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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978392 | 12497839 | 2 | F | 200310 | 20160627 | 20160625 | 20160707 | EXP | GB-APOTEX-2016AP009306 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978392 | 12497839 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | UNK | 20031 | TABLET | |||||||||
| 124978392 | 12497839 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 30 MG, QD | 20031 | 30 | MG | TABLET | QD | ||||||
| 124978392 | 12497839 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 20 MG, BID | 20031 | 20 | MG | TABLET | BID | ||||||
| 124978392 | 12497839 | 4 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 40 MG, QD | 20031 | 40 | MG | TABLET | QD | ||||||
| 124978392 | 12497839 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, QD | 0 | TABLET | |||||||||
| 124978392 | 12497839 | 6 | C | Cipramil | CITALOPRAM HYDROBROMIDE | 1 | U | 0 | |||||||||||
| 124978392 | 12497839 | 7 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 124978392 | 12497839 | 8 | C | DIAZEPAM. | DIAZEPAM | 1 | U | 0 | |||||||||||
| 124978392 | 12497839 | 9 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978392 | 12497839 | 1 | Depression |
| 124978392 | 12497839 | 5 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978392 | 12497839 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978392 | 12497839 | Agitation | |
| 124978392 | 12497839 | Anxiety | |
| 124978392 | 12497839 | Confusional state | |
| 124978392 | 12497839 | Disturbance in attention | |
| 124978392 | 12497839 | Dizziness | |
| 124978392 | 12497839 | Drug withdrawal syndrome | |
| 124978392 | 12497839 | Fatigue | |
| 124978392 | 12497839 | Hallucination | |
| 124978392 | 12497839 | Hyperhidrosis | |
| 124978392 | 12497839 | Influenza | |
| 124978392 | 12497839 | Insomnia | |
| 124978392 | 12497839 | Intentional self-injury | |
| 124978392 | 12497839 | Lethargy | |
| 124978392 | 12497839 | Memory impairment | |
| 124978392 | 12497839 | Nightmare | |
| 124978392 | 12497839 | Paraesthesia | |
| 124978392 | 12497839 | Persistent depressive disorder | |
| 124978392 | 12497839 | Personality disorder | |
| 124978392 | 12497839 | Suicidal ideation | |
| 124978392 | 12497839 | Suicide attempt | |
| 124978392 | 12497839 | Tremor | |
| 124978392 | 12497839 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 124978392 | 12497839 | 1 | 2002 | 20031212 | 0 | |
| 124978392 | 12497839 | 2 | 2002 | 20030801 | 0 | |
| 124978392 | 12497839 | 3 | 20030228 | 20031106 | 0 | |
| 124978392 | 12497839 | 4 | 20031024 | 20031106 | 0 | |
| 124978392 | 12497839 | 5 | 20020926 | 200310 | 0 | |
| 124978392 | 12497839 | 6 | 20031021 | 0 | ||
| 124978392 | 12497839 | 7 | 20031219 | 0 | ||
| 124978392 | 12497839 | 8 | 20030901 | 0 | ||
| 124978392 | 12497839 | 9 | 20031121 | 0 |