Drug profile

The FDA adverse-event record for Phytosphingosine

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

111
adverse-event reports
1.8%
death-coded share
Dog
most-reported species
15
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.
111
Total Reports
2
Deaths Reported
1.8%
Death Rate

Active Ingredients

Phytosphingosine

Administration Routes

TopicalUnknownAuricular (Otic)OralNasalCutaneous

Species Affected

Dog 96
Cat 8
Human 6
Rabbit 1

Most Affected Breeds

Retriever - Golden 7
Crossbred Canine/dog 7
Terrier - Yorkshire 7
Unknown 6
Bulldog 5
Retriever - Labrador 5
Spaniel - Cocker American 4
Pit Bull 4
Shepherd Dog - German 4
Chihuahua 4

Most Reported Reactions

Vomiting 15
Pruritus 13
Lack of efficacy - NOS 13
Erythema (for urticaria see Immune SOC) 11
Behavioural disorder NOS 10
Other abnormal test result NOS 10
Diarrhoea 9
Lethargy (see also Central nervous system depression in 'Neurological') 8
Hives (see also 'Skin') 7
Ear discharge 7
Alopecia local 7
Unclassifiable adverse event 6

Outcome Breakdown

Recovered/Normal
42 (39.6%)
Outcome Unknown
31 (29.2%)
Ongoing
24 (22.6%)
Recovered with Sequela
7 (6.6%)
Died
1 (0.9%)
Euthanized
1 (0.9%)

Phytosphingosine Adverse Event Insights

111 reports name Phytosphingosine; 2 recorded a death outcome (1.8% of reported events, not a population-level mortality rate). Active ingredient: Phytosphingosine. Administration routes: Topical, Unknown, Auricular (Otic), Oral.

By species: Dog (96 reports), Cat (8 reports), Human (6 reports). By breed: Retriever - Golden (7), Crossbred Canine/dog (7), Terrier - Yorkshire (7).

Leading clinical signs: Vomiting (15), Pruritus (13), Lack of efficacy - NOS (13), Erythema (for urticaria see Immune SOC) (11). Outcome, 106 coded reports: Recovered/Normal leads at 39.6%.

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.