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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127616941 | 12761694 | 1 | I | 20160905 | 20160920 | 20160920 | EXP | US-LUPIN PHARMACEUTICALS INC.-2016-04182 | LUPIN | TSIEN M, 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. JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION. 2014 SEP;63(3):E37-E38. | 11.00 | YR | M | Y | 0.00000 | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127616941 | 12761694 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 78410 | |||||||||
| 127616941 | 12761694 | 2 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Unknown | 0 | |||||||||||
| 127616941 | 12761694 | 3 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 0 | |||||||||||
| 127616941 | 12761694 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127616941 | 12761694 | 1 | Product used for unknown indication |
| 127616941 | 12761694 | 2 | Product used for unknown indication |
| 127616941 | 12761694 | 3 | Product used for unknown indication |
| 127616941 | 12761694 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127616941 | 12761694 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127616941 | 12761694 | Acute hepatic failure | |
| 127616941 | 12761694 | Hepatic encephalopathy | |
| 127616941 | 12761694 | Hyperammonaemia | |
| 127616941 | 12761694 | 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 |