Drug profile

The FDA adverse-event record for Flea Shampoo

442 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Flea Shampoo. See the species affected, top reactions, and outcomes below.

442
adverse-event reports
1.1%
death-coded share
Dog
most-reported species
257
Lack of efficacy (ectoparasite) - flea - 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.
442
Total Reports
5
Deaths Reported
1.1%
Death Rate

Active Ingredients

Flea Shampoo

Administration Routes

TopicalCutaneousUnknownImmersionOral

Species Affected

Dog 358
Cat 83
Human 1

Most Affected Breeds

Chihuahua 50
Domestic Shorthair 36
Crossbred Canine/dog 30
Dog (unknown) 29
Terrier - Yorkshire 22
Retriever - Labrador 20
Shih Tzu 19
Maltese 13
Pit Bull 11
Dachshund (unspecified) 10

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 257
Lack of efficacy (flea) 83
Pruritus 39
Lack of efficacy - NOS 29
Lethargy (see also Central nervous system depression in 'Neurological') 27
Vomiting 21
Itching 20
Scratching 19
Behavioural disorder NOS 17
Emesis 15
Overdose 11
Vocalisation 10

Outcome Breakdown

Outcome Unknown
320 (72.4%)
Ongoing
57 (12.9%)
Recovered/Normal
51 (11.5%)
Recovered with Sequela
9 (2.0%)
Died
5 (1.1%)

Flea Shampoo Adverse Event Insights

442 reports name Flea Shampoo; 5 recorded a death outcome (1.1% of reported events, not a population-level mortality rate). Active ingredient: Flea Shampoo. Administration routes: Topical, Cutaneous, Unknown, Immersion.

By species: Dog (358 reports), Cat (83 reports), Human (1 reports). By breed: Chihuahua (50), Domestic Shorthair (36), Crossbred Canine/dog (30).

Leading clinical signs: Lack of efficacy (ectoparasite) - flea (257), Lack of efficacy (flea) (83), Pruritus (39), Lack of efficacy - NOS (29). Outcome, 442 coded reports: Outcome Unknown leads at 72.4%.

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.