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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117162303 | 11716230 | 3 | F | 2013 | 20150806 | 20151109 | 20160720 | PER | US-DSJP-DSU-2015-124887 | DAIICHI | 0.00 | F | Y | 76.64000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117162303 | 11716230 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 20/12.5 MG, QD | Y | 170219 | 21532 | 1 | DF | FILM-COATED TABLET | QD | ||||
| 117162303 | 11716230 | 2 | SS | AZOR | AMLODIPINE BESYLATEOLMESARTAN MEDOXOMIL | 1 | 20/5 MG, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117162303 | 11716230 | 1 | Hypertension |
| 117162303 | 11716230 | 2 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117162303 | 11716230 | Blood pressure increased | |
| 117162303 | 11716230 | Dizziness | |
| 117162303 | 11716230 | Ear discomfort | |
| 117162303 | 11716230 | Eye pain | |
| 117162303 | 11716230 | Headache | |
| 117162303 | 11716230 | Muscle spasms | |
| 117162303 | 11716230 | Paraesthesia oral | |
| 117162303 | 11716230 | Peripheral swelling | |
| 117162303 | 11716230 | Pruritus | |
| 117162303 | 11716230 | Rash | |
| 117162303 | 11716230 | Somnolence | |
| 117162303 | 11716230 | Thirst | |
| 117162303 | 11716230 | Vision blurred | |
| 117162303 | 11716230 | 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 |
|---|---|---|---|---|---|---|
| 117162303 | 11716230 | 1 | 20130224 | 20130313 | 0 | |
| 117162303 | 11716230 | 2 | 2015 | 0 |