Melatonin — 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. Melatonin is a active ingredient.
Total reports
Melatonin: 263
Reports by species (top entries)
- Dog 256
- Cat 3
- Human 2
- Pig 1
Top reported reactions (VEDDRA terms, top entries)
- Diarrhoea 40
- Vomiting 38
- Lethargy (see also Central nervous system depression in 'Neurological') 28
- Decreased appetite 25
- Other abnormal test result NOS 22
- Elevated alanine aminotransferase (ALT) 21
- Polydipsia 21
- Weight loss 21
- Death by euthanasia 20
- Anorexia 19
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b17.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).