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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119083222 | 11908322 | 2 | F | 20160627 | 20160111 | 20160712 | EXP | US-APOTEX-2016AP005202 | APOTEX | 0.00 | F | Y | 0.00000 | 20160712 | CN | GB | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119083222 | 11908322 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | 20031 | TABLET | |||||||||
| 119083222 | 11908322 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | 20031 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119083222 | 11908322 | 1 | Menopausal depression |
| 119083222 | 11908322 | 2 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119083222 | 11908322 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119083222 | 11908322 | Abnormal dreams | |
| 119083222 | 11908322 | Agitation | |
| 119083222 | 11908322 | Anxiety | |
| 119083222 | 11908322 | Asthenia | |
| 119083222 | 11908322 | Balance disorder | |
| 119083222 | 11908322 | Confusional state | |
| 119083222 | 11908322 | Depression | |
| 119083222 | 11908322 | Disturbance in attention | |
| 119083222 | 11908322 | Dizziness | |
| 119083222 | 11908322 | Drug dependence | |
| 119083222 | 11908322 | Drug ineffective | |
| 119083222 | 11908322 | Fatigue | |
| 119083222 | 11908322 | Frustration tolerance decreased | |
| 119083222 | 11908322 | Headache | |
| 119083222 | 11908322 | Impaired work ability | |
| 119083222 | 11908322 | Insomnia | |
| 119083222 | 11908322 | Irritability | |
| 119083222 | 11908322 | Mood altered | |
| 119083222 | 11908322 | Nightmare | |
| 119083222 | 11908322 | Performance status decreased | |
| 119083222 | 11908322 | Restless legs syndrome | |
| 119083222 | 11908322 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 119083222 | 11908322 | 1 | 2006 | 0 |