCBSA-2018005454
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Bronchitis (Recovered / Resolved); Pleurisy (Recovered / Resolved)
|
CERTOLIZUMAB PEGOL AUTOCLICKS (Suspect), Active: CERTOLIZUMAB PEGOL, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn, Additional: Yes; CERTOLIZUMAB PEGOL AUTOCLICKS (Suspect), Active: CERTOLIZUMAB PEGOL, Dosage: 200 MG, EV 2 WEEKS(QOW), Indication: AXIAL SPONDYLOARTHRITIS, Action: Drug Withdrawn, Additional: Yes
|
['certolizumab pegol autoclicks']
|
['certolizumab pegol']
|
['psoriatic arthropathy', 'axial spondyloarthritis']
|
14,680,928
| 2
|
Netherlands
|
Spontaneous
|
Yes
|
Life-threatening (Yes)
| 20,180,326
| 20,180,711
|
PHHY2018NL052458
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Ventricular tachycardia (Not Recovered / Not Resolved / Ongoing); Palpitations (Not Recovered / Not Resolved / Ongoing)
|
ENTRESTO (Suspect), Active: SACUBITRIL\VALSARTAN, Dosage: 50 MG (24/26 MG), BID, Indication: CARDIAC FAILURE, Action: Drug Withdrawn, Additional: No
|
['entresto']
|
['sacubitril\\valsartan']
|
['cardiac failure']
|
14,681,644
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
US-009507513-1803USA008894
|
Regulatory Authority
|
FDA-Public Use
| 43
|
Year
|
Female
|
Device difficult to use (Recovered / Resolved); Complication of device removal (Recovered / Resolved); Complication associated with device (Recovered / Resolved); Device breakage (Recovered / Resolved)
|
NEXPLANON (Suspect), Active: ETONOGESTREL, Dosage: ONE ROD EVERY THREE YEARS, Indication: CONTRACEPTION, Action: Drug Withdrawn, Additional: Yes
|
['nexplanon']
|
['etonogestrel']
|
['contraception']
|
14,682,275
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-SUNOVION-2018SUN000968
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Dyspnoea (Recovering / Resolving)
|
LONHALA MAGNAIR (Suspect), Active: GLYCOPYRROLATE, Dosage: 25 MCG/ML TWICE DAILY NEBULIZING SOLUTION, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['lonhala magnair']
|
['glycopyrrolate']
|
['chronic obstructive pulmonary disease']
|
14,683,005
| 2
|
Japan
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
JP-ROCHE-2094226
|
Regulatory Authority
|
FDA-Public Use
| 14
|
Year
|
Female
|
Post transplant lymphoproliferative disorder (Recovered / Resolved); Osteomyelitis bacterial (Recovered / Resolved)
|
TACROLIMUS HYDRATE (Suspect), Active: TACROLIMUS, Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Unknown, Additional: Doesn't Apply; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Dosage: DOSAGE IS UNCERTAIN., Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Unknown, Additional: Doesn't Apply; CYTARABINE. (Suspect), Active: CYTARABINE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; CELLCEPT (Suspect), Active: MYCOPHENOLATE MOFETIL\MYCOPHENOLATE MOFETIL HYDROCHLORIDE, Indication: PROPHYLAXIS AGAINST TRANSPLANT REJECTION, Action: Unknown, Additional: Doesn't Apply; PIRARUBICIN (Suspect), Active: PIRARUBICIN, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; HYDROCORTISONE. (Suspect), Active: HYDROCORTISONE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; VINCRISTINE (Suspect), Active: VINCRISTINE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; PREDNISOLONE. (Suspect), Active: PREDNISOLONE, Action: Unknown, Additional: Doesn't Apply; RITUXIMAB. (Suspect), Active: RITUXIMAB, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Indication: POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, Action: Unknown, Additional: Doesn't Apply
|
['cyclophosphamide.', 'vincristine', 'methotrexate.', 'dexamethasone.', 'pirarubicin', 'cellcept', 'rituximab.', 'prednisolone.', 'cytarabine.', 'hydrocortisone.', 'tacrolimus hydrate']
|
['mycophenolate mofetil\\mycophenolate mofetil hydrochloride', 'vincristine', 'hydrocortisone', 'rituximab', 'cyclophosphamide', 'tacrolimus', 'methotrexate', 'pirarubicin', 'dexamethasone', 'prednisolone', 'cytarabine']
|
['prophylaxis against transplant rejection', 'post transplant lymphoproliferative disorder']
|
14,683,686
| 2
|
Italy
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
IT-THROMBOGENICS-SPO-2018-2518
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Female
|
Optical coherence tomography abnormal (Recovered / Resolved)
|
JETREA (Suspect), Active: OCRIPLASMIN, Dosage: 0.125 MG, ONE TIME DOSE, Indication: VITREOMACULAR INTERFACE ABNORMAL, Action: Not applicable
|
['jetrea']
|
['ocriplasmin']
|
['vitreomacular interface abnormal']
|
14,683,694
| 2
|
Italy
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
PHHY2018IT053790
|
Regulatory Authority
|
FDA-Public Use
| 61
|
Year
|
Male
|
Hepatitis acute (Recovering / Resolving)
|
COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: 150 MG, UNK, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn, Additional: Yes; ISONIAZID. (Suspect), Active: ISONIAZID, Dosage: 300 MG, QD, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: Yes
|
['isoniazid.', 'cosentyx']
|
['secukinumab', 'isoniazid']
|
['psoriatic arthropathy', 'product used for unknown indication']
|
14,684,277
| 2
|
Turkey
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
PHHY2018TR052489
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Female
|
Condition aggravated (Not Recovered / Not Resolved / Ongoing); Pneumonia (Recovering / Resolving); Musculoskeletal stiffness (Not Recovered / Not Resolved / Ongoing)
|
STALEVO (Suspect), Active: CARBIDOPA\ENTACAPONE\LEVODOPA, Dosage: 50 MG, QID, Indication: PARKINSON^S DISEASE, Action: Dose not changed; COMTAN (Suspect), Active: ENTACAPONE, Dosage: 100 MG (HALF TABLET COUPLE OF YEARS), Indication: PARKINSON^S DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['stalevo', 'comtan']
|
['carbidopa\\entacapone\\levodopa', 'entacapone']
|
['parkinson^s disease']
|
14,684,288
| 2
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,327
| 20,180,711
|
PHHY2018FR053565
|
Regulatory Authority
|
FDA-Public Use
| 59
|
Year
|
Male
|
Pulmonary embolism (Recovered / Resolved with Sequelae)
|
SANDOSTATIN LAR DEPOT (Suspect), Active: OCTREOTIDE ACETATE, Dosage: 30 MG, QMO, Indication: NEUROENDOCRINE TUMOUR, Action: Drug Withdrawn, Additional: Yes
|
['sandostatin lar depot']
|
['octreotide acetate']
|
['neuroendocrine tumour']
|
14,685,361
| 2
|
Spain
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
ES-GILEAD-2018-0328534
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Male
|
Ill-defined disorder (Not Recovered / Not Resolved / Ongoing); Chronic kidney disease (Not Recovered / Not Resolved / Ongoing)
|
GENVOYA (Suspect), Active: COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE FUMARATE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['genvoya']
|
['cobicistat\\elvitegravir\\emtricitabine\\tenofovir alafenamide fumarate']
|
['product used for unknown indication']
|
14,687,604
| 2
|
Czechia
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,328
| 20,180,711
|
CZ-AMGEN-CZESP2018039371
|
Regulatory Authority
|
FDA-Public Use
| 54
|
Year
|
Female
|
Thoracic vertebral fracture (Recovering / Resolving)
|
PROLIA (Suspect), Active: DENOSUMAB, Dosage: 60 MG, Q6MO, Indication: OSTEOPOROTIC FRACTURE, Action: Not applicable
|
['prolia']
|
['denosumab']
|
['osteoporotic fracture']
|
14,687,652
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,328
| 20,180,711
|
US-APOTEX-2018AP008644
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Female
|
Condition aggravated (Recovering / Resolving); Catatonia (Recovering / Resolving)
|
DOXORUBICIN (Suspect), Active: DOXORUBICIN, Indication: CHEMOTHERAPY, Action: Drug Withdrawn, Additional: Yes; DOXORUBICIN (Suspect), Active: DOXORUBICIN, Indication: INVASIVE DUCTAL BREAST CARCINOMA, Action: Drug Withdrawn, Additional: Yes; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: INVASIVE DUCTAL BREAST CARCINOMA, Action: Drug Withdrawn, Additional: Yes; HALOPERIDOL. (Suspect), Active: HALOPERIDOL, Indication: DELIRIUM, Action: Unknown, Additional: Doesn't Apply; DEXAMETHASONE. (Suspect), Active: DEXAMETHASONE, Indication: CHEMOTHERAPY, Action: Drug Withdrawn, Additional: Yes; OLANZAPINE. (Suspect), Active: OLANZAPINE, Indication: DELIRIUM, Action: Unknown, Additional: Doesn't Apply
|
['haloperidol.', 'dexamethasone.', 'doxorubicin', 'olanzapine.']
|
['haloperidol', 'olanzapine', 'doxorubicin', 'dexamethasone']
|
['delirium', 'chemotherapy', 'invasive ductal breast carcinoma']
|
14,677,065
| 2
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,324
| 20,180,711
|
US-TESARO, INC-US-2018TSO00782
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Memory impairment (Not Recovered / Not Resolved / Ongoing); Feeling abnormal (Not Recovered / Not Resolved / Ongoing); Drug intolerance (Not Recovered / Not Resolved / Ongoing); Disorientation (Recovered / Resolved); Renal disorder (Not Recovered / Not Resolved / Ongoing)
|
ZEJULA (Suspect), Active: NIRAPARIB, Dosage: 100 MG, QD, Action: Drug Withdrawn, Additional: Yes; ZEJULA (Suspect), Active: NIRAPARIB, Dosage: 300 MG, QD, Indication: OVARIAN CANCER, Action: Drug Withdrawn, Additional: Yes
|
['zejula']
|
['niraparib']
|
['ovarian cancer']
|
14,681,667
| 2
|
Turkey
|
Report from study
|
Yes
|
Congenital anomaly (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
TR-MYLANLABS-2018M1020858
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Foetal exposure during pregnancy (Recovered / Resolved)
|
METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Not applicable
|
['metformin']
|
['metformin hydrochloride']
|
['product used for unknown indication']
|
14,682,290
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
US-SUNOVION-2018SUN001028
|
Regulatory Authority
|
FDA-Public Use
| 60
|
Year
|
Female
|
Tachycardia (Recovered / Resolved); Oxygen saturation decreased (Recovered / Resolved); Asthenia (Recovered / Resolved); Dyspnoea (Recovered / Resolved)
|
LONHALA MAGNAIR (Suspect), Active: GLYCOPYRROLATE, Indication: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, Action: Drug Withdrawn, Additional: Yes
|
['lonhala magnair']
|
['glycopyrrolate']
|
['chronic obstructive pulmonary disease']
|
14,687,679
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,328
| 20,180,711
|
US-CELGENEUS-USA-20180308771
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Headache (Recovered / Resolved); Injection site pruritus (Recovered / Resolved)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Dosage: 40 MILLIGRAM, Indication: PSORIATIC ARTHROPATHY, Action: Dose not changed; OTEZLA (Suspect), Active: APREMILAST, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['otezla', 'humira']
|
['apremilast', 'adalimumab']
|
['psoriatic arthropathy', 'product used for unknown indication']
|
14,678,134
| 2
|
Taiwan (Province of China)
|
Report from study
|
Yes
|
Death (Yes)
| 20,180,326
| 20,180,711
|
TW-ABBVIE-18K-153-2300047-00
|
Regulatory Authority
|
FDA-Public Use
| 44
|
Year
|
Male
|
Death (Fatal)
|
HUMIRA (Suspect), Active: ADALIMUMAB, Indication: HIDRADENITIS, Action: Not applicable
|
['humira']
|
['adalimumab']
|
['hidradenitis']
|
14,679,577
| 2
|
Netherlands
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
NL-ABBVIE-18S-114-2299834-00
|
Regulatory Authority
|
FDA-Public Use
| 42
|
Year
|
Female
|
Breast cancer metastatic (Not Recovered / Not Resolved / Ongoing)
|
LUCRIN (Suspect), Active: LEUPROLIDE ACETATE, Indication: BREAST CANCER, Action: Dose not changed; LUCRIN (Suspect), Active: LEUPROLIDE ACETATE, Indication: BREAST CANCER, Action: Dose Increased
|
['lucrin']
|
['leuprolide acetate']
|
['breast cancer']
|
14,680,212
| 2
|
Italy
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
PHHY2015IT177658
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Female
|
Vasculitis (Recovered / Resolved)
|
ETANERCEPT (Suspect), Active: ETANERCEPT, Indication: PSORIASIS, Action: Unknown, Additional: Doesn't Apply; ETANERCEPT (Suspect), Active: ETANERCEPT, Indication: RHEUMATOID ARTHRITIS, Action: Unknown, Additional: Doesn't Apply
|
['etanercept']
|
['etanercept']
|
['rheumatoid arthritis', 'psoriasis']
|
14,681,686
| 2
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
GB-PFIZER INC-2018115691
|
Regulatory Authority
|
FDA-Public Use
| 11
|
Year
|
Male
|
Induration (Recovered / Resolved); Administration site extravasation (Recovered / Resolved); Pallor (Recovered / Resolved); Erythema (Recovered / Resolved); Peripheral swelling (Recovered / Resolved)
|
DOPAMINE HCL (Suspect), Active: DOPAMINE HYDROCHLORIDE, Dosage: 80MG UNIT DOSE IN 5% DEXTROSE SOLUTION, Action: Drug Withdrawn, Additional: Yes
|
['dopamine hcl']
|
['dopamine hydrochloride']
|
[]
|
14,682,383
| 2
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,326
| 20,180,711
|
US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2018-BI-016582
|
Regulatory Authority
|
FDA-Public Use
| 76
|
Year
|
Male
|
Back injury (Not Recovered / Not Resolved / Ongoing)
|
COMBIVENT (Suspect), Active: ALBUTEROL SULFATE\IPRATROPIUM BROMIDE, Dosage: STRENGTH: 20MCG/100 MCG; ADMINISTRATION CORRECT? NR(NOT REPORTED); ACTION TAKEN: DOSE NOT CHANGED, Indication: ASTHMA, Action: Dose not changed; OXYCODONE (Suspect), Active: OXYCODONE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['oxycodone', 'combivent']
|
['oxycodone', 'albuterol sulfate\\ipratropium bromide']
|
['asthma', 'product used for unknown indication']
|
14,683,079
| 2
|
Japan
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
JP-ROCHE-2097519
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Anaphylactoid reaction (Recovered / Resolved)
|
OMALIZUMAB. (Suspect), Active: OMALIZUMAB, Dosage: 75 MG TO 600 MG SUBCUTANEOUSLY EVERY 2 OR 4 WEEKS, Indication: ASTHMA, Action: Unknown, Additional: Doesn't Apply
|
['omalizumab.']
|
['omalizumab']
|
['asthma']
|
14,683,083
| 2
|
United States of America
|
Report from study
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,327
| 20,180,711
|
US-GILEAD-2018-0329044
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Female
|
Dyspnoea (Not Recovered / Not Resolved / Ongoing); Intentional dose omission (Recovered / Resolved)
|
AMBRISENTAN (Suspect), Active: AMBRISENTAN, Dosage: 10 MG, QD, Indication: PULMONARY ARTERIAL HYPERTENSION, Action: Dose not changed
|
['ambrisentan']
|
['ambrisentan']
|
['pulmonary arterial hypertension']
|
14,684,337
| 3
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
US-PFIZER INC-2017480462
|
Regulatory Authority
|
FDA-Public Use
| 67
|
Year
|
Female
|
Dyspnoea exertional (Not Recovered / Not Resolved / Ongoing); Diarrhoea (Recovered / Resolved); Leukopenia (Not Recovered / Not Resolved / Ongoing); Dizziness (Not Recovered / Not Resolved / Ongoing); Bone marrow failure (Recovered / Resolved); Abdominal discomfort (Recovering / Resolving); Fatigue (Not Recovered / Not Resolved / Ongoing)
|
IBRANCE (Suspect), Active: PALBOCICLIB, Dosage: 125 MG, DAILY, Indication: BREAST CANCER FEMALE, Action: Drug Withdrawn, Additional: Yes; IBRANCE (Suspect), Active: PALBOCICLIB, Dosage: 100 MG, DAILY, Action: Drug Withdrawn, Additional: Yes; IBRANCE (Suspect), Active: PALBOCICLIB, Dosage: 125 MG, DAILY, Action: Drug Withdrawn, Additional: Yes
|
['ibrance']
|
['palbociclib']
|
['breast cancer female']
|
14,684,898
| 3
|
Japan
|
Spontaneous
|
No
| null | 20,180,327
| 20,180,711
|
JP-009507513-1803JPN002172J
|
Regulatory Authority
|
FDA-Public Use
| 82
|
Year
|
Female
|
Platelet count decreased (Recovered / Resolved)
|
KEYTRUDA (Suspect), Active: PEMBROLIZUMAB, Dosage: 200 MG, UNK, Indication: LUNG NEOPLASM MALIGNANT, Action: Dose not changed
|
['keytruda']
|
['pembrolizumab']
|
['lung neoplasm malignant']
|
14,678,949
| 2
|
Canada
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
PHHY2018CA007263
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Palpitations (Recovered / Resolved)
|
COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: 300 MG, QMO, Action: Drug Withdrawn, Additional: Yes; COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: 150 MG, QW, Indication: PSORIATIC ARTHROPATHY, Action: Drug Withdrawn, Additional: Yes; COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: 150 MG, QW, Action: Drug Withdrawn, Additional: Yes; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['methotrexate.', 'cosentyx']
|
['secukinumab', 'methotrexate']
|
['psoriatic arthropathy', 'product used for unknown indication']
|
14,679,613
| 3
|
United States of America
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,326
| 20,180,711
|
US-ALLERGAN-1812674US
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Male
|
Bowel movement irregularity (Not Recovered / Not Resolved / Ongoing); Muscular weakness (Not Recovered / Not Resolved / Ongoing); Skin lesion (Not Recovered / Not Resolved / Ongoing); Abdominal distension (Recovering / Resolving); Dyspepsia (Not Recovered / Not Resolved / Ongoing); Diabetes mellitus (Not Recovered / Not Resolved / Ongoing); Flatulence (Recovering / Resolving)
|
LINZESS (Suspect), Active: LINACLOTIDE, Dosage: 145 ?G, QAM, Indication: CONSTIPATION, Action: Drug Withdrawn, Additional: Yes; LINZESS (Suspect), Active: LINACLOTIDE, Indication: ABDOMINAL PAIN UPPER, Action: Drug Withdrawn, Additional: Yes
|
['linzess']
|
['linaclotide']
|
['abdominal pain upper', 'constipation']
|
14,680,238
| 2
|
United States of America
|
Spontaneous
|
No
| null | 20,180,326
| 20,180,711
|
US-CELGENEUS-USA-20180307235
|
Regulatory Authority
|
FDA-Public Use
| 81
|
Year
|
Female
|
Peripheral swelling (Not Recovered / Not Resolved / Ongoing)
|
REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 15 MILLIGRAM, Indication: PLASMA CELL MYELOMA, Action: Unknown, Additional: Doesn't Apply; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 5 MILLIGRAM, Action: Unknown, Additional: Doesn't Apply; REVLIMID (Suspect), Active: LENALIDOMIDE, Dosage: 2.5 MILLIGRAM, Action: Unknown, Additional: Doesn't Apply
|
['revlimid']
|
['lenalidomide']
|
['plasma cell myeloma']
|
14,681,187
| 2
|
Germany
|
Spontaneous
|
Yes
|
Death (Yes); Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
DE-AMGEN-DEUSP2018040705
|
Regulatory Authority
|
FDA-Public Use
| 78
|
Year
|
Male
|
Respiratory distress (Recovered / Resolved); Emotional distress (Recovered / Resolved); Dyspnoea (Recovered / Resolved); Cardiac failure congestive (Fatal)
|
RITUXIMAB. (Suspect), Active: RITUXIMAB, Dosage: 686 MG, QD (1 TIMES A DAY FOR 1 DAY), Indication: B-CELL LYMPHOMA, Action: Unknown; VINCRISTINE (Suspect), Active: VINCRISTINE, Dosage: 2 MG, QD, Indication: B-CELL LYMPHOMA, Action: Unknown; PREDNISOLON (Suspect), Active: PREDNISOLONE, Dosage: 100 MG, QD (FOR 5 DAY), Indication: B-CELL LYMPHOMA, Action: Unknown; RITUXIMAB. (Suspect), Active: RITUXIMAB, Dosage: 686 MG, QD, MOST RECENT CYCLE NUMBER 6. LAST DOSE PRIOR TO ONSET OF EVENT (1 TIMES A DAY FOR 1 DAY), Action: Unknown; DOXORUBICIN (Suspect), Active: DOXORUBICIN, Dosage: 90 MG, QD, Indication: B-CELL LYMPHOMA, Action: Unknown; VINCRISTINE (Suspect), Active: VINCRISTINE, Dosage: 2 MG, QD, Action: Unknown; DOXORUBICIN (Suspect), Active: DOXORUBICIN, Dosage: 91 MG, QD, Action: Unknown; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: 1365 MG, QD, Action: Unknown; PEGFILGRASTIM (Suspect), Active: PEGFILGRASTIM, Dosage: 6 MG, QD, Indication: B-CELL LYMPHOMA, Action: Not applicable; CYCLOPHOSPHAMIDE. (Suspect), Active: CYCLOPHOSPHAMIDE, Dosage: 1350 MG, QD, Indication: B-CELL LYMPHOMA, Action: Unknown; PREDNISOLON (Suspect), Active: PREDNISOLONE, Dosage: 100 MG, QD (1 TIMES A DAY FOR 5 DAY), Action: Unknown
|
['cyclophosphamide.', 'vincristine', 'doxorubicin', 'prednisolon', 'rituximab.', 'pegfilgrastim']
|
['vincristine', 'doxorubicin', 'rituximab', 'cyclophosphamide', 'prednisolone', 'pegfilgrastim']
|
['b-cell lymphoma']
|
14,686,195
| 3
|
United States of America
|
Report from study
|
No
| null | 20,180,327
| 20,180,711
|
PHEH2018US011638
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Psoriasis (Not Recovered / Not Resolved / Ongoing)
|
COSENTYX (Suspect), Active: SECUKINUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['cosentyx']
|
['secukinumab']
|
['product used for unknown indication']
|
14,686,252
| 2
|
Belgium
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,327
| 20,180,711
|
BE-PFIZER INC-2018118863
|
Regulatory Authority
|
FDA-Public Use
| 55
|
Year
|
Male
|
Renal cell carcinoma (Not Recovered / Not Resolved / Ongoing)
|
METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Unknown, Additional: Doesn't Apply; INFLIXIMAB HOSPIRA (Suspect), Active: INFLIXIMAB, Dosage: FOR 30 MONTHS /ANTI-TNF TREATMENT, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply; AZATHIOPRINE. (Suspect), Active: AZATHIOPRINE, Indication: IMMUNOSUPPRESSANT DRUG THERAPY, Action: Unknown, Additional: Doesn't Apply; AZATHIOPRINE. (Suspect), Active: AZATHIOPRINE, Dosage: UNK, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply; ADALIMUMAB (Suspect), Active: ADALIMUMAB, Dosage: FOR 2 MONTHS/ANTI-TNF TREATMENT, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE SODIUM. (Suspect), Active: METHOTREXATE SODIUM, Indication: CROHN^S DISEASE, Action: Unknown, Additional: Doesn't Apply
|
['azathioprine.', 'infliximab hospira', 'adalimumab', 'methotrexate sodium.']
|
['infliximab', 'azathioprine', 'methotrexate sodium', 'adalimumab']
|
['crohn^s disease', 'immunosuppressant drug therapy']
|
14,678,969
| 2
|
Ireland
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,326
| 20,180,711
|
PHHY2018IE050762
|
Regulatory Authority
|
FDA-Public Use
| 82
|
Year
|
Male
|
Acute kidney injury (Not Recovered / Not Resolved / Ongoing)
|
BENDROFLUMETHIAZIDE (Suspect), Active: BENDROFLUMETHIAZIDE, Dosage: 2.5 MG, QD, Indication: HYPERTENSION, Action: Unknown, Additional: Doesn't Apply; ARCOXIA (Suspect), Active: ETORICOXIB, Dosage: 120 MG, UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply; METFORMIN (Suspect), Active: METFORMIN HYDROCHLORIDE, Dosage: 850 MG, Q12H, Indication: DIABETES MELLITUS, Action: Unknown, Additional: Doesn't Apply
|
['arcoxia', 'metformin', 'bendroflumethiazide']
|
['etoricoxib', 'metformin hydrochloride', 'bendroflumethiazide']
|
['diabetes mellitus', 'hypertension', 'product used for unknown indication']
|
14,795,804
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018031446
|
Regulatory Authority
|
FDA-Public Use
| 70
|
Year
|
Male
|
Blood triglycerides increased (Not Recovered / Not Resolved / Ongoing); Blood pressure increased (Recovered / Resolved)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: LOW DENSITY LIPOPROTEIN INCREASED, Action: Unknown, Additional: Doesn't Apply; REPATHA (Suspect), Active: EVOLOCUMAB, Indication: BLOOD CHOLESTEROL ABNORMAL, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['blood cholesterol abnormal', 'low density lipoprotein increased']
|
14,796,355
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018005265
|
Regulatory Authority
|
FDA-Public Use
| 73
|
Year
|
Male
|
Abdominal pain upper (Recovered / Resolved); Headache (Recovered / Resolved)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: TYPE V HYPERLIPIDAEMIA, Action: Unknown, Additional: Doesn't Apply; REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['hypercholesterolaemia', 'type v hyperlipidaemia']
|
14,793,771
| 1
|
Estonia
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,423
| 20,180,711
|
EE-ROCHE-2111170
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Cyanosis (Fatal); Contraindicated product administered (Fatal); Anxiety (Fatal); Death (Fatal); Off label use (Fatal)
|
DIAZEPAM. (Suspect), Active: DIAZEPAM, Indication: OFF LABEL USE, Action: Not applicable; HALOPERIDOL. (Suspect), Active: HALOPERIDOL, Indication: OFF LABEL USE, Action: Not applicable; DIAZEPAM. (Suspect), Active: DIAZEPAM, Indication: CONFUSIONAL STATE, Action: Not applicable; HALOPERIDOL. (Suspect), Active: HALOPERIDOL, Indication: CONFUSIONAL STATE, Action: Not applicable
|
['haloperidol.', 'diazepam.']
|
['diazepam', 'haloperidol']
|
['confusional state', 'off label use']
|
14,794,184
| 1
|
United Kingdom of Great Britain and Northern Ireland
|
Spontaneous
|
Yes
|
Other (Yes)
| 20,180,423
| 20,180,711
|
GB-GILEAD-2018-0334377
|
Regulatory Authority
|
FDA-Public Use
| 64
|
Year
|
Male
|
Drug interaction (Recovered / Resolved); Vomiting (Recovered / Resolved)
|
RANOLAZINE. (Suspect), Active: RANOLAZINE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Dose not changed
|
['ranolazine.']
|
['ranolazine']
|
['product used for unknown indication']
|
14,794,546
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,180,423
| 20,180,711
|
US-CELGENEUS-USA-20180407079
|
Regulatory Authority
|
FDA-Public Use
| 51
|
Year
|
Female
|
Gastrooesophageal reflux disease (Not Recovered / Not Resolved / Ongoing)
|
OTEZLA (Suspect), Active: APREMILAST, Dosage: 60 MILLIGRAM, Indication: PSORIATIC ARTHROPATHY, Action: Unknown, Additional: Doesn't Apply
|
['otezla']
|
['apremilast']
|
['psoriatic arthropathy']
|
14,794,886
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-THERATECHNOLOGIES, INC.-TH-2018-00239
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Injection site pain (Not Recovered / Not Resolved / Ongoing)
|
EGRIFTA (Suspect), Active: TESAMORELIN, Dosage: UNK, Action: Dose not changed
|
['egrifta']
|
['tesamorelin']
|
[]
|
14,795,446
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,423
| 20,180,711
|
US-ENDO PHARMACEUTICALS INC-2018-035639
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Death (Fatal)
|
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
|
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
|
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'hydromorphone', 'aspirin\\oxycodone hydrochloride', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
|
['pain']
|
14,795,551
| 1
|
Greece
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,423
| 20,180,711
|
GR-TAKEDA-2018TEU002672
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Pancreatitis (Fatal)
|
VIPIDIA (Suspect), Active: ALOGLIPTIN BENZOATE, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown, Additional: Doesn't Apply
|
['vipidia']
|
['alogliptin benzoate']
|
['product used for unknown indication']
|
14,795,821
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018043773
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Eye pruritus (Recovering / Resolving)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 420 MG, QMO, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['hypercholesterolaemia']
|
14,796,094
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018008240
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Male
|
Rash macular (Not Recovered / Not Resolved / Ongoing)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: HYPERCHOLESTEROLAEMIA, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['hypercholesterolaemia']
|
14,796,376
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2017192476
|
Regulatory Authority
|
FDA-Public Use
| 74
|
Year
|
Male
|
Fibromyalgia (Not Recovered / Not Resolved / Ongoing); Rash (Not Recovered / Not Resolved / Ongoing)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: HYPERLIPIDAEMIA, Action: Drug Withdrawn, Additional: No
|
['repatha']
|
['evolocumab']
|
['hyperlipidaemia']
|
14,793,777
| 1
|
Spain
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,423
| 20,180,711
|
ES-JNJFOC-20180426941
|
Regulatory Authority
|
FDA-Public Use
| 57
|
Year
|
Female
|
Cytomegalovirus infection (Not Recovered / Not Resolved / Ongoing)
|
SIMPONI (Suspect), Active: GOLIMUMAB, Indication: PROCTITIS, Action: Unknown, Additional: Doesn't Apply; SIMPONI (Suspect), Active: GOLIMUMAB, Indication: COLITIS ULCERATIVE, Action: Unknown, Additional: Doesn't Apply
|
['simponi']
|
['golimumab']
|
['proctitis', 'colitis ulcerative']
|
14,794,193
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,423
| 20,180,711
|
PHHY2018US064550
|
Regulatory Authority
|
FDA-Public Use
| 15
|
Year
|
Male
|
Facial paralysis (Recovering / Resolving); Hemiparesis (Recovering / Resolving); Pallor (Recovering / Resolving); Anxiety (Recovering / Resolving); Neurotoxicity (Recovering / Resolving); Dysarthria (Recovering / Resolving)
|
METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: 5 G/M2, Indication: ACUTE LYMPHOCYTIC LEUKAEMIA, Action: Unknown, Additional: Doesn't Apply; METHOTREXATE. (Suspect), Active: METHOTREXATE, Dosage: UNK, Action: Unknown, Additional: Doesn't Apply
|
['methotrexate.']
|
['methotrexate']
|
['acute lymphocytic leukaemia']
|
14,794,555
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes); Other (Yes)
| 20,180,423
| 20,180,711
|
US-ASTRAZENECA-2018SE48597
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Death (Fatal)
|
NEXIUM (Suspect), Active: ESOMEPRAZOLE MAGNESIUM, Action: Unknown, Additional: Doesn't Apply; NEXIUM 24HR (Suspect), Active: ESOMEPRAZOLE MAGNESIUM, Action: Unknown, Additional: Doesn't Apply; PRILOSEC OTC (Suspect), Active: OMEPRAZOLE MAGNESIUM, Action: Unknown, Additional: Doesn't Apply; PREVACID (Suspect), Active: LANSOPRAZOLE, Action: Unknown, Additional: Doesn't Apply; PROTONIX (Suspect), Active: PANTOPRAZOLE SODIUM, Action: Unknown, Additional: Doesn't Apply; DEXILANT (Suspect), Active: DEXLANSOPRAZOLE, Action: Unknown, Additional: Doesn't Apply; PRILOSEC (Suspect), Active: OMEPRAZOLE MAGNESIUM, Action: Unknown, Additional: Doesn't Apply
|
['protonix', 'prilosec otc', 'nexium 24hr', 'prilosec', 'nexium', 'dexilant', 'prevacid']
|
['lansoprazole', 'esomeprazole magnesium', 'omeprazole magnesium', 'dexlansoprazole', 'pantoprazole sodium']
|
[]
|
14,794,901
| 1
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes); Other (Yes)
| 20,180,423
| 20,180,711
|
FR-SHIRE-FR201814454
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Pulmonary arterial hypertension (Not Recovered / Not Resolved / Ongoing)
|
XAGRID (Suspect), Active: ANAGRELIDE HYDROCHLORIDE, Dosage: 0.5 MG X3 LE MATIN ET X4 LE SOIR, Indication: ESSENTIAL THROMBOCYTHAEMIA, Action: Drug Withdrawn, Additional: No
|
['xagrid']
|
['anagrelide hydrochloride']
|
['essential thrombocythaemia']
|
14,795,449
| 1
|
United States of America
|
Spontaneous
|
Yes
|
Death (Yes)
| 20,180,423
| 20,180,711
|
US-ENDO PHARMACEUTICALS INC-2018-035651
|
Regulatory Authority
|
FDA-Public Use
| null | null | null |
Death (Fatal)
|
ROXICODONE (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; EXALGO (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DILAUDID (Suspect), Active: HYDROMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NORCO (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYMORPHONE HCL (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCONTIN (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OXYCODONE HYDROCHLORIDE. (Suspect), Active: OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; KADIAN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROMORPHONE (Suspect), Active: HYDROMORPHONE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; FENTORA (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCODAN (Suspect), Active: ASPIRIN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYSINGLA ER (Suspect), Active: HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; NUCYNTA (Suspect), Active: TAPENTADOL HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; DURAGESIC (Suspect), Active: FENTANYL, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; PERCOCET (Suspect), Active: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ACTIQ (Suspect), Active: FENTANYL CITRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; HYDROCODONE BITARTRATE / ACETAMINOPHEN (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; OPANA ER (Suspect), Active: OXYMORPHONE HYDROCHLORIDE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; ZYDONE (Suspect), Active: ACETAMINOPHEN\HYDROCODONE BITARTRATE, Dosage: UNK UNKNOWN, UNKNOWN, Action: Not applicable; BUTRANS (Suspect), Active: BUPRENORPHINE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable; MS CONTIN (Suspect), Active: MORPHINE SULFATE, Dosage: UNK UNKNOWN, UNKNOWN, Indication: PAIN, Action: Not applicable
|
['butrans', 'percodan', 'exalgo', 'oxycodone hydrochloride.', 'duragesic', 'hydromorphone', 'hysingla er', 'norco', 'opana', 'actiq', 'zydone', 'hydrocodone bitartrate / acetaminophen', 'fentora', 'kadian', 'roxicodone', 'percocet', 'opana er', 'oxycontin', 'ms contin', 'nucynta', 'oxymorphone hcl', 'dilaudid']
|
['acetaminophen\\hydrocodone bitartrate', 'buprenorphine', 'fentanyl', 'oxycodone hydrochloride', 'hydrocodone bitartrate', 'fentanyl citrate', 'hydromorphone hydrochloride', 'aspirin\\oxycodone hydrochloride', 'hydromorphone', 'tapentadol hydrochloride', 'morphine sulfate', 'acetaminophen\\oxycodone hydrochloride', 'oxymorphone hydrochloride']
|
['pain']
|
14,795,834
| 1
|
France
|
Spontaneous
|
Yes
|
Hospitalization (Yes)
| 20,180,423
| 20,180,711
|
FR-TEVA-2018-FR-884618
|
Regulatory Authority
|
FDA-Public Use
| 65
|
Year
|
Female
|
Posterior reversible encephalopathy syndrome (Recovering / Resolving)
|
ATENOLOL. (Suspect), Active: ATENOLOL, Indication: ATRIAL FIBRILLATION, Action: Dose Increased; LASILIX (Suspect), Active: FUROSEMIDE, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; XARELTO (Suspect), Active: RIVAROXABAN, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes; HYDREA (Suspect), Active: HYDROXYUREA, Indication: POLYCYTHAEMIA VERA, Action: Dose not changed; CORDARONE (Suspect), Active: AMIODARONE HYDROCHLORIDE, Dosage: SCORED TABLET, Indication: ATRIAL FIBRILLATION, Action: Drug Withdrawn, Additional: Yes
|
['hydrea', 'atenolol.', 'cordarone', 'lasilix', 'xarelto']
|
['rivaroxaban', 'furosemide', 'hydroxyurea', 'atenolol', 'amiodarone hydrochloride']
|
['atrial fibrillation', 'polycythaemia vera']
|
14,796,117
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018008877
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Female
|
Rhinorrhoea (Recovered / Resolved); Injection site bruising (Recovering / Resolving); Sneezing (Recovered / Resolved)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG/ML, 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']
|
14,796,132
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018008908
|
Regulatory Authority
|
FDA-Public Use
| 62
|
Year
|
Female
|
Injection site pain (Recovering / Resolving)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: BLOOD CHOLESTEROL ABNORMAL, Action: Unknown, Additional: Doesn't Apply
|
['repatha']
|
['evolocumab']
|
['blood cholesterol abnormal']
|
14,796,384
| 1
|
United States of America
|
Report from study
|
Yes
|
Other (Yes)
| 20,180,423
| 20,180,711
|
US-AMGEN-USASL2018007830
|
Regulatory Authority
|
FDA-Public Use
| 58
|
Year
|
Male
|
Oropharyngeal pain (Not Recovered / Not Resolved / Ongoing); Blood glucose increased (Recovered / Resolved); Tremor (Not Recovered / Not Resolved / Ongoing); Muscle spasms (Not Recovered / Not Resolved / Ongoing); Gait inability (Not Recovered / Not Resolved / Ongoing)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Indication: BLOOD CHOLESTEROL INCREASED, Action: Drug Withdrawn, Additional: Yes; REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: BLOOD TRIGLYCERIDES INCREASED, Action: Drug Withdrawn, Additional: Yes
|
['repatha']
|
['evolocumab']
|
['blood cholesterol increased', 'blood triglycerides increased']
|
14,796,397
| 1
|
United States of America
|
Report from study
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASL2017192878
|
Regulatory Authority
|
FDA-Public Use
| 68
|
Year
|
Male
|
Hypersensitivity (Not Recovered / Not Resolved / Ongoing); Rash (Recovered / Resolved); Bronchitis (Not Recovered / Not Resolved / Ongoing); Influenza (Not Recovered / Not Resolved / Ongoing); Pruritus (Recovered / Resolved)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: 140 MG, Q2WK, Indication: HYPERLIPIDAEMIA, Action: Drug Withdrawn, Additional: Yes; ALDACTONE (Suspect), Active: SPIRONOLACTONE, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Unknown
|
['repatha', 'aldactone']
|
['spironolactone', 'evolocumab']
|
['hyperlipidaemia', 'product used for unknown indication']
|
14,796,698
| 1
|
United States of America
|
Spontaneous
|
No
| null | 20,180,423
| 20,180,711
|
US-AMGEN-USASP2018048905
|
Regulatory Authority
|
FDA-Public Use
| null | null |
Female
|
Injection site reaction (Not Recovered / Not Resolved / Ongoing)
|
REPATHA (Suspect), Active: EVOLOCUMAB, Dosage: UNK, Indication: PRODUCT USED FOR UNKNOWN INDICATION, Action: Drug Withdrawn, Additional: No
|
['repatha']
|
['evolocumab']
|
['product used for unknown indication']
|
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