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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125586781 | 12558678 | 1 | I | 2014 | 20150828 | 20160715 | 20160715 | PER | US-ZYDUS-008973 | ZYDUS PHARM | 70.55 | YR | E | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125586781 | 12558678 | 1 | PS | WARFARIN | WARFARIN | 1 | Oral | UNKNOWN | 40663 | 6 | MG | TABLET | |||||||
| 125586781 | 12558678 | 2 | SS | WARFARIN | WARFARIN | 1 | Oral | U | UNKNOWN | 0 | TABLET | ||||||||
| 125586781 | 12558678 | 3 | SS | WARFARIN | WARFARIN | 1 | Oral | UNKNOWN | 0 | 20 | MG | TABLET | |||||||
| 125586781 | 12558678 | 4 | SS | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Oral | UNKNOWN | 0 | 75 | MG | TABLET | QD | ||||||
| 125586781 | 12558678 | 5 | C | METOPROLOL. | METOPROLOL | 1 | 0 | 200 | MG | QD | |||||||||
| 125586781 | 12558678 | 6 | C | HYDROCHLOROTHIAZIDE/VALSARTAN | 2 | 0 | TABLET | QD | |||||||||||
| 125586781 | 12558678 | 7 | C | MONTELUKAST/MONTELUKAST SODIUM | 2 | 0 | 10 | MG | TABLET | QD | |||||||||
| 125586781 | 12558678 | 8 | C | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | 0 | QD | |||||||||||
| 125586781 | 12558678 | 9 | C | HYDROXOCOBALAMIN | HYDROXOCOBALAMIN | 1 | 0 | SUBLINGUAL TABLET | |||||||||||
| 125586781 | 12558678 | 10 | C | CICLOSPORIN | CYCLOSPORINE | 1 | 0 | ||||||||||||
| 125586781 | 12558678 | 11 | C | VITAMIN D | CHOLECALCIFEROL | 1 | U | 0 | |||||||||||
| 125586781 | 12558678 | 12 | C | DENOSUMAB | DENOSUMAB | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125586781 | 12558678 | 1 | Atrial fibrillation |
| 125586781 | 12558678 | 2 | Atrial fibrillation |
| 125586781 | 12558678 | 3 | Atrial fibrillation |
| 125586781 | 12558678 | 4 | Atrial fibrillation |
| 125586781 | 12558678 | 5 | Hypertension |
| 125586781 | 12558678 | 6 | Hypertension |
| 125586781 | 12558678 | 7 | Chronic obstructive pulmonary disease |
| 125586781 | 12558678 | 8 | Chronic obstructive pulmonary disease |
| 125586781 | 12558678 | 9 | Supplementation therapy |
| 125586781 | 12558678 | 10 | Sjogren's syndrome |
| 125586781 | 12558678 | 11 | Osteoporosis |
| 125586781 | 12558678 | 12 | Osteoporosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125586781 | 12558678 | Bleeding time prolonged | Bleeding time prolonged |
| 125586781 | 12558678 | Contusion | Contusion |
| 125586781 | 12558678 | Insomnia | Insomnia |
| 125586781 | 12558678 | Muscle spasms | Muscle spasms |
| 125586781 | 12558678 | Pain in extremity | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 125586781 | 12558678 | 1 | 2015 | 0 | ||
| 125586781 | 12558678 | 2 | 2014 | 2015 | 0 | |
| 125586781 | 12558678 | 3 | 2015 | 0 | ||
| 125586781 | 12558678 | 4 | 2015 | 0 |