Topical Skin Treatment (Unknown)

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43 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.
43
Total Reports
1
Deaths Reported
230.0%
Death Rate

Active Ingredients

Topical Skin Treatment (Unknown)

Administration Routes

TopicalUnknown

Species Affected

Dog 35
Cat 8

Most Affected Breeds

Terrier - West Highland White 3
Shepherd Dog - German 3
Domestic Shorthair 3
Spaniel - Cocker American 3
Terrier - Yorkshire 3
Retriever - Labrador 2
Bulldog 2
Chihuahua 2
Cat (unknown) 2
Terrier - Bull 2

Most Reported Reactions

Vomiting 11
Lethargy (see also Central nervous system depression in 'Neurological') 6
Not eating 6
Weight loss 5
Diarrhoea 4
Other abnormal test result NOS 4
Lethargy (see also Central nervous system depression in Neurological) 4
Elevated serum alkaline phosphatase (ALP) 4
Lack of efficacy - NOS 3
Lack of efficacy (ectoparasite) - flea 3
Behavioural disorder NOS 3
Febrile 3

Outcome Breakdown

Ongoing
18 (41.9%)
Recovered/Normal
12 (27.9%)
Outcome Unknown
10 (23.3%)
Recovered with Sequela
2 (4.7%)
Died
1 (2.3%)

Data Summary

Metric Value
Total adverse event reports 43
Reports involving death 1
Case-fatality rate (reported events) 230.0%
Distinct species in reports 2
Distinct breeds in reports 20
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.

Topical Skin Treatment (Unknown) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 43 adverse event reports referencing Topical Skin Treatment (Unknown), including 1 reports in which the animal died — a 230.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Topical Skin Treatment (Unknown). Reported administration routes include Topical, Unknown. 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 Topical Skin Treatment (Unknown) reports are Dog (35 reports), Cat (8 reports), with Dog accounting for the largest share. Within those species, Terrier - West Highland White (3), Shepherd Dog - German (3), Domestic Shorthair (3) 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 Topical Skin Treatment (Unknown) are Vomiting (11), Lethargy (see also Central nervous system depression in 'Neurological') (6), Not eating (6), Weight loss (5). Of the 43 reports with a coded outcome, Ongoing is the leading category at 41.9%. 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 Topical Skin Treatment (Unknown).

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