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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80493664 | 8049366 | 4 | F | 20110505 | 20160915 | 20110722 | 20160921 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2011-BP-17643BP | BOEHRINGER INGELHEIM | 75.00 | YR | M | Y | 93.90000 | KG | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 80493664 | 8049366 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | Y | NOT REPORTED | 22512 | CAPSULE | ||||||||
| 80493664 | 8049366 | 2 | SS | CELECOXIB. | CELECOXIB | 1 | Oral | Y | 0 | TABLET | |||||||||
| 80493664 | 8049366 | 3 | SS | SOTALOL HYDROCHLORIDE. | SOTALOL HYDROCHLORIDE | 1 | Oral | Y | 0 | ||||||||||
| 80493664 | 8049366 | 4 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Unknown | STRENGTH: 20 MG | 0 | TABLET | |||||||||
| 80493664 | 8049366 | 5 | C | ACETYLSALICYLIC ACID | ASPIRIN | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 7 | C | COENZYME Q10 | UBIDECARENONE | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 8 | C | FISH OIL | FISH OIL | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 9 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 10 | C | GEMFIBROZIL. | GEMFIBROZIL | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 11 | C | HUMULIN 70/30 | INSULIN HUMAN | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 12 | C | LOTREL | AMLODIPINE BESYLATEBENAZEPRIL HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 13 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 14 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 15 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 16 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 17 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | |||||||||||
| 80493664 | 8049366 | 18 | C | UNSPECIFIED PROBIOTIC | 2 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 80493664 | 8049366 | 1 | Hypertension |
| 80493664 | 8049366 | 2 | Osteoarthritis |
| 80493664 | 8049366 | 3 | Hypertension |
| 80493664 | 8049366 | 4 | Prophylaxis |
| 80493664 | 8049366 | 5 | Product used for unknown indication |
| 80493664 | 8049366 | 6 | Product used for unknown indication |
| 80493664 | 8049366 | 7 | Product used for unknown indication |
| 80493664 | 8049366 | 8 | Product used for unknown indication |
| 80493664 | 8049366 | 9 | Product used for unknown indication |
| 80493664 | 8049366 | 10 | Product used for unknown indication |
| 80493664 | 8049366 | 11 | Product used for unknown indication |
| 80493664 | 8049366 | 12 | Product used for unknown indication |
| 80493664 | 8049366 | 13 | Product used for unknown indication |
| 80493664 | 8049366 | 14 | Product used for unknown indication |
| 80493664 | 8049366 | 15 | Product used for unknown indication |
| 80493664 | 8049366 | 16 | Product used for unknown indication |
| 80493664 | 8049366 | 17 | Product used for unknown indication |
| 80493664 | 8049366 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 80493664 | 8049366 | HO |
| 80493664 | 8049366 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 80493664 | 8049366 | Acute kidney injury | |
| 80493664 | 8049366 | Atrial flutter | |
| 80493664 | 8049366 | Cardiac failure congestive | |
| 80493664 | 8049366 | Chronic kidney disease | |
| 80493664 | 8049366 | Ischaemic cardiomyopathy | |
| 80493664 | 8049366 | Tachycardia |
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 |
|---|---|---|---|---|---|---|
| 80493664 | 8049366 | 1 | 20110503 | 20110505 | 0 | |
| 80493664 | 8049366 | 2 | 20100414 | 20110505 | 0 | |
| 80493664 | 8049366 | 3 | 20110503 | 20110505 | 0 | |
| 80493664 | 8049366 | 4 | 20100414 | 20110505 | 0 | |
| 80493664 | 8049366 | 5 | 2008 | 0 | ||
| 80493664 | 8049366 | 6 | 20110503 | 0 | ||
| 80493664 | 8049366 | 7 | 201002 | 0 | ||
| 80493664 | 8049366 | 8 | 2008 | 0 | ||
| 80493664 | 8049366 | 9 | 2002 | 0 | ||
| 80493664 | 8049366 | 10 | 2002 | 0 | ||
| 80493664 | 8049366 | 11 | 2008 | 0 | ||
| 80493664 | 8049366 | 12 | 20100507 | 0 | ||
| 80493664 | 8049366 | 13 | 20110503 | 0 | ||
| 80493664 | 8049366 | 14 | 2002 | 0 | ||
| 80493664 | 8049366 | 15 | 2008 | 0 | ||
| 80493664 | 8049366 | 16 | 2004 | 0 | ||
| 80493664 | 8049366 | 17 | 201101 | 0 |