Drug profile

The FDA adverse-event record for Chloroxylenol + Ketoconazole

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

12
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
3
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.
12
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Chloroxylenol + Ketoconazole

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 12

Most Affected Breeds

Spaniel - Cocker American 3
Retriever - Labrador 2
Pit Bull 2
Beagle 1
Poodle - Standard 1
Mastiff 1
Spitz - German Pomeranian 1
Retriever - Golden 1

Most Reported Reactions

Lack of efficacy - NOS 3
Ear infection NOS 2
Loss of hearing 2
Otorrhoea 1
Lethargy (see also Central nervous system depression in 'Neurological') 1
Decreased appetite 1
Increased borborygmus 1
Lack of efficacy (tapeworm) 1
Lack of efficacy 1
Application site bleeding 1
Crying 1
Behavioural disorder NOS 1

Outcome Breakdown

Outcome Unknown
6 (50.0%)
Ongoing
5 (41.7%)
Recovered/Normal
1 (8.3%)

Chloroxylenol + Ketoconazole Adverse Event Insights

12 reports name Chloroxylenol + Ketoconazole; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Chloroxylenol + Ketoconazole. Administration routes: Auricular (Otic), Unknown.

By species: Dog (12 reports). By breed: Spaniel - Cocker American (3), Retriever - Labrador (2), Pit Bull (2).

Leading clinical signs: Lack of efficacy - NOS (3), Ear infection NOS (2), Loss of hearing (2), Otorrhoea (1). Outcome, 12 coded reports: Outcome Unknown leads at 50.0%.

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.