Drug profile

The FDA adverse-event record for Phytosphingosine Hydrochloride + Salicylic Acid

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

16
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
2
Burning sensation of eye - 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

Phytosphingosine HydrochlorideSalicylic Acid

Administration Routes

Auricular (Otic)TopicalOralOther

Species Affected

Dog 7
Human 7
Cat 2

Most Affected Breeds

Unknown 7
Domestic Shorthair 2
Pit Bull 2
Pug 1
Shar Pei 1
Dog (unknown) 1
Retriever - Labrador 1
Crossbred Canine/dog 1

Most Reported Reactions

Burning sensation of eye 2
Headache 2
Eye irritation 2
Vomiting 1
Anorexia 1
Hind limb ataxia 1
Horner's syndrome 1
Ataxia 1
Lethargy (see also Central nervous system depression in 'Neurological') 1
Application site erythema 1
Pinnae disorder 1
Tongue disorder NOS 1

Outcome Breakdown

Ongoing
9 (56.3%)
Recovered/Normal
6 (37.5%)
Outcome Unknown
1 (6.3%)

Phytosphingosine Hydrochloride + Salicylic Acid Adverse Event Insights

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

By species: Dog (7 reports), Human (7 reports), Cat (2 reports). By breed: Unknown (7), Domestic Shorthair (2), Pit Bull (2).

Leading clinical signs: Burning sensation of eye (2), Headache (2), Eye irritation (2), Vomiting (1). Outcome, 16 coded reports: Ongoing leads at 56.3%.

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.