Drug profile

The FDA adverse-event record for Trizedta/Ketoconazole Ear Product

108 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Trizedta/Ketoconazole Ear Product. See the species affected, top reactions, and outcomes below.

108
adverse-event reports
1.9%
death-coded share
Dog
most-reported species
20
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.
108
Total Reports
2
Deaths Reported
1.9%
Death Rate

Active Ingredients

Trizedta/Ketoconazole Ear Product

Administration Routes

Auricular (Otic)UnknownTopicalOralOther

Species Affected

Dog 97
Cat 11

Most Affected Breeds

Retriever - Labrador 16
Shih Tzu 7
Boxer (German Boxer) 6
Spaniel - Cocker American 5
Shepherd Dog - German 4
Domestic Shorthair 4
Chihuahua 4
Retriever - Golden 4
Cat (unknown) 4
Terrier (unspecified) 4

Most Reported Reactions

Lack of efficacy - NOS 20
Ataxia 13
Vomiting 12
Loss of hearing 12
Lethargy (see also Central nervous system depression in 'Neurological') 10
Nystagmus 10
Head tilt - ear disorder 10
Head shake - ear disorder 9
Not eating 8
Other abnormal test result NOS 7
Ear infection NOS 6
Other ear disorder NOS 6

Outcome Breakdown

Outcome Unknown
45 (41.7%)
Ongoing
38 (35.2%)
Recovered/Normal
19 (17.6%)
Recovered with Sequela
4 (3.7%)
Euthanized
1 (0.9%)
Died
1 (0.9%)

Trizedta/Ketoconazole Ear Product Adverse Event Insights

108 reports name Trizedta/Ketoconazole Ear Product; 2 recorded a death outcome (1.9% of reported events, not a population-level mortality rate). Active ingredient: Trizedta/Ketoconazole Ear Product. Administration routes: Auricular (Otic), Unknown, Topical, Oral.

By species: Dog (97 reports), Cat (11 reports). By breed: Retriever - Labrador (16), Shih Tzu (7), Boxer (German Boxer) (6).

Leading clinical signs: Lack of efficacy - NOS (20), Ataxia (13), Vomiting (12), Loss of hearing (12). Outcome, 108 coded reports: Outcome Unknown leads at 41.7%.

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.