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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124012824 | 12401282 | 4 | F | 2014 | 20160622 | 20160525 | 20160706 | EXP | CN-APOTEX-2016AP008529 | APOTEX | 42.00 | YR | F | Y | 57.00000 | KG | 20160706 | CN | GB | CN |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124012824 | 12401282 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 20031 | TABLET | ||||||||
| 124012824 | 12401282 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30 MG, QD | Y | 20031 | 30 | MG | TABLET | ||||||
| 124012824 | 12401282 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 15060120; | 20031 | TABLET | |||||||
| 124012824 | 12401282 | 4 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | UNK | Y | 0 | |||||||||
| 124012824 | 12401282 | 5 | SS | ZOLOFT | SERTRALINE HYDROCHLORIDE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124012824 | 12401282 | 1 | Anxiety |
| 124012824 | 12401282 | 2 | Panic disorder |
| 124012824 | 12401282 | 4 | Anxiety |
| 124012824 | 12401282 | 5 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124012824 | 12401282 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124012824 | 12401282 | Abdominal discomfort | |
| 124012824 | 12401282 | Abdominal pain | |
| 124012824 | 12401282 | Abnormal faeces | |
| 124012824 | 12401282 | Anxiety | |
| 124012824 | 12401282 | Blood pressure increased | |
| 124012824 | 12401282 | Bruxism | |
| 124012824 | 12401282 | Discomfort | |
| 124012824 | 12401282 | Disease recurrence | |
| 124012824 | 12401282 | Dry mouth | |
| 124012824 | 12401282 | Fatigue | |
| 124012824 | 12401282 | Haematochezia | |
| 124012824 | 12401282 | Hyperhidrosis | |
| 124012824 | 12401282 | Hypoaesthesia | |
| 124012824 | 12401282 | Insomnia | |
| 124012824 | 12401282 | Menstrual disorder | |
| 124012824 | 12401282 | Menstruation irregular | |
| 124012824 | 12401282 | Movement disorder | |
| 124012824 | 12401282 | Nausea | |
| 124012824 | 12401282 | Nightmare | |
| 124012824 | 12401282 | Nocturia | |
| 124012824 | 12401282 | Somnolence | |
| 124012824 | 12401282 | Tinnitus | |
| 124012824 | 12401282 | Vascular headache | |
| 124012824 | 12401282 | Vision blurred | |
| 124012824 | 12401282 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124012824 | 12401282 | 1 | 2014 | 20160515 | 0 | |
| 124012824 | 12401282 | 2 | 2014 | 0 | ||
| 124012824 | 12401282 | 4 | 2015 | 201511 | 0 | |
| 124012824 | 12401282 | 5 | 2016 | 0 |