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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114974325 | 11497432 | 5 | F | 2014 | 20160826 | 20150911 | 20160902 | EXP | US-DSJP-DSU-2015-127933 | DAIICHI | 0.00 | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114974325 | 11497432 | 1 | PS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 20 MG, PRN | U | 21286 | 20 | MG | TABLET | |||||||
| 114974325 | 11497432 | 2 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 20MG/12.5MG,QD | U | 0 | 1 | DF | FILM-COATED TABLET | QD | |||||
| 114974325 | 11497432 | 3 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | UNK | U | 0 | FILM-COATED TABLET | |||||||||
| 114974325 | 11497432 | 4 | SS | IMODIUM | LOPERAMIDE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 114974325 | 11497432 | 5 | C | MULTIVITAMINS | VITAMINS | 1 | 1 DF, QD | 0 | 1 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114974325 | 11497432 | 1 | Product used for unknown indication |
| 114974325 | 11497432 | 2 | Hypertension |
| 114974325 | 11497432 | 4 | Product used for unknown indication |
| 114974325 | 11497432 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114974325 | 11497432 | HO |
| 114974325 | 11497432 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114974325 | 11497432 | Abdominal discomfort | |
| 114974325 | 11497432 | Acute kidney injury | |
| 114974325 | 11497432 | Autoimmune hepatitis | |
| 114974325 | 11497432 | C-reactive protein increased | |
| 114974325 | 11497432 | Coeliac disease | |
| 114974325 | 11497432 | Hiatus hernia | |
| 114974325 | 11497432 | Liver function test increased | |
| 114974325 | 11497432 | Malabsorption |
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 |
|---|---|---|---|---|---|---|
| 114974325 | 11497432 | 2 | 201212 | 201401 | 0 | |
| 114974325 | 11497432 | 3 | 2012 | 0 |