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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978402 | 12497840 | 2 | F | 20021016 | 20160712 | 20160625 | 20160721 | EXP | GB-APOTEX-2016AP009327 | APOTEX | 25.00 | YR | F | Y | 0.00000 | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978402 | 12497840 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | U | U | 20031 | 20 | MG | TABLET | QD | |||||
| 124978402 | 12497840 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | U | U | 0 | TABLET | |||||||
| 124978402 | 12497840 | 3 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | U | U | 0 | ORAL SOLUTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978402 | 12497840 | 1 | Anxiety |
| 124978402 | 12497840 | 2 | Panic attack |
| 124978402 | 12497840 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978402 | 12497840 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978402 | 12497840 | Agitation | |
| 124978402 | 12497840 | Anxiety | |
| 124978402 | 12497840 | Confusional state | |
| 124978402 | 12497840 | Diplopia | |
| 124978402 | 12497840 | Disturbance in attention | |
| 124978402 | 12497840 | Dizziness | |
| 124978402 | 12497840 | Drug withdrawal syndrome | |
| 124978402 | 12497840 | Emotional poverty | |
| 124978402 | 12497840 | Eyelid ptosis | |
| 124978402 | 12497840 | Fatigue | |
| 124978402 | 12497840 | Hallucination | |
| 124978402 | 12497840 | Hallucination, auditory | |
| 124978402 | 12497840 | Hallucination, visual | |
| 124978402 | 12497840 | Headache | |
| 124978402 | 12497840 | Hyperhidrosis | |
| 124978402 | 12497840 | Influenza like illness | |
| 124978402 | 12497840 | Insomnia | |
| 124978402 | 12497840 | Lethargy | |
| 124978402 | 12497840 | Memory impairment | |
| 124978402 | 12497840 | Nausea | |
| 124978402 | 12497840 | Nightmare | |
| 124978402 | 12497840 | Panic attack | |
| 124978402 | 12497840 | Paraesthesia | |
| 124978402 | 12497840 | Self-injurious ideation | |
| 124978402 | 12497840 | Suicidal ideation | |
| 124978402 | 12497840 | Tremor | |
| 124978402 | 12497840 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 124978402 | 12497840 | 1 | 20020204 | 0 | ||
| 124978402 | 12497840 | 3 | 20030422 | 20030828 | 0 |