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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944841 | 12594484 | 1 | I | 20160712 | 20160726 | 20160726 | EXP | US-AUROBINDO-AUR-APL-2016-09544 | AUROBINDO | 16.00 | YR | M | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125944841 | 12594484 | 1 | PS | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | U | U | 65256 | |||||||||
| 125944841 | 12594484 | 2 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125944841 | 12594484 | 1 | Pharyngitis streptococcal |
| 125944841 | 12594484 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125944841 | 12594484 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125944841 | 12594484 | Abdominal pain | |
| 125944841 | 12594484 | Alanine aminotransferase increased | |
| 125944841 | 12594484 | Aspartate aminotransferase increased | |
| 125944841 | 12594484 | Drug interaction | |
| 125944841 | 12594484 | Drug reaction with eosinophilia and systemic symptoms | |
| 125944841 | 12594484 | Eosinophil count increased | |
| 125944841 | 12594484 | Hyponatraemia | |
| 125944841 | 12594484 | Liver injury | |
| 125944841 | 12594484 | Lymphadenopathy | |
| 125944841 | 12594484 | Pyrexia | |
| 125944841 | 12594484 | Rash erythematous | |
| 125944841 | 12594484 | Rash pruritic |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |