Spinosad / Milbemycin Oxime

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15 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.
15
Total Reports
1
Deaths Reported
670.0%
Death Rate

Active Ingredients

Spinosad / Milbemycin Oxime

Administration Routes

OralTopical

Species Affected

Dog 15

Most Affected Breeds

Retriever - Labrador 4
Terrier - Jack Russell 2
Beagle 1
Terrier - Yorkshire 1
Pit Bull 1
Dachshund (unspecified) 1
Retriever - Golden 1
Chihuahua 1
Terrier - Bull - Staffordshire 1
Bichon Frise 1

Most Reported Reactions

INEFFECTIVE, HEARTWORM LARVAE 4
INEFFECTIVE, ATOPY CONTROL 2
Underdose 2
Vomiting 2
Other abnormal test result NOS 2
Elevated serum alkaline phosphatase (SAP) 2
Elevated alanine aminotransferase (ALT) 2
Agitation 1
Restlessness 1
Crying 1
Constipation 1
Seizure NOS 1

Outcome Breakdown

Outcome Unknown
7 (46.7%)
Ongoing
4 (26.7%)
Recovered/Normal
3 (20.0%)
Died
1 (6.7%)

Data Summary

Metric Value
Total adverse event reports 15
Reports involving death 1
Case-fatality rate (reported events) 670.0%
Distinct species in reports 1
Distinct breeds in reports 11
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.

Spinosad / Milbemycin Oxime Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 15 adverse event reports referencing Spinosad / Milbemycin Oxime, including 1 reports in which the animal died — a 670.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Spinosad / Milbemycin Oxime. Reported administration routes include Oral, Topical. 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 Spinosad / Milbemycin Oxime reports are Dog (15 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (4), Terrier - Jack Russell (2), Beagle (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 Spinosad / Milbemycin Oxime are INEFFECTIVE, HEARTWORM LARVAE (4), INEFFECTIVE, ATOPY CONTROL (2), Underdose (2), Vomiting (2). Of the 15 reports with a coded outcome, Outcome Unknown is the leading category at 46.7%. 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 Spinosad / Milbemycin Oxime.

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