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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127636631 | 12763663 | 1 | I | 20160909 | 20160920 | 20160920 | EXP | US-UNICHEM LABORATORIES LIMITED-UCM201609-000207 | UNICHEM | 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. J PEDIATR GASTROENTEROL NUTR 2014 SEP;63(3):E-37-8. | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127636631 | 12763663 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Y | N | 90162 | ||||||||||
127636631 | 12763663 | 2 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | 0 | ||||||||||||
127636631 | 12763663 | 3 | C | DIAZEPAM. | DIAZEPAM | 1 | 0 | ||||||||||||
127636631 | 12763663 | 4 | C | BACLOFEN. | BACLOFEN | 1 | 0 |
Indications of drugs used
no results found |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127636631 | 12763663 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127636631 | 12763663 | Acidosis | |
127636631 | 12763663 | Acute hepatic failure | |
127636631 | 12763663 | Acute kidney injury | |
127636631 | 12763663 | Coagulopathy | |
127636631 | 12763663 | Hepatic encephalopathy | |
127636631 | 12763663 | Hyperammonaemia | |
127636631 | 12763663 | Hypovolaemic shock | |
127636631 | 12763663 | Liver injury | |
127636631 | 12763663 | 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 |