Unspecified Flea Shampoo

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127 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.
127
Total Reports
1
Deaths Reported
80.0%
Death Rate

Active Ingredients

Unspecified Flea Shampoo

Administration Routes

TopicalUnknown

Species Affected

Dog 107
Cat 19
Other 1

Most Affected Breeds

Chihuahua 13
Domestic Shorthair 12
Terrier - Yorkshire 11
Cat (unknown) 6
Shepherd Dog - Australian 5
Retriever - Labrador 5
Dog (unknown) 5
Maltese 5
Spitz - German Pomeranian 5
Shih Tzu 4

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 106
Pruritus 14
Behavioural disorder NOS 5
Panting 5
Restlessness 4
Itching 4
Scratching 3
Hypersalivation 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Rolling 2
Skin lesion NOS 2
Whining 2

Outcome Breakdown

Outcome Unknown
112 (88.2%)
Recovered/Normal
8 (6.3%)
Ongoing
6 (4.7%)
Euthanized
1 (0.8%)

Data Summary

Metric Value
Total adverse event reports 127
Reports involving death 1
Case-fatality rate (reported events) 80.0%
Distinct species in reports 3
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.

Unspecified Flea Shampoo Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 127 adverse event reports referencing Unspecified Flea Shampoo, including 1 reports in which the animal died — a 80.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Unspecified Flea Shampoo. 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 Unspecified Flea Shampoo reports are Dog (107 reports), Cat (19 reports), Other (1 reports), with Dog accounting for the largest share. Within those species, Chihuahua (13), Domestic Shorthair (12), Terrier - Yorkshire (11) 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 Unspecified Flea Shampoo are Lack of efficacy (ectoparasite) - flea (106), Pruritus (14), Behavioural disorder NOS (5), Panting (5). Of the 127 reports with a coded outcome, Outcome Unknown is the leading category at 88.2%. 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 Unspecified Flea Shampoo.

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