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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119960393 | 11996039 | 3 | F | 2013 | 20160824 | 20160203 | 20160831 | EXP | US-DSJP-DSU-2015-131868 | DAIICHI | 0.00 | Y | 0.00000 | 20160831 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119960393 | 11996039 | 1 | PS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | 40 MG, UNK | U | 21286 | 40 | MG | TABLET | |||||||
| 119960393 | 11996039 | 2 | SS | BENICAR | OLMESARTAN MEDOXOMIL | 1 | Oral | 40 MG, QD | U | 21286 | 40 | MG | TABLET | QD | |||||
| 119960393 | 11996039 | 3 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 20/12.5 MG, ONE WEEK | 1777 | DF | U | 0 | 1 | DF | FILM-COATED TABLET | |||||
| 119960393 | 11996039 | 4 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/25 MG, QD | 1777 | DF | U | 0 | 1 | DF | FILM-COATED TABLET | QD | |||
| 119960393 | 11996039 | 5 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | 20/12.5 MG, QD | 1777 | DF | U | 0 | 1 | DF | FILM-COATED TABLET | QD | ||||
| 119960393 | 11996039 | 6 | SS | BENICAR HCT | HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL | 1 | Oral | 40/25 MG, QD | 1777 | DF | U | 0 | 1 | DF | FILM-COATED TABLET | QD | |||
| 119960393 | 11996039 | 7 | C | CLOTRIM | 2 | UNK | 0 | ||||||||||||
| 119960393 | 11996039 | 8 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Oral | 20 MG, QD | 0 | 20 | MG | TABLET | QD | ||||||
| 119960393 | 11996039 | 9 | C | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 7.5MG/325MG UNK | 0 | 1 | DF | |||||||||
| 119960393 | 11996039 | 10 | C | CELEBREX | CELECOXIB | 1 | 200 MG, BID | 0 | 200 | MG | BID | ||||||||
| 119960393 | 11996039 | 11 | C | CARVEDIOL | CARVEDILOL | 1 | 12.5 MG, UNK | 0 | 12.5 | MG | TABLET | QD | |||||||
| 119960393 | 11996039 | 12 | C | CARVEDIOL | CARVEDILOL | 1 | Oral | 12.5 MG, BID | 0 | 12.5 | MG | TABLET | BID | ||||||
| 119960393 | 11996039 | 13 | C | METHOCARBAMOL. | METHOCARBAMOL | 1 | UNK | 0 | |||||||||||
| 119960393 | 11996039 | 14 | C | TRAMADOL HCL | TRAMADOL HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 119960393 | 11996039 | 15 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | 40 MG, BID | 0 | 40 | MG | BID | ||||||||
| 119960393 | 11996039 | 16 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | UNK | 0 | |||||||||||
| 119960393 | 11996039 | 17 | C | VIMOVO | ESOMEPRAZOLE MAGNESIUMNAPROXEN | 1 | 500/20 MG, BID | 0 | 1 | DF | BID | ||||||||
| 119960393 | 11996039 | 18 | C | CARAFATE | SUCRALFATE | 1 | 10 ML 2 TEASPOON/DAY BEFORE MEAL, UNK | 0 | 10 | ML | |||||||||
| 119960393 | 11996039 | 19 | C | HYOSCYAMINE. | HYOSCYAMINE | 1 | UNK | 0 | |||||||||||
| 119960393 | 11996039 | 20 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | TABLET | QD | ||||||
| 119960393 | 11996039 | 21 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Oral | 10 MG, QD | 0 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119960393 | 11996039 | 1 | Hypertension |
| 119960393 | 11996039 | 3 | Hypertension |
| 119960393 | 11996039 | 7 | Rash |
| 119960393 | 11996039 | 8 | Blood cholesterol increased |
| 119960393 | 11996039 | 9 | Product used for unknown indication |
| 119960393 | 11996039 | 10 | Product used for unknown indication |
| 119960393 | 11996039 | 11 | Hypertension |
| 119960393 | 11996039 | 13 | Product used for unknown indication |
| 119960393 | 11996039 | 14 | Product used for unknown indication |
| 119960393 | 11996039 | 15 | Gastrooesophageal reflux disease |
| 119960393 | 11996039 | 16 | Product used for unknown indication |
| 119960393 | 11996039 | 17 | Gastric ulcer |
| 119960393 | 11996039 | 18 | Duodenal ulcer |
| 119960393 | 11996039 | 19 | Product used for unknown indication |
| 119960393 | 11996039 | 20 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119960393 | 11996039 | OT |
| 119960393 | 11996039 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119960393 | 11996039 | Acute kidney injury | |
| 119960393 | 11996039 | Barrett's oesophagus | |
| 119960393 | 11996039 | Cholecystitis | |
| 119960393 | 11996039 | Constipation | |
| 119960393 | 11996039 | Drug ineffective | |
| 119960393 | 11996039 | Helicobacter test positive | |
| 119960393 | 11996039 | 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 |
|---|---|---|---|---|---|---|
| 119960393 | 11996039 | 1 | 20120813 | 20121219 | 0 | |
| 119960393 | 11996039 | 2 | 201404 | 0 | ||
| 119960393 | 11996039 | 3 | 20060626 | 0 | ||
| 119960393 | 11996039 | 4 | 20091111 | 20120813 | 0 | |
| 119960393 | 11996039 | 5 | 20100818 | 0 | ||
| 119960393 | 11996039 | 6 | 20121219 | 20150409 | 0 | |
| 119960393 | 11996039 | 15 | 201412 | 0 | ||
| 119960393 | 11996039 | 17 | 201412 | 0 | ||
| 119960393 | 11996039 | 20 | 201504 | 0 | ||
| 119960393 | 11996039 | 21 | 201504 | 0 |