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FDA ADE reports for Fluoxetine (SSRI (canine separation anxiety)) — total reports, species & reaction breakdown

ade_fluoxetine_adverse_events

ade 192 tok en 2026-07-21

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).

Sources

  • openFDA animalandveterinary/event.json (FDA CVM adverse event reports), pulled 2026-07-21