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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378641 | 12537864 | 1 | I | 2005 | 20150629 | 20160707 | 20160707 | EXP | US-DSJP-DSU-2015-120649 | DAIICHI | 36.55 | YR | M | Y | 117.91000 | KG | 20160707 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378641 | 12537864 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 40/25 MG, QD | N | 21532 | 40 | MG | FILM-COATED TABLET | QD | ||||||
| 125378641 | 12537864 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 20/12.5 MG, QD | N | 21532 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 125378641 | 12537864 | 3 | C | LABETALOL | LABETALOLLABETALOL HYDROCHLORIDE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125378641 | 12537864 | 1 | Hypertension |
| 125378641 | 12537864 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125378641 | 12537864 | HO |
| 125378641 | 12537864 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125378641 | 12537864 | Blood urine present | |
| 125378641 | 12537864 | Hydronephrosis | |
| 125378641 | 12537864 | Irritable bowel syndrome | |
| 125378641 | 12537864 | Malabsorption | |
| 125378641 | 12537864 | Micturition urgency | |
| 125378641 | 12537864 | Nephrolithiasis | |
| 125378641 | 12537864 | Renal colic | |
| 125378641 | 12537864 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 125378641 | 12537864 | 1 | 2005 | 20130802 | 0 | |
| 125378641 | 12537864 | 3 | 20131002 | 20141017 | 0 |