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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127275621 | 12727562 | 1 | I | 20160628 | 20160826 | 20160909 | 20160909 | EXP | GB-MHRA-EYC 00144230 | GB-LUPIN PHARMACEUTICALS INC.-E2B_00006080 | LUPIN | 43.00 | YR | F | Y | 60.32000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127275621 | 12727562 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | Y | U | UNKNOWN | 77670 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127275621 | 12727562 | 1 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127275621 | 12727562 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127275621 | 12727562 | Abnormal dreams | |
| 127275621 | 12727562 | Anxiety | |
| 127275621 | 12727562 | Blepharospasm | |
| 127275621 | 12727562 | Bruxism | |
| 127275621 | 12727562 | Decreased appetite | |
| 127275621 | 12727562 | Depression | |
| 127275621 | 12727562 | Diarrhoea | |
| 127275621 | 12727562 | Dizziness | |
| 127275621 | 12727562 | Essential tremor | |
| 127275621 | 12727562 | Fatigue | |
| 127275621 | 12727562 | Headache | |
| 127275621 | 12727562 | Hot flush | |
| 127275621 | 12727562 | Hypoglycaemia | |
| 127275621 | 12727562 | Insomnia | |
| 127275621 | 12727562 | Muscle twitching | |
| 127275621 | 12727562 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 127275621 | 12727562 | 1 | 20160628 | 0 |