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FDA ADE reports for Amitriptyline

ade_amitriptyline_adverse_events

ade en 2026-07-22

Amitriptyline โ€” 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. Amitriptyline is a active ingredient.

Total reports

Amitriptyline: 187

Reports by species (top entries)

  • Dog 126
  • Cat 56
  • Human 4

Top reported reactions (VEDDRA terms, top entries)

  • Vomiting 47
  • Lethargy (see also Central nervous system depression in 'Neurological') 27
  • Emesis 19
  • Diarrhoea 14
  • Pruritus 13
  • Behavioural disorder NOS 12
  • Lack of efficacy - NOS 12
  • Anorexia 11
  • Seizure NOS 11
  • Elevated alanine aminotransferase (ALT) 10

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b18.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).