Phytosphingosine + Hypoallergenic Cleansing Bases

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16 adverse event reports submitted to the FDA

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 + Hypoallergenic Cleansing Bases

Administration Routes

Auricular (Otic)

Species Affected

Dog 14
Cat 2

Most Affected Breeds

Retriever - Golden 2
Retriever - Labrador 2
Domestic Shorthair 2
Dachshund - Standard Long-haired 1
Spaniel - Cocker American 1
Schipperke 1
Boxer (German Boxer) 1
Pekingese 1
Terrier - Tibetan 1
Terrier - West Highland White 1

Most Reported Reactions

Lack of efficacy - NOS 8
Behavioural disorder NOS 3
Loss of hearing 3
Deafness 2
Vocalisation 1
Anxiety 1
Aural haematoma 1
CULTURE/TITER DATA ABNORMAL 1
Elevated serum alkaline phosphatase (SAP) 1
Elevated alanine aminotransferase (ALT) 1
Head shake - ear disorder 1
Ocular discharge 1

Outcome Breakdown

Outcome Unknown
9 (56.3%)
Ongoing
4 (25.0%)
Recovered with Sequela
2 (12.5%)
Recovered/Normal
1 (6.3%)

Data Summary

Metric Value
Total adverse event reports 16
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 2
Distinct breeds in reports 13
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Phytosphingosine + Hypoallergenic Cleansing Bases Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 16 adverse event reports referencing Phytosphingosine + Hypoallergenic Cleansing Bases, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Phytosphingosine + Hypoallergenic Cleansing Bases. Reported administration route is Auricular (Otic). These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Phytosphingosine + Hypoallergenic Cleansing Bases reports are Dog (14 reports), Cat (2 reports), with Dog accounting for the largest share. Within those species, Retriever - Golden (2), Retriever - Labrador (2), Domestic Shorthair (2) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Phytosphingosine + Hypoallergenic Cleansing Bases are Lack of efficacy - NOS (8), Behavioural disorder NOS (3), Loss of hearing (3), Deafness (2). Of the 16 reports with a coded outcome, Outcome Unknown is the leading category at 56.3%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Phytosphingosine + Hypoallergenic Cleansing Bases.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial