Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl

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91 adverse event reports submitted to the FDA

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
110.0%
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%)

Data Summary

Metric Value
Total adverse event reports 91
Reports involving death 1
Case-fatality rate (reported events) 110.0%
Distinct species in reports 3
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 3

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 91 adverse event reports referencing Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl, including 1 reports in which the animal died — a 110.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Chlorhexidine Gluconate, Ketoconazole, Phytosphingosine Salicyloyl. Reported administration routes include Topical, Auricular (Otic). These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl reports are Dog (76 reports), Cat (8 reports), Human (7 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (7), Crossbred Canine/dog (7), Unknown (7) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl are Application site hair coat discolouration (15), Application site erythema (14), Pruritus (7), Erythema (for urticaria see Immune SOC) (6). Of the 91 reports with a coded outcome, Recovered/Normal is the leading category at 58.2%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Chlorhexidine Gluconate + Ketoconazole + Phytosphingosine Salicyloyl.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial