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FDA ADE reports for Hydroxyzine

ade_hydroxyzine_adverse_events

ade en 2026-07-22

Hydroxyzine — 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. Hydroxyzine is a active ingredient.

Total reports

Hydroxyzine: 1005

Reports by species (top entries)

  • Dog 972
  • Cat 16
  • Human 9
  • Horse 3

Top reported reactions (VEDDRA terms, top entries)

  • Emesis 213
  • Vomiting 169
  • Lethargy (see also Central nervous system depression in 'Neurological') 128
  • Diarrhoea 84
  • Other abnormal test result NOS 78
  • Lack of efficacy - NOS 74
  • Elevated serum alkaline phosphatase (SAP) 45
  • Behavioural disorder NOS 43
  • Elevated alanine aminotransferase (ALT) 43
  • Seizure NOS 42

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b11.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).

Sources

FDA ADE reports for Hydroxyzine (active ingredient) — total reports, species & reaction breakdown
Source document: FDA FAERS / openFDA Animal & Veterinary Event Reports
US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database)retrieved 2026-07-22

Verification file: pdf-raw/ade/ade_active_ingredients_2026-07-22_b11.json

Link points to the issuing authority's site; a direct document link is still being verified.