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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127161983 | 12716198 | 3 | F | 20160912 | 20160906 | 20160926 | EXP | US-AUROBINDO-AUR-APL-2016-11231 | AUROBINDO | 46.00 | YR | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127161983 | 12716198 | 1 | PS | LOPERAMIDE HCL | LOPERAMIDE HYDROCHLORIDE | 1 | 50 DF, UNK | D | U | 206548 | 50 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127161983 | 12716198 | 1 | Irritable bowel syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127161983 | 12716198 | OT |
| 127161983 | 12716198 | HO |
| 127161983 | 12716198 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127161983 | 12716198 | Amnesia | |
| 127161983 | 12716198 | Cardiac arrest | |
| 127161983 | 12716198 | Dizziness | |
| 127161983 | 12716198 | Drug abuse | |
| 127161983 | 12716198 | Electrocardiogram QT prolonged | |
| 127161983 | 12716198 | Electrocardiogram T wave abnormal | |
| 127161983 | 12716198 | Haemodynamic instability | |
| 127161983 | 12716198 | Loss of consciousness | |
| 127161983 | 12716198 | Overdose | |
| 127161983 | 12716198 | Self-medication | |
| 127161983 | 12716198 | Torsade de pointes | |
| 127161983 | 12716198 | Toxicity to various agents | |
| 127161983 | 12716198 | Ventricular arrhythmia | |
| 127161983 | 12716198 | Ventricular fibrillation | |
| 127161983 | 12716198 | Ventricular tachycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |