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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126124711 | 12612471 | 1 | I | 2015 | 20150908 | 20160801 | 20160801 | PER | US-PRINSTON PHARMACEUTICAL INC.-2015PRN00069 | PRINSTON PHARMACEUTICAL | 0.00 | F | Y | 85.71000 | KG | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126124711 | 12612471 | 1 | PS | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 100 MG, UNK | Y | Y | 1085B15002 | 91497 | 100 | MG | TABLET | ||||
| 126124711 | 12612471 | 2 | SS | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 100 MG, UNK | Y | Y | 91497 | 100 | MG | TABLET | |||||
| 126124711 | 12612471 | 3 | C | CARVEDILOL. | CARVEDILOL | 1 | 6.25 UNK, UNK | 0 | |||||||||||
| 126124711 | 12612471 | 4 | C | WARFARIN | WARFARIN | 1 | UNK | 0 | |||||||||||
| 126124711 | 12612471 | 5 | C | GLUCOPHAGE | METFORMIN HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126124711 | 12612471 | 6 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126124711 | 12612471 | 1 | Hypertension |
| 126124711 | 12612471 | 2 | Prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126124711 | 12612471 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126124711 | 12612471 | Atrial fibrillation | |
| 126124711 | 12612471 | Chest discomfort | |
| 126124711 | 12612471 | Chest pain | |
| 126124711 | 12612471 | Heart rate increased | |
| 126124711 | 12612471 | Product substitution issue |
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 |
|---|---|---|---|---|---|---|
| 126124711 | 12612471 | 1 | 20150802 | 201508 | 0 | |
| 126124711 | 12612471 | 2 | 201508 | 201508 | 0 |