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FDA ADE reports for Sirolimus

ade_sirolimus_adverse_events

ade en 2026-07-22

Sirolimus 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. Sirolimus is a active ingredient.

Total reports

Sirolimus: 39

Reports by species (top entries)

  • Cat 38
  • Dog 1

Top reported reactions (VEDDRA terms, top entries)

  • Vomiting 12
  • Weight loss 9
  • Congestive heart failure 6
  • Elevated alanine aminotransferase (ALT) 6
  • Lethargy (see also Central nervous system depression in Neurological) 6
  • Abnormal radiograph finding 5
  • Abnormal ultrasound finding 5
  • Administration error NOS 5
  • Decreased appetite 5
  • Hypertension 5

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b25.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).