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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978794 | 12497879 | 4 | F | 19940331 | 20160728 | 20160625 | 20160811 | EXP | GB-APOTEX-2016AP009317 | APOTEX | 47.00 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978794 | 12497879 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | UNK | U | 20031 | TABLET | ||||||||
| 124978794 | 12497879 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | 1560 | MG | U | 0 | 20 | MG | TABLET | ||||
| 124978794 | 12497879 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | UNK | 1560 | MG | U | 0 | TABLET | |||||||
| 124978794 | 12497879 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | TABLET | ||||||||
| 124978794 | 12497879 | 5 | C | PYRIDOXINE HYDROCHLORIDE. | PYRIDOXINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978794 | 12497879 | 1 | Depression |
| 124978794 | 12497879 | 2 | Depression |
| 124978794 | 12497879 | 4 | Depression |
| 124978794 | 12497879 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978794 | 12497879 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978794 | 12497879 | Aggression | |
| 124978794 | 12497879 | Anger | |
| 124978794 | 12497879 | Anxiety | |
| 124978794 | 12497879 | Apathy | |
| 124978794 | 12497879 | Asthenia | |
| 124978794 | 12497879 | Back pain | |
| 124978794 | 12497879 | Depersonalisation/derealisation disorder | |
| 124978794 | 12497879 | Depression | |
| 124978794 | 12497879 | Diarrhoea | |
| 124978794 | 12497879 | Disorientation | |
| 124978794 | 12497879 | Dissociation | |
| 124978794 | 12497879 | Disturbance in attention | |
| 124978794 | 12497879 | Fatigue | |
| 124978794 | 12497879 | Feeling of despair | |
| 124978794 | 12497879 | Frustration tolerance decreased | |
| 124978794 | 12497879 | Irritability | |
| 124978794 | 12497879 | Memory impairment | |
| 124978794 | 12497879 | Mood swings | |
| 124978794 | 12497879 | Myalgia | |
| 124978794 | 12497879 | Nausea | |
| 124978794 | 12497879 | Neck pain | |
| 124978794 | 12497879 | Paraesthesia | |
| 124978794 | 12497879 | Sexual dysfunction | |
| 124978794 | 12497879 | Sleep disorder | |
| 124978794 | 12497879 | Suicidal ideation | |
| 124978794 | 12497879 | Weight fluctuation | |
| 124978794 | 12497879 | 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 |
|---|---|---|---|---|---|---|
| 124978794 | 12497879 | 1 | 19941110 | 19980417 | 0 | |
| 124978794 | 12497879 | 2 | 19940112 | 19940331 | 0 | |
| 124978794 | 12497879 | 3 | 19940331 | 0 | ||
| 124978794 | 12497879 | 4 | 20071002 | 0 | ||
| 124978794 | 12497879 | 5 | 19980827 | 0 |