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FDA ADE reports for Itraconazole — total reports, species & reaction breakdown

ade_itraconazole_adverse_events

ade 200 tok en 2026-07-21

Itraconazole — 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. Itraconazole is a veterinary active ingredient.

Total reports

Itraconazole: 580

Reports by species (top entries)

  • Cat 436
  • Dog 46
  • Other Birds 3
  • Human 2
  • Goat 1
  • Monkey 1

Top reported reactions (VEDDRA terms, top entries)

  • Lack of efficacy - NOS 102
  • Vomiting 88
  • Lethargy (see also Central nervous system depression in 'Neurological') 64
  • Elevated alanine aminotransferase (ALT) 60
  • Not eating 60
  • Weight loss 58
  • Decreased appetite 47
  • Elevated total bilirubin 45
  • Elevated liver enzymes 41
  • Diarrhoea 37

"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