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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113811064 | 11381106 | 4 | F | 20160622 | 20150814 | 20160707 | EXP | US-AUROBINDO-AUR-APL-2015-06852 | AUROBINDO | 82.00 | YR | F | Y | 0.00000 | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113811064 | 11381106 | 1 | PS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Unknown | Y | U | 77859 | |||||||||
| 113811064 | 11381106 | 2 | SS | CIPROFLOXACIN. | CIPROFLOXACIN | 1 | Y | U | 77859 | ||||||||||
| 113811064 | 11381106 | 3 | SS | METRONIDAZOLE. | METRONIDAZOLE | 1 | Unknown | U | U | 0 | |||||||||
| 113811064 | 11381106 | 4 | SS | METRONIDAZOLE. | METRONIDAZOLE | 1 | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113811064 | 11381106 | 1 | Colitis |
| 113811064 | 11381106 | 2 | Presyncope |
| 113811064 | 11381106 | 3 | Colitis |
| 113811064 | 11381106 | 4 | Presyncope |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113811064 | 11381106 | OT |
| 113811064 | 11381106 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113811064 | 11381106 | Alanine aminotransferase increased | |
| 113811064 | 11381106 | Aspartate aminotransferase increased | |
| 113811064 | 11381106 | Blood alkaline phosphatase increased | |
| 113811064 | 11381106 | Cholestatic liver injury | |
| 113811064 | 11381106 | Drug-induced liver injury | |
| 113811064 | 11381106 | Fatigue | |
| 113811064 | 11381106 | Hypotension | |
| 113811064 | 11381106 | Presyncope | |
| 113811064 | 11381106 | Sepsis | |
| 113811064 | 11381106 | Tachycardia | |
| 113811064 | 11381106 | Tachypnoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |