Drug profile

The FDA adverse-event record for Ketoconazole + Chlorhexidine + Acetic Acid

18 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ketoconazole + Chlorhexidine + Acetic Acid. See the species affected, top reactions, and outcomes below.

18
adverse-event reports
5.6%
death-coded share
Dog
most-reported species
6
Lack of efficacy - NOS - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
18
Total Reports
1
Deaths Reported
5.6%
Death Rate

Active Ingredients

Ketoconazole + Chlorhexidine + Acetic Acid

Administration Routes

Auricular (Otic)TopicalUnknownCutaneous

Species Affected

Dog 13
Cat 5

Most Affected Breeds

Retriever - Labrador 4
Domestic Shorthair 4
Shih Tzu 2
Pit Bull 1
Pug 1
Bulldog - American 1
Terrier (unspecified) 1
Terrier - Yorkshire 1
Bengal 1
Dachshund (unspecified) 1

Most Reported Reactions

Lack of efficacy - NOS 6
Vomiting 3
Emesis 2
Itching 2
Ear pain 2
Loss of hearing 2
Reddening of the skin 1
UNPALATABLE 1
Ear discharge 1
Otitis media 1
Ear irritation 1
CULTURE/TITER DATA ABNORMAL 1

Outcome Breakdown

Ongoing
8 (44.4%)
Outcome Unknown
5 (27.8%)
Recovered/Normal
3 (16.7%)
Euthanized
1 (5.6%)
Recovered with Sequela
1 (5.6%)

Ketoconazole + Chlorhexidine + Acetic Acid Adverse Event Insights

18 reports name Ketoconazole + Chlorhexidine + Acetic Acid; 1 recorded a death outcome (5.6% of reported events, not a population-level mortality rate). Active ingredient: Ketoconazole + Chlorhexidine + Acetic Acid. Administration routes: Auricular (Otic), Topical, Unknown, Cutaneous.

By species: Dog (13 reports), Cat (5 reports). By breed: Retriever - Labrador (4), Domestic Shorthair (4), Shih Tzu (2).

Leading clinical signs: Lack of efficacy - NOS (6), Vomiting (3), Emesis (2), Itching (2). Outcome, 18 coded reports: Ongoing leads at 44.4%.

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.