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FDA ADE reports for Nystatin

ade_nystatin_adverse_events

ade en 2026-07-22

Nystatin 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. Nystatin is a active ingredient.

Total reports

Nystatin: 371

Reports by species (top entries)

  • Dog 298
  • Cat 50
  • Human 6
  • Other 2
  • Horse 1

Top reported reactions (VEDDRA terms, top entries)

  • Deafness 112
  • Loss of hearing 61
  • Vomiting 28
  • Lack of efficacy - NOS 26
  • Accidental exposure 23
  • Lethargy (see also Central nervous system depression in Neurological) 22
  • Diarrhoea 19
  • Medication error NOS 16
  • Temporary deafness 13
  • Incorrect route of drug administration 11

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b16.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).