Drug profile

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

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

30
adverse-event reports
3.3%
death-coded share
Dog
most-reported species
4
Vomiting - 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.
30
Total Reports
1
Deaths Reported
3.3%
Death Rate

Active Ingredients

ChlorhexidineChlorhexidine + Ketoconazole + PhytosphingosineKetoconazolePhytosphingosine

Administration Routes

TopicalAuricular (Otic)UnknownCutaneous

Species Affected

Dog 28
Human 1
Cat 1

Most Affected Breeds

Crossbred Canine/dog 3
Havanese 2
Terrier - Jack Russell 2
Pug 2
Spaniel - Cocker American 2
Retriever - Labrador 2
Chihuahua 1
Dachshund - Miniature 1
Shih Tzu 1
Schnauzer - Miniature 1

Most Reported Reactions

Vomiting 4
Pruritus 4
Lack of efficacy - NOS 4
Emesis 3
Pustules 3
Application site erythema 3
Skin irritation 3
Ear discharge 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Not eating 2
Localised pain NOS (see other 'SOCs' for specific pain) 2
Behavioural disorder NOS 2

Outcome Breakdown

Outcome Unknown
11 (36.7%)
Recovered/Normal
11 (36.7%)
Ongoing
6 (20.0%)
Died
1 (3.3%)
Recovered with Sequela
1 (3.3%)

Chlorhexidine + Ketoconazole + Phytosphingosine Adverse Event Insights

30 reports name Chlorhexidine + Ketoconazole + Phytosphingosine; 1 recorded a death outcome (3.3% of reported events, not a population-level mortality rate). Active ingredients: Chlorhexidine, Chlorhexidine + Ketoconazole + Phytosphingosine, Ketoconazole, Phytosphingosine. Administration routes: Topical, Auricular (Otic), Unknown, Cutaneous.

By species: Dog (28 reports), Human (1 reports), Cat (1 reports). By breed: Crossbred Canine/dog (3), Havanese (2), Terrier - Jack Russell (2).

Leading clinical signs: Vomiting (4), Pruritus (4), Lack of efficacy - NOS (4), Emesis (3). Outcome, 30 coded reports: Outcome Unknown leads at 36.7%.

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.