Drug profile

The FDA adverse-event record for Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On

21 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On. See the species affected, top reactions, and outcomes below.

21
adverse-event reports
4.8%
death-coded share
Dog
most-reported species
13
Lethargy (see also Central nervous system depression in 'Neurological') - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
21
Total Reports
1
Deaths Reported
4.8%
Death Rate

Active Ingredients

Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On

Administration Routes

OtherUnknown

Species Affected

Dog 21

Most Affected Breeds

Retriever - Golden 4
Shepherd Dog - Australian 3
Collie - Border 2
Collie (unspecified) 1
Sheepdog - Shetland 1
Bulldog - French 1
Mixed (Dog) 1
Chihuahua 1
Retriever - Labrador 1
Pointing Dog - Italian Wire-haired 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 13
Vomiting 5
Other abnormal test result NOS 4
Application site irritation 3
Elevated alanine aminotransferase (ALT) 3
Pemphigus foliaceus 2
Walking difficulty 2
Flaking skin 2
Neutrophilia 2
Polyuria 2
Dermatitis 2
Erythema (for urticaria see Immune SOC) 2

Outcome Breakdown

Recovered/Normal
13 (61.9%)
Outcome Unknown
4 (19.0%)
Recovered with Sequela
2 (9.5%)
Ongoing
1 (4.8%)
Euthanized
1 (4.8%)

Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On Adverse Event Insights

21 reports name Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On; 1 recorded a death outcome (4.8% of reported events, not a population-level mortality rate). Active ingredient: Fipronil 9.8%/S-Methoprene 8.8%/ Amitraz 22.1% Spot-On. Administration routes: Other, Unknown.

By species: Dog (21 reports). By breed: Retriever - Golden (4), Shepherd Dog - Australian (3), Collie - Border (2).

Leading clinical signs: Lethargy (see also Central nervous system depression in 'Neurological') (13), Vomiting (5), Other abnormal test result NOS (4), Application site irritation (3). Outcome, 21 coded reports: Recovered/Normal leads at 61.9%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.