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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125690051 | 12569005 | 1 | I | 20160521 | 20160705 | 20160719 | 20160719 | EXP | GB-AUROBINDO-AUR-APL-2016-08875 | AUROBINDO | 89.00 | YR | F | Y | 0.00000 | 20160719 | PH | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125690051 | 12569005 | 1 | PS | Omeprazole Gastro-resistant Capsule | OMEPRAZOLE | 1 | Oral | 20 MG, ONCE A DAY | Y | U | 203270 | 20 | MG | GASTRO-RESISTANT CAPSULE, HARD | QD | ||||
| 125690051 | 12569005 | 2 | SS | Ramipril capsules 5mg | RAMIPRIL | 1 | Oral | 5 MG, TWO TIMES A DAY | Y | U | 0 | 5 | MG | CAPSULE | BID | ||||
| 125690051 | 12569005 | 3 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, ONCE A DAY | Y | U | 0 | 25 | MG | TABLET | QD | ||||
| 125690051 | 12569005 | 4 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Oral | 25 MG, ONCE A DAY | U | 0 | 25 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125690051 | 12569005 | 1 | Product used for unknown indication |
| 125690051 | 12569005 | 2 | Product used for unknown indication |
| 125690051 | 12569005 | 3 | Product used for unknown indication |
| 125690051 | 12569005 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125690051 | 12569005 | OT |
| 125690051 | 12569005 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125690051 | 12569005 | Abdominal tenderness | |
| 125690051 | 12569005 | Acute kidney injury | |
| 125690051 | 12569005 | Circulatory collapse | |
| 125690051 | 12569005 | Mucosal dryness | |
| 125690051 | 12569005 | Viral diarrhoea |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125690051 | 12569005 | 1 | 20160521 | 0 | ||
| 125690051 | 12569005 | 2 | 20160521 | 0 | ||
| 125690051 | 12569005 | 3 | 20160521 | 0 |