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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779111 | 12677911 | 1 | I | 201604 | 20160504 | 20160823 | 20160823 | PER | US-TARO-2016TAR00413 | TARO | 66.59 | YR | F | Y | 77.98000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126779111 | 12677911 | 1 | PS | WARFARIN SODIUM TABLETS USP 5MG | WARFARIN SODIUM | 1 | Oral | 5 MG, 2X/WEEK | 40301 | 5 | MG | TABLET | BIW | ||||||
| 126779111 | 12677911 | 2 | SS | WARFARIN SODIUM TABLETS USP 5MG | WARFARIN SODIUM | 1 | Oral | 7.5 MG, 5X/WEEK | 40301 | 7.5 | MG | TABLET | |||||||
| 126779111 | 12677911 | 3 | C | ASTEPRO | AZELASTINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 4 | C | NASACORT | TRIAMCINOLONE ACETONIDE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 5 | C | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 7 | C | METOPROLOL TARTRATE. | METOPROLOL TARTRATE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 8 | C | METHOTREXATE. | METHOTREXATE | 1 | UNK, 1X/WEEK | 0 | INJECTION | /wk | |||||||||
| 126779111 | 12677911 | 9 | C | MULTAQ | DRONEDARONE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 10 | C | ORENCIA | ABATACEPT | 1 | 0 | INFUSION | |||||||||||
| 126779111 | 12677911 | 11 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 12 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 13 | C | ATROVENT | IPRATROPIUM BROMIDE | 1 | UNK, AS NEEDED | 0 | |||||||||||
| 126779111 | 12677911 | 14 | C | ZANTAC | RANITIDINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 126779111 | 12677911 | 15 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126779111 | 12677911 | 1 | Atrial fibrillation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126779111 | 12677911 | Hypertrophy of tongue papillae | |
| 126779111 | 12677911 | International normalised ratio fluctuation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |