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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978632 | 12497863 | 2 | F | 20010630 | 20160627 | 20160625 | 20160707 | EXP | GB-APOTEX-2016AP009445 | APOTEX | 0.00 | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978632 | 12497863 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, QD | 1040 | MG | U | U | 20031 | 20 | MG | TABLET | |||
| 124978632 | 12497863 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124978632 | 12497863 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978632 | 12497863 | 1 | Depression |
| 124978632 | 12497863 | 2 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978632 | 12497863 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978632 | 12497863 | Abdominal pain upper | |
| 124978632 | 12497863 | Abnormal behaviour | |
| 124978632 | 12497863 | Aggression | |
| 124978632 | 12497863 | Decreased appetite | |
| 124978632 | 12497863 | Dependence | |
| 124978632 | 12497863 | Disturbance in attention | |
| 124978632 | 12497863 | Dizziness | |
| 124978632 | 12497863 | Drug withdrawal syndrome | |
| 124978632 | 12497863 | Insomnia | |
| 124978632 | 12497863 | Intentional self-injury | |
| 124978632 | 12497863 | Mania | |
| 124978632 | 12497863 | Memory impairment | |
| 124978632 | 12497863 | Suicidal ideation | |
| 124978632 | 12497863 | Vision blurred | |
| 124978632 | 12497863 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124978632 | 12497863 | 1 | 20010420 | 20010611 | 0 | |
| 124978632 | 12497863 | 2 | 20010420 | 0 | ||
| 124978632 | 12497863 | 3 | 20050204 | 0 |