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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944833 | 12594483 | 3 | F | 20160809 | 20160726 | 20160823 | EXP | US-AUROBINDO-AUR-APL-2016-09671 | AUROBINDO | 25.00 | YR | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944833 | 12594483 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | 100 MG, TWO TIMES A DAY | Y | U | 78462 | 100 | MG | BID | |||||
| 125944833 | 12594483 | 2 | SS | PHENYTOIN. | PHENYTOIN | 1 | Unknown | 300 MG, UNK | U | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944833 | 12594483 | 1 | Seizure |
| 125944833 | 12594483 | 2 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125944833 | 12594483 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944833 | 12594483 | Decreased appetite | |
| 125944833 | 12594483 | Drug reaction with eosinophilia and systemic symptoms | |
| 125944833 | 12594483 | Face oedema | |
| 125944833 | 12594483 | Lymphadenopathy | |
| 125944833 | 12594483 | Malaise | |
| 125944833 | 12594483 | Nausea | |
| 125944833 | 12594483 | Oropharyngeal pain | |
| 125944833 | 12594483 | Pain | |
| 125944833 | 12594483 | Pallor | |
| 125944833 | 12594483 | Papule | |
| 125944833 | 12594483 | Petechiae | |
| 125944833 | 12594483 | Pyrexia | |
| 125944833 | 12594483 | Rash | |
| 125944833 | 12594483 | Rash pruritic | |
| 125944833 | 12594483 | Skin erosion | |
| 125944833 | 12594483 | Swelling face |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |