Tacrolimus — 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. Tacrolimus is a active ingredient.
Total reports
Tacrolimus: 235
Reports by species (top entries)
- Dog 231
- Cat 2
- 1
- Human 1
Top reported reactions (VEDDRA terms, top entries)
- Vomiting 34
- Diarrhoea 24
- Lack of efficacy - NOS 21
- Lethargy (see also Central nervous system depression in Neurological) 21
- Weight loss 21
- Death by euthanasia 18
- Lethargy (see also Central nervous system depression in 'Neurological') 18
- Polyuria 16
- Behavioural disorder NOS 15
- Dry eye 15
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b17.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).