Fluoxetine — 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. Fluoxetine is a SSRI (canine separation anxiety).
Total reports
Fluoxetine: 2920
Reports by species (top entries)
- Dog 2512
- Cat 231
- Human 25
- Other 2
Top reported reactions (VEDDRA terms, top entries)
- Lack of efficacy - NOS 382
- Vomiting 354
- Anorexia 330
- Depression 225
- Diarrhoea 184
- Behavioural disorder NOS 147
- Accidental exposure 138
- Seizure NOS 138
- Lethargy (see also Central nervous system depression in Neurological) 133
- Decreased appetite 124
"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).