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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126996901 | 12699690 | 1 | I | 2009 | 20150902 | 20160830 | 20160830 | PER | US-AMNEAL PHARMACEUTICALS-2015AMN00005 | AMNEAL | 0.00 | M | Y | 95.24000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126996901 | 12699690 | 1 | PS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | 1 TABLETS, 1X/DAY | N | AR5114053 (POSSIBLE) | 91426 | 1 | DF | TABLET | QD | ||||
| 126996901 | 12699690 | 2 | SS | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | N | 91426 | TABLET | ||||||||||
| 126996901 | 12699690 | 3 | C | Levothyroxine 25 mcg | 2 | Oral | 0 | ||||||||||||
| 126996901 | 12699690 | 4 | C | Atenolol 25 mg | ATENOLOL | 1 | Oral | 1 TABLETS, UNK | 0 | 1 | DF | ||||||||
| 126996901 | 12699690 | 5 | C | COUMADIN | WARFARIN SODIUM | 1 | Oral | 5 MG, UNK | 0 | 5 | MG | ||||||||
| 126996901 | 12699690 | 6 | C | Tamsulosin 0.4 mg | TAMSULOSIN | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126996901 | 12699690 | 1 | Peripheral swelling |
| 126996901 | 12699690 | 2 | Blood pressure increased |
| 126996901 | 12699690 | 4 | Cardiac fibrillation |
| 126996901 | 12699690 | 5 | Anticoagulant therapy |
| 126996901 | 12699690 | 6 | Prostatomegaly |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126996901 | 12699690 | Breast mass | |
| 126996901 | 12699690 | Breast pain | |
| 126996901 | 12699690 | Gynaecomastia |
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 |
|---|---|---|---|---|---|---|
| 126996901 | 12699690 | 1 | 2009 | 201505 | 0 |