Drug profile
The FDA adverse-event record for Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate
214 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate. See the species affected, top reactions, and outcomes below.
- 214
- adverse-event reports
- 1.4%
- death-coded share
- Dog
- most-reported species
- 66
- Deafness - top reaction
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate Adverse Event Insights
214 reports name Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate; 3 recorded a death outcome (1.4% of reported events, not a population-level mortality rate). Active ingredients: Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate. Administration routes: Auricular (Otic), Oral, Topical, Unknown.
By species: Dog (207 reports), Cat (5 reports), Human (1 reports). By breed: Retriever - Labrador (20), Crossbred Canine/dog (17), Dog (unknown) (15).
Leading clinical signs: Deafness (66), Loss of hearing (42), Lack of efficacy - NOS (21), Behavioural disorder NOS (19). Outcome, 213 coded reports: Recovered/Normal leads at 34.7%.
Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.
Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025
Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.