Drug profile

The FDA adverse-event record for Phytosphingosine Hydrochloride

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

122
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
18
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.
122
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Phytosphingosine Hydrochloride

Administration Routes

TopicalAuricular (Otic)OphthalmicUnknown

Species Affected

Dog 95
Cat 19
Human 8

Most Affected Breeds

Crossbred Canine/dog 11
Domestic Shorthair 9
Mixed (Dog) 9
Unknown 8
Dog (unknown) 7
Shih Tzu 6
Retriever - Labrador 5
Shepherd Dog - German 4
Terrier - Yorkshire 4
Beagle 3

Most Reported Reactions

Application site erythema 18
Pruritus 11
Erythema (for urticaria see Immune SOC) 9
Application site pruritus 8
Emesis 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Ear discharge 5
Hives (see also 'Skin') 5
Vomiting 5
Ataxia 5
Application site dermatitis 5
Anorexia 4

Outcome Breakdown

Recovered/Normal
52 (42.6%)
Ongoing
44 (36.1%)
Outcome Unknown
18 (14.8%)
Recovered with Sequela
8 (6.6%)

Phytosphingosine Hydrochloride Adverse Event Insights

122 reports name Phytosphingosine Hydrochloride; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Phytosphingosine Hydrochloride. Administration routes: Topical, Auricular (Otic), Ophthalmic, Unknown.

By species: Dog (95 reports), Cat (19 reports), Human (8 reports). By breed: Crossbred Canine/dog (11), Domestic Shorthair (9), Mixed (Dog) (9).

Leading clinical signs: Application site erythema (18), Pruritus (11), Erythema (for urticaria see Immune SOC) (9), Application site pruritus (8). Outcome, 122 coded reports: Recovered/Normal leads at 42.6%.

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.