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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125257321 | 12525732 | 1 | I | 20160622 | 20160705 | 20160705 | EXP | US-ZYDUS-011486 | ZYDUS PHARM | SHARMA R, BOHN D, SHARMA N, STANFORD R. FOCAL FATTY INFILTRATION OF THE LIVER AS A POSSIBLE RARE SIDE EFFECT OF GABAPENTIN: CASE REPORT OF A 14 YEAR OLD FEMALE DEVELOPING ABDOMINAL SYMPTOMS FOLLOWING INITIATION OF TREATMENT. PEDIATR-RADIOL 2016;46 (SUPPL. S209) (PLUS POSTER) ABSTR. CR-038. | 14.00 | YR | T | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125257321 | 12525732 | 1 | PS | GABAPENTIN. | GABAPENTIN | 1 | Oral | 100 MG ONE TO TWO CAPSULES THRICE A DAY | UNKNOWN | 78926 | CAPSULE | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125257321 | 12525732 | 1 | Ear pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125257321 | 12525732 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125257321 | 12525732 | Abdominal pain upper | |
| 125257321 | 12525732 | Hepatic lesion | |
| 125257321 | 12525732 | Hepatic steatosis | |
| 125257321 | 12525732 | Hepatotoxicity | |
| 125257321 | 12525732 | Nausea | |
| 125257321 | 12525732 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |