Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125631052 | 12563105 | 2 | F | 20160831 | 20160715 | 20160907 | EXP | GB-MYLANLABS-2016M1028520 | MYLAN | 0.00 | Y | 0.00000 | 20160907 | MD | GB | GB |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125631052 | 12563105 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MG, UNK (WITHDRAWN BEFORE 13-JUN-2016) | Y | U | 78626 | 50 | MG | ||||||
| 125631052 | 12563105 | 2 | C | ASPIRIN /00002701/ | ASPIRIN | 1 | Oral | 75 MG, UNK | U | 0 | 75 | MG | |||||||
| 125631052 | 12563105 | 3 | C | ATORVASTATIN /01326102/ | ATORVASTATIN | 1 | Oral | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 125631052 | 12563105 | 4 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | 15 MG, UNK (AS NECESSARY, PRN BASIS ) | U | 0 | 15 | MG | |||||||
| 125631052 | 12563105 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 20 MG, UNK | U | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125631052 | 12563105 | 1 | Stress |
| 125631052 | 12563105 | 2 | Prophylaxis |
| 125631052 | 12563105 | 3 | Prophylaxis |
| 125631052 | 12563105 | 5 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125631052 | 12563105 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125631052 | 12563105 | Amnesia | |
| 125631052 | 12563105 | Anger | |
| 125631052 | 12563105 | Asthenia | |
| 125631052 | 12563105 | Decreased appetite | |
| 125631052 | 12563105 | Diarrhoea | |
| 125631052 | 12563105 | Disturbance in attention | |
| 125631052 | 12563105 | Dizziness postural | |
| 125631052 | 12563105 | Dyskinesia | |
| 125631052 | 12563105 | Eye pain | |
| 125631052 | 12563105 | Haemorrhage subcutaneous | |
| 125631052 | 12563105 | Headache | |
| 125631052 | 12563105 | Heart rate increased | |
| 125631052 | 12563105 | Mental disorder | |
| 125631052 | 12563105 | Nausea | |
| 125631052 | 12563105 | Palpitations | |
| 125631052 | 12563105 | Psychiatric symptom | |
| 125631052 | 12563105 | Somnolence | |
| 125631052 | 12563105 | Thinking abnormal | |
| 125631052 | 12563105 | Tinnitus | |
| 125631052 | 12563105 | Vertigo |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125631052 | 12563105 | 1 | 20160602 | 0 | ||
| 125631052 | 12563105 | 2 | 20141113 | 0 | ||
| 125631052 | 12563105 | 3 | 20141223 | 0 | ||
| 125631052 | 12563105 | 4 | 20160125 | 0 | ||
| 125631052 | 12563105 | 5 | 20150402 | 0 |