Misoprostol — 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. Misoprostol is a active ingredient.
Total reports
Misoprostol: 156
Reports by species (top entries)
- Horse 91
- Dog 62
- Cat 2
- Donkey 1
Top reported reactions (VEDDRA terms, top entries)
- Lack of efficacy - NOS 67
- INEFFECTIVE, GASTRIC ULCER(S) 26
- Vomiting 24
- Death by euthanasia 20
- Lethargy (see also Central nervous system depression in 'Neurological') 20
- Anorexia 17
- Elevated alanine aminotransferase (ALT) 17
- Diarrhoea 16
- Elevated serum alkaline phosphatase (SAP) 16
- Anaemia NOS 15
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b19.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).