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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126996971 | 12699697 | 1 | I | 20160512 | 20160830 | 20160830 | PER | US-AMNEAL PHARMACEUTICALS-2016AMN00242 | AMNEAL | 0.00 | F | Y | 130.61000 | KG | 20160830 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126996971 | 12699697 | 1 | PS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 25 MG, 1X/DAY | Y | AR151017 | 91426 | 25 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126996971 | 12699697 | 1 | Blood pressure measurement |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126996971 | 12699697 | Activities of daily living impaired | |
| 126996971 | 12699697 | Dizziness | |
| 126996971 | 12699697 | Gait disturbance | |
| 126996971 | 12699697 | Product substitution issue | |
| 126996971 | 12699697 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |