Fipronil 10%/S Methoprene 9% Spot On

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1,422 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.
1,422
Total Reports
23
Deaths Reported
160.0%
Death Rate

Active Ingredients

Fipronil 10%/S Methoprene 9% Spot On

Administration Routes

UnknownOtherTopicalOralSubcutaneousSublingualTransdermal

Species Affected

Dog 1,420
Human 1
Cat 1

Most Affected Breeds

Retriever - Labrador 151
Crossbred Canine/dog 89
Dog (unknown) 85
Retriever - Golden 73
Shih Tzu 68
Terrier - Yorkshire 55
Dog (other) 53
Chihuahua 47
Shepherd Dog - German 40
Maltese 29

Most Reported Reactions

Vomiting 326
Lethargy (see also Central nervous system depression in 'Neurological') 254
Lack of efficacy (ectoparasite) - flea 115
Behavioural disorder NOS 113
Diarrhoea 111
Seizure NOS 110
Skin disorders NOS 107
Lack of efficacy - NOS 61
Anorexia 50
Application site irritation 49
Pruritus 48
Scratching 46

Outcome Breakdown

Outcome Unknown
784 (55.1%)
Recovered/Normal
554 (38.9%)
Ongoing
60 (4.2%)
Euthanized
12 (0.8%)
Died
11 (0.8%)
Recovered with Sequela
3 (0.2%)

Data Summary

Metric Value
Total adverse event reports 1,422
Reports involving death 23
Case-fatality rate (reported events) 160.0%
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.

Fipronil 10%/S Methoprene 9% Spot On Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 1,422 adverse event reports referencing Fipronil 10%/S Methoprene 9% Spot On, including 23 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 10%/S Methoprene 9% Spot On. Reported administration routes include Unknown, Other, Topical, 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 10%/S Methoprene 9% Spot On reports are Dog (1,420 reports), Human (1 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (151), Crossbred Canine/dog (89), Dog (unknown) (85) 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 10%/S Methoprene 9% Spot On are Vomiting (326), Lethargy (see also Central nervous system depression in 'Neurological') (254), Lack of efficacy (ectoparasite) - flea (115), Behavioural disorder NOS (113). Of the 1,424 reports with a coded outcome, Outcome Unknown is the leading category at 55.1%. 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 10%/S Methoprene 9% Spot On.

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