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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779101 | 12677910 | 1 | I | 20151228 | 20160502 | 20160823 | 20160823 | PER | US-TARO-2016TAR00407 | TARO | 71.58 | YR | M | Y | 83.90000 | KG | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779101 | 12677910 | 1 | PS | WARFARIN SODIUM TABLETS USP 5MG | WARFARIN SODIUM | 1 | Oral | 5 MG, 5X/WEEK | 40301 | 5 | MG | TABLET | |||||||
| 126779101 | 12677910 | 2 | SS | WARFARIN SODIUM TABLETS USP 5MG | WARFARIN SODIUM | 1 | Oral | 2.5 MG, 2X/WEEK | 40301 | 2.5 | MG | TABLET | BIW | ||||||
| 126779101 | 12677910 | 3 | SS | WARFARIN SODIUM TABLETS USP 5MG | WARFARIN SODIUM | 1 | 2.5 MG, 1X/DAY | 40301 | 2.5 | MG | TABLET | QD | |||||||
| 126779101 | 12677910 | 4 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 20 MG, 2X/DAY | 0 | 20 | MG | TABLET | BID | |||||||
| 126779101 | 12677910 | 5 | C | ATENOLOL. | ATENOLOL | 1 | 25 MG, 2X/DAY | 0 | 25 | MG | TABLET | BID | |||||||
| 126779101 | 12677910 | 6 | C | ATENOLOL. | ATENOLOL | 1 | UNK | 0 | TABLET | ||||||||||
| 126779101 | 12677910 | 7 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | 5 MG, 1X/DAY | 0 | 5 | MG | QD | ||||||||
| 126779101 | 12677910 | 8 | C | QUINAPRIL HYDROCHLORIDE. | QUINAPRIL HYDROCHLORIDE | 1 | 20 MG, 1X/DAY | 0 | 20 | MG | QD | ||||||||
| 126779101 | 12677910 | 9 | C | ASPIRIN. | ASPIRIN | 1 | UNK | 0 | |||||||||||
| 126779101 | 12677910 | 10 | SS | UNKNOWN HEALING SPRAY | UNSPECIFIED INGREDIENT | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126779101 | 12677910 | 1 | Vascular graft |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126779101 | 12677910 | Constipation | |
| 126779101 | 12677910 | Dry skin | |
| 126779101 | 12677910 | Gastrointestinal pain | |
| 126779101 | 12677910 | Hypersensitivity | |
| 126779101 | 12677910 | Hypoaesthesia | |
| 126779101 | 12677910 | International normalised ratio increased | |
| 126779101 | 12677910 | Musculoskeletal pain | |
| 126779101 | 12677910 | Peripheral swelling | |
| 126779101 | 12677910 | Rash | |
| 126779101 | 12677910 | Skin exfoliation | |
| 126779101 | 12677910 | Skin fissures |
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 |
|---|---|---|---|---|---|---|
| 126779101 | 12677910 | 1 | 20151228 | 0 | ||
| 126779101 | 12677910 | 2 | 20151228 | 0 |