Amitraz; Metaflumizone

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10 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.
10
Total Reports
1
Deaths Reported
1000.0%
Death Rate

Active Ingredients

Amitraz; Metaflumizone

Administration Routes

TopicalOral

Species Affected

Dog 10

Most Affected Breeds

Collie - Border 2
Coonhound - Bluetick 1
Catahoula Leopard Dog 1
Mastiff 1
Deutsche Dogge, Great Dane 1
Terrier - Bull - American Pit 1
Pug 1
Spitz - German Pomeranian 1
Shih Tzu 1

Most Reported Reactions

Lack of efficacy (ectoparasite) - Demodex 4
Skin lesion NOS 3
Other abnormal test result NOS 3
Pruritus 3
Lethargy (see also Central nervous system depression in 'Neurological') 3
Oedema of the extremities (see also other SOCs for most applicable oedema) 2
Erythema (for urticaria see Immune SOC) 2
Pyoderma 2
Hyperphosphataemia 2
Elevated serum alkaline phosphatase (SAP) 2
SKIN SCRAPING ABNORMAL 2
Seizure NOS 2

Outcome Breakdown

Ongoing
8 (80.0%)
Outcome Unknown
1 (10.0%)
Euthanized
1 (10.0%)

Data Summary

Metric Value
Total adverse event reports 10
Reports involving death 1
Case-fatality rate (reported events) 1000.0%
Distinct species in reports 1
Distinct breeds in reports 9
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.

Amitraz; Metaflumizone Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 10 adverse event reports referencing Amitraz; Metaflumizone, including 1 reports in which the animal died — a 1000.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Amitraz; Metaflumizone. Reported administration routes include 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 Amitraz; Metaflumizone reports are Dog (10 reports), with Dog accounting for the largest share. Within those species, Collie - Border (2), Coonhound - Bluetick (1), Catahoula Leopard 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 Amitraz; Metaflumizone are Lack of efficacy (ectoparasite) - Demodex (4), Skin lesion NOS (3), Other abnormal test result NOS (3), Pruritus (3). Of the 10 reports with a coded outcome, Ongoing is the leading category at 80.0%. 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 Amitraz; Metaflumizone.

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