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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126387671 | 12638767 | 1 | I | 20160705 | 20160802 | 20160809 | 20160809 | EXP | FR-SA-2016SA142544 | AVENTIS | 54.00 | YR | A | F | Y | 0.00000 | 20160809 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126387671 | 12638767 | 1 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | Y | UNKNOWN | 0 | |||||||||
| 126387671 | 12638767 | 2 | SS | GARDENAL | PHENOBARBITAL | 1 | Oral | Y | UNKNOWN | 0 | |||||||||
| 126387671 | 12638767 | 3 | SS | URBANYL | CLOBAZAM | 1 | Oral | Y | UNKNOWN | 0 | 10 | MG | TID | ||||||
| 126387671 | 12638767 | 4 | PS | STILNOX | ZOLPIDEM TARTRATE | 1 | Oral | 10 MG, FILM COATED DIVISIBLE TABLET | Y | UNKNOWN | 19908 | 10 | MG | FILM-COATED TABLET | QD | ||||
| 126387671 | 12638767 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, FILM COATED TABLET?1.5 TABLET MORNING AND EVENING | Y | UNKNOWN | 0 | 1.5 | DF | FILM-COATED TABLET | BID | ||||
| 126387671 | 12638767 | 6 | SS | DI-HYDAN | PHENYTOIN | 1 | Oral | 100 MG COMPRESSED TABLET | Y | UNKNOWN | 0 | TABLET | |||||||
| 126387671 | 12638767 | 7 | SS | HALDOL | HALOPERIDOL | 1 | Oral | Y | UNKNOWN | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126387671 | 12638767 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126387671 | 12638767 | Brain oedema | |
| 126387671 | 12638767 | Bronchial obstruction | |
| 126387671 | 12638767 | Cardio-respiratory arrest | |
| 126387671 | 12638767 | Coma | |
| 126387671 | 12638767 | Hypoxic-ischaemic encephalopathy | |
| 126387671 | 12638767 | Intracranial pressure increased | |
| 126387671 | 12638767 | Mydriasis | |
| 126387671 | 12638767 | Pupils unequal | |
| 126387671 | 12638767 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |