Drug profile

The FDA adverse-event record for Ketoconazole/Tromethamine/Disodium Edta Dihydrate

36 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.

36
adverse-event reports
2.8%
death-coded share
Dog
most-reported species
11
Lack of efficacy - NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
36
Total Reports
1
Deaths Reported
2.8%
Death Rate

Active Ingredients

Ketoconazole/Tromethamine/Disodium Edta Dihydrate

Administration Routes

UnknownTopical

Species Affected

Dog 32
Cat 4

Most Affected Breeds

Pug 4
Domestic Shorthair 4
Shepherd Dog - German 3
Shih Tzu 3
Retriever - Labrador 3
Spaniel - Cocker American 2
Dog (unknown) 2
Crossbred Canine/dog 2
Spaniel - King Charles Cavalier 2
Bulldog 2

Most Reported Reactions

Lack of efficacy - NOS 11
Ataxia 8
Head tilt - ear disorder 6
Nystagmus 6
Vomiting 5
Ear discharge 5
Emesis (multiple) 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Erythema (for urticaria see Immune SOC) 3
Ear pruritus 3
Head shake - ear disorder 3
Anorexia 3

Outcome Breakdown

Outcome Unknown
20 (55.6%)
Recovered/Normal
15 (41.7%)
Euthanized
1 (2.8%)

Ketoconazole/Tromethamine/Disodium Edta Dihydrate Adverse Event Insights

36 reports name Ketoconazole/Tromethamine/Disodium Edta Dihydrate; 1 recorded a death outcome (2.8% of reported events, not a population-level mortality rate). Active ingredient: Ketoconazole/Tromethamine/Disodium Edta Dihydrate. Administration routes: Unknown, Topical.

By species: Dog (32 reports), Cat (4 reports). By breed: Pug (4), Domestic Shorthair (4), Shepherd Dog - German (3).

Leading clinical signs: Lack of efficacy - NOS (11), Ataxia (8), Head tilt - ear disorder (6), Nystagmus (6). Outcome, 36 coded reports: Outcome Unknown leads at 55.6%.

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.