Miconazole — 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. Miconazole is a active ingredient.
Total reports
Miconazole: 1388
Reports by species (top entries)
- Dog 735
- Cat 46
- Human 8
- Rat 1
Top reported reactions (VEDDRA terms, top entries)
- Loss of hearing 300
- Difficulty of Use 220
- Dispenser, Abnormal 207
- 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 99
- Deafness 86
- Lack of efficacy - NOS 78
- Administration device NOS, abnormal 73
- Administration device NOS, malfunction 55
Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b10.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).