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FDA ADE reports for Diphenhydramine

ade_diphenhydramine_adverse_events

ade en 2026-07-22

Diphenhydramine 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. Diphenhydramine is a active ingredient.

Total reports

Diphenhydramine: 2816

Reports by species (top entries)

  • Dog 2592
  • Cat 204
  • Human 16
  • Ferret 2
  • Horse 1

Top reported reactions (VEDDRA terms, top entries)

  • Vomiting 629
  • Emesis 342
  • Diarrhoea 335
  • Lethargy (see also Central nervous system depression in 'Neurological') 324
  • Lethargy (see also Central nervous system depression in Neurological) 275
  • Lack of efficacy - NOS 195
  • Not eating 195
  • Injection site swelling 170
  • Anaphylaxis 161
  • Emesis (multiple) 160

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b9.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).