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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499601 | 12649960 | 1 | I | 20160801 | 20160813 | 20160813 | EXP | US-AUROBINDO-AUR-APL-2016-10209 | AUROBINDO | 0.00 | Y | 0.00000 | 20160813 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499601 | 12649960 | 1 | SS | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 750 MG, EVERY 6 HOURS | U | U | 0 | 750 | MG | ORAL LIQUID | |||||
| 126499601 | 12649960 | 2 | PS | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | 450 MG, EVERY 6 HOURS | Y | U | 65442 | 450 | MG | |||||||
| 126499601 | 12649960 | 3 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 400 MG, PRN | U | 0 | 400 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126499601 | 12649960 | 1 | Product used for unknown indication |
| 126499601 | 12649960 | 2 | Tooth infection |
| 126499601 | 12649960 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126499601 | 12649960 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126499601 | 12649960 | Drug-induced liver injury |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |