Drug profile
The FDA adverse-event record for Ketoconazole + Tromethamine + Disodium Edta Dihydrate
76 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ketoconazole + Tromethamine + Disodium Edta Dihydrate. See the species affected, top reactions, and outcomes below.
- 76
- adverse-event reports
- 1.3%
- death-coded share
- Dog
- most-reported species
- 17
- Lack of efficacy - NOS - top reaction
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Ketoconazole + Tromethamine + Disodium Edta Dihydrate Adverse Event Insights
76 reports name Ketoconazole + Tromethamine + Disodium Edta Dihydrate; 1 recorded a death outcome (1.3% of reported events, not a population-level mortality rate). Active ingredient: Ketoconazole + Tromethamine + Disodium Edta Dihydrate. Administration routes: Auricular (Otic), Unknown, Other.
By species: Dog (75 reports), Unknown (1 reports). By breed: Terrier - Yorkshire (7), Retriever - Labrador (6), Shepherd Dog - Australian (5).
Leading clinical signs: Lack of efficacy - NOS (17), Vomiting (10), Head tilt - ear disorder (9), Ocular discharge (9). Outcome, 75 coded reports: Outcome Unknown leads at 50.7%.
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.