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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127577681 | 12757768 | 1 | I | 20160906 | 20160919 | 20160919 | EXP | US-APOTEX-2016AP011399 | APOTEX | DELEMOS AS, GHABRIL M, ROCKEY DC, GU J, BARNHART HX, FONTANA RJ, ET AL.. AMOXICILLIN-CLAVULANATE-INDUCED LIVER INJURY.. DIG-DIS-SCI. 2016;61(8):2406-2416 | 65.00 | YR | F | Y | 0.00000 | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127577681 | 12757768 | 1 | PS | AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Unknown | D | 65317 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127577681 | 12757768 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127577681 | 12757768 | OT |
| 127577681 | 12757768 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127577681 | 12757768 | Drug-induced liver injury | |
| 127577681 | 12757768 | Hepatic necrosis | |
| 127577681 | 12757768 | Hepatic steatosis | |
| 127577681 | 12757768 | Hepatitis | |
| 127577681 | 12757768 | Hepatocellular injury |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |