Fipronil/Methoprene

Verify with FDA CVM →

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
2
Deaths Reported
1250.0%
Death Rate

Active Ingredients

Fipronil/Methoprene

Administration Routes

TopicalUnknown

Species Affected

Cat 8
Dog 8

Most Affected Breeds

Domestic Shorthair 8
Terrier - Yorkshire 2
Spitz - American Eskimo Dog 1
Collie (unspecified) 1
Shepherd Dog - German 1
Mixed (Dog) 1
Shepherd Dog - Belgian Laekenois 1
Terrier - Border 1

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 4
Stiffness limb 3
Hyperactivity 2
Vocalisation 2
Scratching 2
Seizure NOS 2
Cardiac enlargement 2
Limb weakness 2
Paraparesis 2
Pulmonary disorder NOS 2
Urinary retention 2
Lateral recumbency 2

Outcome Breakdown

Recovered/Normal
7 (43.8%)
Ongoing
5 (31.3%)
Outcome Unknown
2 (12.5%)
Euthanized
2 (12.5%)

Data Summary

Metric Value
Total adverse event reports 16
Reports involving death 2
Case-fatality rate (reported events) 1250.0%
Distinct species in reports 2
Distinct breeds in reports 8
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/Methoprene Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 16 adverse event reports referencing Fipronil/Methoprene, including 2 reports in which the animal died — a 1250.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fipronil/Methoprene. 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 Fipronil/Methoprene reports are Cat (8 reports), Dog (8 reports), with Cat accounting for the largest share. Within those species, Domestic Shorthair (8), Terrier - Yorkshire (2), Spitz - American Eskimo Dog (1) 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/Methoprene are Lack of efficacy (ectoparasite) - flea (4), Stiffness limb (3), Hyperactivity (2), Vocalisation (2). Of the 16 reports with a coded outcome, Recovered/Normal is the leading category at 43.8%. 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/Methoprene.

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