Drug profile

The FDA adverse-event record for Phytosphingosine Salicyloyl

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

76
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
21
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.
76
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Phytosphingosine Salicyloyl

Administration Routes

TopicalAuricular (Otic)Oral

Species Affected

Dog 63
Cat 12
Human 1

Most Affected Breeds

Crossbred Canine/dog 12
Domestic Shorthair 9
Mixed (Dog) 8
Retriever - Labrador 6
Dog (unknown) 4
Shepherd Dog - German 3
Terrier - Boston 3
Dachshund - Miniature 3
Boxer (German Boxer) 2
Maltese 2

Most Reported Reactions

Application site erythema 21
Application site irritation 7
Application site pruritus 7
Lack of efficacy - NOS 7
Application site reddening 5
Pruritus 3
Other abnormal test result NOS 3
Behavioural disorder NOS 3
Swollen eye 3
Hives (see also 'Skin') 3
Application site inflammation 3
Eye redness 2

Outcome Breakdown

Recovered/Normal
39 (51.3%)
Ongoing
23 (30.3%)
Outcome Unknown
13 (17.1%)
Recovered with Sequela
1 (1.3%)

Phytosphingosine Salicyloyl Adverse Event Insights

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

By species: Dog (63 reports), Cat (12 reports), Human (1 reports). By breed: Crossbred Canine/dog (12), Domestic Shorthair (9), Mixed (Dog) (8).

Leading clinical signs: Application site erythema (21), Application site irritation (7), Application site pruritus (7), Lack of efficacy - NOS (7). Outcome, 76 coded reports: Recovered/Normal leads at 51.3%.

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.