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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126594011 | 12659401 | 1 | I | 201606 | 20160805 | 20160817 | 20160817 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-51459BP | BOEHRINGER INGELHEIM | 76.90 | YR | M | Y | 0.00000 | 20160817 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126594011 | 12659401 | 1 | PS | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG | 20579 | .4 | MG | CAPSULE | QD | ||||||
| 126594011 | 12659401 | 2 | SS | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG | 20579 | .4 | MG | CAPSULE | QD | ||||||
| 126594011 | 12659401 | 3 | C | MULTAQ | DRONEDARONE | 1 | Oral | 800 MG | 0 | 400 | MG | BID | |||||||
| 126594011 | 12659401 | 4 | C | XARELTO | RIVAROXABAN | 1 | Oral | 20 MG | 0 | 20 | MG | QD | |||||||
| 126594011 | 12659401 | 5 | C | METOPROLOL. | METOPROLOL | 1 | Oral | STRENGTH:25MG, DOSE PER APPLICATION AND DAILY DOSE: 1/2 TABLET 2 TIMES PER DAY | 0 | BID | |||||||||
| 126594011 | 12659401 | 6 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 100 MG | 0 | 100 | MG | QD | |||||||
| 126594011 | 12659401 | 7 | C | atorvastatin | ATORVASTATIN | 1 | Oral | 40 MG | 0 | 40 | MG | QD | |||||||
| 126594011 | 12659401 | 8 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | BID | ||||||||
| 126594011 | 12659401 | 9 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | DAILY DOSE: 5MG (1 PILL) AS NEEDED | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126594011 | 12659401 | 1 | Prostatomegaly |
| 126594011 | 12659401 | 3 | Atrial fibrillation |
| 126594011 | 12659401 | 4 | Atrial fibrillation |
| 126594011 | 12659401 | 5 | Atrial fibrillation |
| 126594011 | 12659401 | 6 | Heart rate abnormal |
| 126594011 | 12659401 | 7 | Blood cholesterol increased |
| 126594011 | 12659401 | 8 | Gastrooesophageal reflux disease |
| 126594011 | 12659401 | 9 | Hypertension |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126594011 | 12659401 | Asthenia | |
| 126594011 | 12659401 | Blood pressure immeasurable | |
| 126594011 | 12659401 | Cardiac flutter | |
| 126594011 | 12659401 | Hyperhidrosis |
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 |
|---|---|---|---|---|---|---|
| 126594011 | 12659401 | 1 | 2015 | 2016 | 0 | |
| 126594011 | 12659401 | 2 | 201606 | 0 | ||
| 126594011 | 12659401 | 3 | 2014 | 0 | ||
| 126594011 | 12659401 | 4 | 2014 | 0 | ||
| 126594011 | 12659401 | 5 | 2011 | 0 | ||
| 126594011 | 12659401 | 7 | 2011 | 0 | ||
| 126594011 | 12659401 | 8 | 2011 | 0 | ||
| 126594011 | 12659401 | 9 | 201605 | 0 |