Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution

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117 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.
117
Total Reports
1
Deaths Reported
90.0%
Death Rate

Active Ingredients

Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution

Administration Routes

OtherUnknownOral

Species Affected

Dog 117

Most Affected Breeds

Dog (unknown) 11
Retriever - Labrador 8
Retriever - Golden 7
Crossbred Canine/dog 7
Terrier - Yorkshire 6
Bichon Frise 5
Maltese 4
Beagle 4
Dog (other) 4
Shih Tzu 4

Most Reported Reactions

Vomiting 33
Lethargy (see also Central nervous system depression in 'Neurological') 17
Diarrhoea 14
Seizure NOS 9
Lack of efficacy (flea) 9
Behavioural disorder NOS 8
Itching 8
Anorexia 7
Application site reddening 7
Appetite loss 6
Application site hair change 5
Hyperactivity 5

Outcome Breakdown

Recovered/Normal
58 (49.6%)
Outcome Unknown
56 (47.9%)
Ongoing
2 (1.7%)
Died
1 (0.9%)

Data Summary

Metric Value
Total adverse event reports 117
Reports involving death 1
Case-fatality rate (reported events) 90.0%
Distinct species in reports 1
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.

Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 117 adverse event reports referencing Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution, including 1 reports in which the animal died — a 90.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution. Reported administration routes include Other, Unknown, Oral. 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 Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution reports are Dog (117 reports), with Dog accounting for the largest share. Within those species, Dog (unknown) (11), Retriever - Labrador (8), Retriever - Golden (7) 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 Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution are Vomiting (33), Lethargy (see also Central nervous system depression in 'Neurological') (17), Diarrhoea (14), Seizure NOS (9). Of the 117 reports with a coded outcome, Recovered/Normal is the leading category at 49.6%. 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 Fipronil 9.8% / S-Methoprene 8.8% / Pyriproxyfen 0.25% Topical Solution.

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