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FDA ADE reports for Gentamicin

ade_gentamicin_sulfate_adverse_events

ade en 2026-07-22

Gentamicin 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. Gentamicin is a active ingredient.

Total reports

Gentamicin: 1378

Reports by species (top entries)

  • Dog 577
  • Horse 76
  • Cat 30
  • Cattle 4
  • Human 4
  • Pig 4

Top reported reactions (VEDDRA terms, top entries)

  • Loss of hearing 256
  • Difficulty of Use 223
  • Dispenser, Abnormal 217
  • Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') 160
  • Administration device NOS, priming issue 130
  • Product Defect, General 106
  • Administration device NOS, abnormal 75
  • Administration device NOS, malfunction 69
  • Lack of efficacy - NOS 69
  • Containers, Damaged 51

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b10.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).