Drug profile

The FDA adverse-event record for Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl

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

91
adverse-event reports
1.1%
death-coded share
Dog
most-reported species
15
Application site hair coat discolouration - 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.
91
Total Reports
1
Deaths Reported
1.1%
Death Rate

Active Ingredients

Chlorhexidine GluconateKetoconazolePhytosphingosine Salicyloyl

Administration Routes

TopicalAuricular (Otic)

Species Affected

Dog 76
Cat 8
Human 7

Most Affected Breeds

Domestic Shorthair 7
Crossbred Canine/dog 7
Unknown 7
Shih Tzu 7
Mixed (Dog) 7
Dog (unknown) 6
Pit Bull 5
Terrier - West Highland White 3
Retriever - Labrador 3
Retriever - Golden 3

Most Reported Reactions

Application site hair coat discolouration 15
Application site erythema 14
Pruritus 7
Erythema (for urticaria see Immune SOC) 6
Color, Abnormal 6
Skin inflammation NOS 5
Application site irritation 4
Application site pruritus 4
Hypersalivation 4
Vomiting 3
Application site reddening 3
Emesis (multiple) 3

Outcome Breakdown

Recovered/Normal
53 (58.2%)
Ongoing
26 (28.6%)
Outcome Unknown
10 (11.0%)
Recovered with Sequela
1 (1.1%)
Died
1 (1.1%)

Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl Adverse Event Insights

91 reports name Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl; 1 recorded a death outcome (1.1% of reported events, not a population-level mortality rate). Active ingredients: Chlorhexidine Gluconate, Ketoconazole, Phytosphingosine Salicyloyl. Administration routes: Topical, Auricular (Otic).

By species: Dog (76 reports), Cat (8 reports), Human (7 reports). By breed: Domestic Shorthair (7), Crossbred Canine/dog (7), Unknown (7).

Leading clinical signs: Application site hair coat discolouration (15), Application site erythema (14), Pruritus (7), Erythema (for urticaria see Immune SOC) (6). Outcome, 91 coded reports: Recovered/Normal leads at 58.2%.

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.