Fipronil + (S)-Methoprene

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367 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.
367
Total Reports
6
Deaths Reported
160.0%
Death Rate

Active Ingredients

Fipronil + (S)-Methoprene

Administration Routes

TopicalUnknownOralCutaneousIntraocular

Species Affected

Dog 305
Cat 62

Most Affected Breeds

Retriever - Labrador 41
Domestic Shorthair 24
Dog (unknown) 17
Crossbred Canine/dog 15
Cat (unknown) 15
Shepherd Dog - German 13
Domestic Longhair 11
Shih Tzu 9
Shepherd Dog - Australian 9
Dachshund (unspecified) 8

Most Reported Reactions

Emesis 94
Lack of efficacy (ectoparasite) - flea 67
Vomiting 46
Lethargy (see also Central nervous system depression in 'Neurological') 42
Lack of efficacy - NOS 40
Diarrhoea 18
Behavioural disorder NOS 16
Other abnormal test result NOS 16
Lack of efficacy (flea) 14
Lack of efficacy (endoparasite) - heartworm 14
Panting 12
Seizure NOS 11

Outcome Breakdown

Outcome Unknown
158 (43.1%)
Recovered/Normal
147 (40.1%)
Ongoing
40 (10.9%)
Recovered with Sequela
16 (4.4%)
Died
5 (1.4%)
Euthanized
1 (0.3%)

Data Summary

Metric Value
Total adverse event reports 367
Reports involving death 6
Case-fatality rate (reported events) 160.0%
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.

Fipronil + (S)-Methoprene Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 367 adverse event reports referencing Fipronil + (S)-Methoprene, including 6 reports in which the animal died — a 160.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fipronil + (S)-Methoprene. Reported administration routes include Topical, Unknown, Oral, Cutaneous. 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 + (S)-Methoprene reports are Dog (305 reports), Cat (62 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (41), Domestic Shorthair (24), Dog (unknown) (17) 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 + (S)-Methoprene are Emesis (94), Lack of efficacy (ectoparasite) - flea (67), Vomiting (46), Lethargy (see also Central nervous system depression in 'Neurological') (42). Of the 367 reports with a coded outcome, Outcome Unknown is the leading category at 43.1%. 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 + (S)-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