Drug profile

The FDA adverse-event record for Ketoconazole + Phytosphingosine

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

16
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
3
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.
16
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

KetoconazolePhytosphingosine

Administration Routes

Auricular (Otic)Ophthalmic

Species Affected

Dog 9
Cat 5
Human 2

Most Affected Breeds

Domestic Shorthair 2
Spaniel - Cocker American 2
Domestic Longhair 2
Dog (unknown) 2
Unknown 2
Mountain Cur 1
Crossbred Canine/dog 1
Mixed (Dog) 1
Retriever - Labrador 1
Siberian Husky 1

Most Reported Reactions

Application site erythema 3
Loss of hearing 2
Emesis 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Application site pustule 2
Application site papule 2
Tympanic rupture 1
Anorexia 1
Hyperthermia 1
Anisocoria 1
Head shake - ear disorder 1
Otitis externa 1

Outcome Breakdown

Ongoing
10 (62.5%)
Recovered/Normal
3 (18.8%)
Outcome Unknown
3 (18.8%)

Ketoconazole + Phytosphingosine Adverse Event Insights

16 reports name Ketoconazole + Phytosphingosine; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredients: Ketoconazole, Phytosphingosine. Administration routes: Auricular (Otic), Ophthalmic.

By species: Dog (9 reports), Cat (5 reports), Human (2 reports). By breed: Domestic Shorthair (2), Spaniel - Cocker American (2), Domestic Longhair (2).

Leading clinical signs: Application site erythema (3), Loss of hearing (2), Emesis (2), Lethargy (see also Central nervous system depression in 'Neurological') (2). Outcome, 16 coded reports: Ongoing leads at 62.5%.

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.