Ketoconazole — 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 2026-07-21. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. Ketoconazole is a veterinary active ingredient.
Total reports
Ketoconazole: 2585
Reports by species (top entries)
- Dog 2442
- Cat 115
- Human 24
- Ferret 1
Top reported reactions (VEDDRA terms, top entries)
- Lack of efficacy - NOS 359
- Vomiting 303
- Other abnormal test result NOS 205
- Lethargy (see also Central nervous system depression in 'Neurological') 204
- Diarrhoea 194
- Emesis 154
- Ataxia 139
- Anorexia 119
- Weight loss 116
- Loss of hearing 110
"Lack of efficacy" terms denote product-performance reports, not adverse reactions.
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-21.json (openFDA animalandveterinary/event.json, pulled 2026-07-21).