Drug profile

The FDA adverse-event record for Chlorhexidine Gluconate + Ketoconazole

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

26
adverse-event reports
3.8%
death-coded share
Dog
most-reported species
5
Application site erythema - 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.
26
Total Reports
1
Deaths Reported
3.8%
Death Rate

Active Ingredients

Chlorhexidine GluconateChlorhexidine Gluconate + KetoconazoleKetoconazole

Administration Routes

TopicalUnknownAuricular (Otic)

Species Affected

Dog 24
Human 2

Most Affected Breeds

Terrier - Yorkshire 3
Pit Bull 3
Bulldog - French 3
Unknown 2
Siberian Husky 1
Schnauzer (unspecified) 1
Terrier - West Highland White 1
Spaniel - Cocker American 1
Boxer (German Boxer) 1
Schnauzer - Miniature 1

Most Reported Reactions

Application site erythema 5
Application site pain 3
Hives (see also 'Skin') 2
Urticaria 2
Application site reddening 2
Corneal ulcer 2
Eye disorder NOS (for Photophobia see neurological) 2
Lack of efficacy (fungi) - NOS 2
Lack of efficacy - NOS 1
Skin irritation 1
Closed eyelid 1
Application site inflammation 1

Outcome Breakdown

Outcome Unknown
9 (34.6%)
Recovered/Normal
8 (30.8%)
Ongoing
8 (30.8%)
Euthanized
1 (3.8%)

Chlorhexidine Gluconate + Ketoconazole Adverse Event Insights

26 reports name Chlorhexidine Gluconate + Ketoconazole; 1 recorded a death outcome (3.8% of reported events, not a population-level mortality rate). Active ingredients: Chlorhexidine Gluconate, Chlorhexidine Gluconate + Ketoconazole, Ketoconazole. Administration routes: Topical, Unknown, Auricular (Otic).

By species: Dog (24 reports), Human (2 reports). By breed: Terrier - Yorkshire (3), Pit Bull (3), Bulldog - French (3).

Leading clinical signs: Application site erythema (5), Application site pain (3), Hives (see also 'Skin') (2), Urticaria (2). Outcome, 26 coded reports: Outcome Unknown leads at 34.6%.

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.