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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978502 | 12497850 | 2 | F | 2003 | 20160627 | 20160625 | 20160707 | EXP | GB-APOTEX-2016AP009385 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978502 | 12497850 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, UNKNOWN | U | 20031 | 20 | MG | TABLET | ||||||
| 124978502 | 12497850 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Unknown | 20 MG, 1D | U | 20031 | 20 | MG | TABLET | ||||||
| 124978502 | 12497850 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, QD | U | U | 0 | 20 | MG | TABLET | QD | ||||
| 124978502 | 12497850 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 3 MG TO 3.5 MG DAILY | U | U | 0 | TABLET | |||||||
| 124978502 | 12497850 | 5 | SS | Paroxetine Oral solution | PAROXETINE | 1 | Unknown | UNK | U | U | 0 | ORAL SOLUTION | |||||||
| 124978502 | 12497850 | 6 | C | DIAZEPAM. | DIAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 124978502 | 12497850 | 7 | C | ZOPICLONE | ZOPICLONE | 1 | 3.75 MG, UNK | U | 0 | 3.75 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978502 | 12497850 | 1 | Panic attack |
| 124978502 | 12497850 | 2 | Depression |
| 124978502 | 12497850 | 3 | Product used for unknown indication |
| 124978502 | 12497850 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978502 | 12497850 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978502 | 12497850 | Agitation | |
| 124978502 | 12497850 | Anxiety | |
| 124978502 | 12497850 | Confusional state | |
| 124978502 | 12497850 | Depressed mood | |
| 124978502 | 12497850 | Diarrhoea | |
| 124978502 | 12497850 | Disturbance in attention | |
| 124978502 | 12497850 | Dizziness | |
| 124978502 | 12497850 | Fear | |
| 124978502 | 12497850 | Feeling hot | |
| 124978502 | 12497850 | Hyperhidrosis | |
| 124978502 | 12497850 | Loss of consciousness | |
| 124978502 | 12497850 | Memory impairment | |
| 124978502 | 12497850 | Muscle spasms | |
| 124978502 | 12497850 | Nausea | |
| 124978502 | 12497850 | Nightmare | |
| 124978502 | 12497850 | Panic attack | |
| 124978502 | 12497850 | Paraesthesia | |
| 124978502 | 12497850 | Psychiatric symptom | |
| 124978502 | 12497850 | Sleep disorder | |
| 124978502 | 12497850 | Tremor | |
| 124978502 | 12497850 | Vision blurred | |
| 124978502 | 12497850 | Weight increased | |
| 124978502 | 12497850 | 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 |
|---|---|---|---|---|---|---|
| 124978502 | 12497850 | 2 | 19970902 | 0 | ||
| 124978502 | 12497850 | 3 | 19970926 | 0 | ||
| 124978502 | 12497850 | 4 | 20040607 | 0 | ||
| 124978502 | 12497850 | 5 | 20021014 | 20100427 | 0 | |
| 124978502 | 12497850 | 6 | 20030121 | 0 | ||
| 124978502 | 12497850 | 7 | 20021223 | 0 |