Fipronil 10%/S Methoprene 12% Spot On

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47 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.
47
Total Reports
2
Deaths Reported
430.0%
Death Rate

Active Ingredients

Fipronil 10%/S Methoprene 12% Spot On

Administration Routes

TopicalUnknownOther

Species Affected

Cat 43
Dog 4

Most Affected Breeds

Domestic Shorthair 24
Domestic Mediumhair 6
Cat (unknown) 5
Mixed (Cat) 2
Unknown 1
Himalayan 1
Retriever - Labrador 1
Spaniel - King Charles Cavalier 1
Crossbred Canine/dog 1
Havanese 1

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 14
Application site hair loss 7
Lethargy (see also Central nervous system depression in 'Neurological') 6
Vomiting 6
Application site irritation 4
Hair loss NOS 4
Behavioural disorder NOS 3
Scratching 3
Reddening of the skin 3
Skin sore 2
Application site ulcer 2
Application site hair change 2

Outcome Breakdown

Outcome Unknown
30 (63.8%)
Recovered/Normal
8 (17.0%)
Ongoing
7 (14.9%)
Euthanized
1 (2.1%)
Died
1 (2.1%)

Data Summary

Metric Value
Total adverse event reports 47
Reports involving death 2
Case-fatality rate (reported events) 430.0%
Distinct species in reports 2
Distinct breeds in reports 14
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 12% Spot On Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 47 adverse event reports referencing Fipronil 10%/S Methoprene 12% Spot On, including 2 reports in which the animal died — a 430.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fipronil 10%/S Methoprene 12% Spot On. Reported administration routes include Topical, Unknown, Other. 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 12% Spot On reports are Cat (43 reports), Dog (4 reports), with Cat accounting for the largest share. Within those species, Domestic Shorthair (24), Domestic Mediumhair (6), Cat (unknown) (5) 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 12% Spot On are Lack of efficacy (ectoparasite) - flea (14), Application site hair loss (7), Lethargy (see also Central nervous system depression in 'Neurological') (6), Vomiting (6). Of the 47 reports with a coded outcome, Outcome Unknown is the leading category at 63.8%. 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 10%/S Methoprene 12% 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