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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124535062 | 12453506 | 2 | F | 2012 | 20151020 | 20160609 | 20160720 | PER | US-DSJP-DSU-2012-01585 | DAIICHI | 0.00 | M | Y | 110.20000 | KG | 20160718 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124535062 | 12453506 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/25MG, QD (QHS) | Y | 21532 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 124535062 | 12453506 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/12.5 MG, QD (QHS) | Y | 21532 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 124535062 | 12453506 | 3 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 40 MG, QD (QHS) | Y | 0 | 40 | MG | TABLET | QD | |||||
| 124535062 | 12453506 | 4 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 20 MG, QD (QHS) | Y | 0 | 20 | MG | TABLET | QD | |||||
| 124535062 | 12453506 | 5 | C | ZOCOR | SIMVASTATIN | 1 | UNK | 0 | |||||||||||
| 124535062 | 12453506 | 6 | C | PREDNISONE. | PREDNISONE | 1 | UNK | 0 | |||||||||||
| 124535062 | 12453506 | 7 | C | ANTIBIOTICS | UNSPECIFIED INGREDIENT | 1 | UNK | 0 | |||||||||||
| 124535062 | 12453506 | 8 | C | ZITHROMAX | AZITHROMYCIN DIHYDRATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124535062 | 12453506 | 1 | Hypertension |
| 124535062 | 12453506 | 3 | Hypertension |
| 124535062 | 12453506 | 5 | Blood cholesterol abnormal |
| 124535062 | 12453506 | 6 | Pulmonary congestion |
| 124535062 | 12453506 | 7 | Pulmonary congestion |
| 124535062 | 12453506 | 8 | Pulmonary congestion |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124535062 | 12453506 | Blood uric acid increased | |
| 124535062 | 12453506 | Dehydration | |
| 124535062 | 12453506 | Dizziness | |
| 124535062 | 12453506 | Fluid retention | |
| 124535062 | 12453506 | Gout | |
| 124535062 | 12453506 | Heart rate increased | |
| 124535062 | 12453506 | Hypotension | |
| 124535062 | 12453506 | Pain | |
| 124535062 | 12453506 | Respiratory tract congestion | |
| 124535062 | 12453506 | Weight decreased | |
| 124535062 | 12453506 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 124535062 | 12453506 | 1 | 201202 | 0 | ||
| 124535062 | 12453506 | 6 | 201202 | 201202 | 0 | |
| 124535062 | 12453506 | 7 | 201202 | 201202 | 0 | |
| 124535062 | 12453506 | 8 | 20120224 | 0 |