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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402881 | 12540288 | 1 | I | 2014 | 20150814 | 20160708 | 20160708 | PER | US-DSJP-DSU-2015-125584 | DAIICHI | 0.00 | F | Y | 74.38000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125402881 | 12540288 | 1 | PS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | ??/12.5 MG, QD | Y | 21532 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 125402881 | 12540288 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 40/25 MG, QD | Y | 21532 | 1 | DF | FILM-COATED TABLET | QD | ||||||
| 125402881 | 12540288 | 3 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 1/2 (40/25 MG) , QD | Y | 21532 | .5 | DF | FILM-COATED TABLET | QD | ||||||
| 125402881 | 12540288 | 4 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | UNK | 0 | |||||||||||
| 125402881 | 12540288 | 5 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 125402881 | 12540288 | 6 | C | UNKNOWN SLEEPING PILL | UNSPECIFIED INGREDIENT | 1 | UNK, PRN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125402881 | 12540288 | 1 | Hypertension |
| 125402881 | 12540288 | 4 | Blood cholesterol increased |
| 125402881 | 12540288 | 5 | Gastrooesophageal reflux disease |
| 125402881 | 12540288 | 6 | Insomnia |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125402881 | 12540288 | Abdominal pain upper | |
| 125402881 | 12540288 | Arthralgia | |
| 125402881 | 12540288 | Blood pressure decreased | |
| 125402881 | 12540288 | Blood pressure increased | |
| 125402881 | 12540288 | Constipation | |
| 125402881 | 12540288 | Depression | |
| 125402881 | 12540288 | Diarrhoea | |
| 125402881 | 12540288 | Dizziness | |
| 125402881 | 12540288 | Memory impairment | |
| 125402881 | 12540288 | Myalgia | |
| 125402881 | 12540288 | Nausea | |
| 125402881 | 12540288 | Off label use | |
| 125402881 | 12540288 | Therapeutic response decreased |
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 |
|---|---|---|---|---|---|---|
| 125402881 | 12540288 | 1 | 2013 | 2014 | 0 | |
| 125402881 | 12540288 | 2 | 2014 | 2014 | 0 | |
| 125402881 | 12540288 | 3 | 2014 | 20150808 | 0 | |
| 125402881 | 12540288 | 4 | 20150710 | 0 |