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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127081141 | 12708114 | 1 | I | 20160823 | 20160901 | 20160901 | EXP | US-IMPAX LABORATORIES, INC-2016-IPXL-00949 | IMPAX | PHEMISTER J, POURMORTEZA M, BRAHMBHATT P, REDDY C, YOUNG M.. HYPERSENSITIVITY REACTION TO URSODIOL RESULTING IN CARDIAC ARRHYTHMIA.. AM. J. GASTROENTEROL.. 2015;110 (SUPPL.1):391-2 | 29.00 | YR | M | Y | 0.00000 | 20160901 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127081141 | 12708114 | 1 | PS | URSODIOL. | URSODIOL | 1 | Unknown | ONE DOSE, UNK | U | 77895 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127081141 | 12708114 | 1 | Transaminases increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127081141 | 12708114 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127081141 | 12708114 | Angioedema | |
| 127081141 | 12708114 | Atrial fibrillation | |
| 127081141 | 12708114 | Hypersensitivity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |