Miconazole + Polymyxin B + Prednisolone
803 adverse event reports submitted to the FDA
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Data Summary
| Metric | Value |
|---|---|
| Total adverse event reports | 803 |
| Reports involving death | 10 |
| Case-fatality rate (reported events) | 120.0% |
| Distinct species in reports | 4 |
| Distinct breeds in reports | 20 |
| Distinct reactions reported | 20 |
| Active ingredients on file | 3 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.
Miconazole + Polymyxin B + Prednisolone Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 803 adverse event reports referencing Miconazole + Polymyxin B + Prednisolone, including 10 reports in which the animal died — a 120.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Miconazole, Polymyxin B, Prednisolone. Reported administration routes include Auricular (Otic), Unknown, Topical, Oral. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.
The species most frequently named in Miconazole + Polymyxin B + Prednisolone reports are Dog (719 reports), Unknown (55 reports), Cat (25 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (67), Unknown (60), Terrier - Yorkshire (46) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.
The most commonly reported clinical signs associated with Miconazole + Polymyxin B + Prednisolone are Loss of hearing (193), Deafness (155), Lack of efficacy - NOS (100), Impaired hearing (79). Of the 747 reports with a coded outcome, Ongoing is the leading category at 44.6%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Miconazole + Polymyxin B + Prednisolone.
Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates
Read our methodology — how this data is sourced, computed, and verified.