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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378311 | 12537831 | 1 | I | 200910 | 20150624 | 20160707 | 20160707 | EXP | US-DSJP-DSU-2015-120109 | DAIICHI | 57.90 | YR | F | Y | 45.35000 | KG | 20160707 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125378311 | 12537831 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 40/25 MG, ORAL, 1 TAB DAILY | Y | 21532 | FILM-COATED TABLET | |||||||||
| 125378311 | 12537831 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 20/12.5 MG, 1 BY MOUTH DAILY | Y | 21532 | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125378311 | 12537831 | 1 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125378311 | 12537831 | OT |
| 125378311 | 12537831 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125378311 | 12537831 | Acute kidney injury | |
| 125378311 | 12537831 | Anxiety | |
| 125378311 | 12537831 | Arthralgia | |
| 125378311 | 12537831 | Coeliac disease | |
| 125378311 | 12537831 | Depression | |
| 125378311 | 12537831 | Diverticulum | |
| 125378311 | 12537831 | Dizziness | |
| 125378311 | 12537831 | Gastrointestinal bacterial overgrowth | |
| 125378311 | 12537831 | Gastrooesophageal reflux disease | |
| 125378311 | 12537831 | Haemorrhoids | |
| 125378311 | 12537831 | Hepatic function abnormal | |
| 125378311 | 12537831 | Hiatus hernia | |
| 125378311 | 12537831 | Lactose intolerance | |
| 125378311 | 12537831 | Malabsorption | |
| 125378311 | 12537831 | Myalgia | |
| 125378311 | 12537831 | Pyrexia | |
| 125378311 | 12537831 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125378311 | 12537831 | 1 | 20090130 | 20101102 | 0 |