Ursodiol — FDA Animal & Veterinary Adverse Event (ADE) Reports
Source: openFDA animalandveterinary/event.json, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-07-22. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. Ursodiol is a veterinary active ingredient.
Total reports
Ursodiol: 749
Reports by species (top entries)
- Dog 705
- Cat 43
- Other 1
Top reported reactions (VEDDRA terms, top entries)
- Vomiting 155
- Elevated alanine aminotransferase (ALT) 133
- Diarrhoea 116
- Lethargy (see also Central nervous system depression in 'Neurological') 99
- Elevated serum alkaline phosphatase (SAP) 88
- Death by euthanasia 85
- Decreased appetite 82
- Elevated total bilirubin 76
- Weight loss 74
- Lethargy (see also Central nervous system depression in Neurological) 69
"Lack of efficacy" terms denote product-performance reports, not adverse reactions.
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b6.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).