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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127740261 | 12774026 | 1 | I | 20160908 | 20160923 | 20160923 | EXP | US-AUROBINDO-AUR-APL-2016-11868 | AUROBINDO | 10.00 | YR | M | Y | 0.00000 | 20160923 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127740261 | 12774026 | 1 | PS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 500 MG, UNK | Y | U | 77095 | 500 | MG | ||||||
| 127740261 | 12774026 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127740261 | 12774026 | 1 | Product used for unknown indication |
| 127740261 | 12774026 | 2 | Mania |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127740261 | 12774026 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127740261 | 12774026 | Erythema | |
| 127740261 | 12774026 | Flushing | |
| 127740261 | 12774026 | Increased appetite | |
| 127740261 | 12774026 | Pruritus | |
| 127740261 | 12774026 | Rash | |
| 127740261 | 12774026 | Type I hypersensitivity | |
| 127740261 | 12774026 | Urticaria | |
| 127740261 | 12774026 | Weight increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |