Ketoconazole + Tris-Edta
19 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 | 19 |
| Reports involving death | 3 |
| Case-fatality rate (reported events) | 1580.0% |
| Distinct species in reports | 2 |
| Distinct breeds in reports | 13 |
| 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.
Ketoconazole + Tris-Edta Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 19 adverse event reports referencing Ketoconazole + Tris-Edta, including 3 reports in which the animal died — a 1580.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Ketoconazole, Ketoconazole + Tris-Edta, Tris-Edta. Reported administration routes include Unknown, Auricular (Otic). 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 Ketoconazole + Tris-Edta reports are Dog (17 reports), Cat (2 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (3), Poodle (unspecified) (3), Poodle - Toy (2) 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 Ketoconazole + Tris-Edta are Lack of efficacy (fungi) - NOS (5), Head tilt - ear disorder (4), Ear canal erythema (3), Tense abdomen (3). Of the 19 reports with a coded outcome, Outcome Unknown is the leading category at 31.6%. 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 Ketoconazole + Tris-Edta.
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.