Mitotane — 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. Mitotane is a active ingredient.
Total reports
Mitotane: 46
Reports by species (top entries)
- Dog 45
- Other 1
Top reported reactions (VEDDRA terms, top entries)
- Hypoadrenocorticism 8
- Lethargy (see also Central nervous system depression in 'Neurological') 8
- Elevated serum alkaline phosphatase (SAP) 7
- Diarrhoea 6
- Elevated alanine aminotransferase (ALT) 6
- Weight loss 6
- Death by euthanasia 5
- Seizure NOS 5
- Abnormal adrenocorticotropic hormone (ACTH) stimulation test 4
- Decreased appetite 4
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b24.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).