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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127984691 | 12798469 | 1 | I | 20160923 | 20160930 | 20160930 | EXP | US-MYLANLABS-2016M1041818 | MYLAN | TSIEN MZ, CORDOVA J, QADIR A, ZHAO L, HART J, AZZAM R. TOPIRAMATE-INDUCED ACUTE LIVER FAILURE IN A PEDIATRIC PATIENT: A CASE REPORT AND REVIEW OF LITERATURE. J-PEDIATR-GASTROENTEROL-NUTR 2016;63(3):E37-E38. | 0.00 | Y | 0.00000 | 20160930 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127984691 | 12798469 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | U | 76314 | |||||||||
| 127984691 | 12798469 | 2 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | D | 0 | ||||||||||
| 127984691 | 12798469 | 3 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | D | 0 | ||||||||||
| 127984691 | 12798469 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127984691 | 12798469 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127984691 | 12798469 | OT |
| 127984691 | 12798469 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127984691 | 12798469 | Acute hepatic failure | |
| 127984691 | 12798469 | Diarrhoea | |
| 127984691 | 12798469 | Drug-induced liver injury | |
| 127984691 | 12798469 | Hyperammonaemic encephalopathy | |
| 127984691 | 12798469 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |