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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126392411 | 12639241 | 1 | I | 20160728 | 20160810 | 20160810 | EXP | US-ZYDUS-011832 | ZYDUS PHARM | GLEESON TP, GRISWOLD MK, BROACH J, BABU KM. WHAT IS THIS RASH? J-MED-TOXICOL 2016;12 (2):199-200. | 25.00 | YR | M | Y | 0.00000 | 20160810 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126392411 | 12639241 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | Y | UNKNOWN | 78235 | 100 | MG | BID | ||||||
| 126392411 | 12639241 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | UNKNOWN | 78918 | |||||||||
| 126392411 | 12639241 | 3 | SS | PHENYTOIN. | PHENYTOIN | 1 | Unknown | Y | UNKNOWN | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126392411 | 12639241 | 1 | Seizure |
| 126392411 | 12639241 | 2 | Seizure |
| 126392411 | 12639241 | 3 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126392411 | 12639241 | HO |
| 126392411 | 12639241 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126392411 | 12639241 | Abdominal pain | |
| 126392411 | 12639241 | Condition aggravated | |
| 126392411 | 12639241 | Decreased appetite | |
| 126392411 | 12639241 | Drug reaction with eosinophilia and systemic symptoms | |
| 126392411 | 12639241 | Face oedema | |
| 126392411 | 12639241 | Lymphadenopathy | |
| 126392411 | 12639241 | Mouth ulceration | |
| 126392411 | 12639241 | Nausea | |
| 126392411 | 12639241 | Oropharyngeal pain | |
| 126392411 | 12639241 | Pallor | |
| 126392411 | 12639241 | Petechiae | |
| 126392411 | 12639241 | Pyrexia | |
| 126392411 | 12639241 | Rash erythematous | |
| 126392411 | 12639241 | Rash morbilliform | |
| 126392411 | 12639241 | Rash pruritic | |
| 126392411 | 12639241 | Swelling face |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |