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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978773 | 12497877 | 3 | F | 20050318 | 20160718 | 20160625 | 20160729 | EXP | GB-APOTEX-2016AP009386 | APOTEX | 52.00 | YR | M | Y | 0.00000 | 20160729 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978773 | 12497877 | 1 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, DAILY | U | U | 0 | 20 | MG | TABLET | |||||
| 124978773 | 12497877 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | |||||
| 124978773 | 12497877 | 3 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 20031 | TABLET | |||||||
| 124978773 | 12497877 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 40 MG, UNKNOWN | U | U | 20031 | 40 | MG | TABLET | |||||
| 124978773 | 12497877 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 20031 | 20 | MG | TABLET | |||||
| 124978773 | 12497877 | 6 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Unknown | 20 MG, Q.H.S. | U | U | 0 | 20 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978773 | 12497877 | 1 | Product used for unknown indication |
| 124978773 | 12497877 | 3 | Depression |
| 124978773 | 12497877 | 6 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978773 | 12497877 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978773 | 12497877 | Aggression | |
| 124978773 | 12497877 | Dizziness | |
| 124978773 | 12497877 | Drug withdrawal syndrome | |
| 124978773 | 12497877 | Headache | |
| 124978773 | 12497877 | Irritability | |
| 124978773 | 12497877 | Nausea | |
| 124978773 | 12497877 | Paraesthesia | |
| 124978773 | 12497877 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 124978773 | 12497877 | 1 | 20090520 | 0 | ||
| 124978773 | 12497877 | 2 | 20090527 | 0 | ||
| 124978773 | 12497877 | 3 | 19990506 | 0 | ||
| 124978773 | 12497877 | 5 | 1999 | 0 | ||
| 124978773 | 12497877 | 6 | 1992 | 0 |