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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127375211 | 12737521 | 1 | I | 20150701 | 20160912 | 20160912 | PER | US-IMPAX LABORATORIES, INC-2015-IPXL-01368 | IMPAX | 0.00 | F | Y | 71.00000 | KG | 20160912 | CN | DK | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127375211 | 12737521 | 1 | PS | URSODIOL CAPSULES 300MG | URSODIOL | 1 | Unknown | APPROXIMATELY 15MG/KG/DAY | U | U | 77895 | CAPSULE | QID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127375211 | 12737521 | 1 | Cholestasis |
Outcome of event
no results found |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127375211 | 12737521 | Drug prescribing error | |
127375211 | 12737521 | Exposure during pregnancy | |
127375211 | 12737521 | Maternal exposure timing unspecified | |
127375211 | 12737521 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |