Spinosad, Milbemycin Oxime

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49 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.
49
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Spinosad, Milbemycin Oxime

Administration Routes

OralUnknown

Species Affected

Dog 49

Most Affected Breeds

Retriever - Labrador 9
Pit Bull 3
Crossbred Canine/dog 3
American Pit Bull Terrier 3
Brittany 2
Doberman Pinscher 2
Retriever - Golden 2
Collie (unspecified) 2
Beagle 2
Maltese 2

Most Reported Reactions

INEFFECTIVE, HEARTWORM LARVAE 24
Lethargy (see also Central nervous system depression in 'Neurological') 6
Weight loss 5
Vomiting 5
Lack of efficacy (endoparasite) - heartworm 5
Underdose 3
Lack of efficacy - NOS 3
Diarrhoea 3
Abnormal radiograph finding 3
Loose stool 3
Anorexia 3
High sodium-potassium ratio (Na:K ratio) 3

Outcome Breakdown

Ongoing
22 (44.9%)
Outcome Unknown
16 (32.7%)
Recovered/Normal
11 (22.4%)

Data Summary

Metric Value
Total adverse event reports 49
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 1
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.

Spinosad, Milbemycin Oxime Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 49 adverse event reports referencing Spinosad, Milbemycin Oxime, including 0 reports in which the animal died — a 0.0% 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, Unknown. 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 (49 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (9), Pit Bull (3), Crossbred Canine/dog (3) 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 (24), Lethargy (see also Central nervous system depression in 'Neurological') (6), Weight loss (5), Vomiting (5). Of the 49 reports with a coded outcome, Ongoing is the leading category at 44.9%. 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