Spinosad And Milbemycin Oxime

Verify with FDA CVM →

715 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.
715
Total Reports
34
Deaths Reported
480.0%
Death Rate

Active Ingredients

Spinosad And Milbemycin Oxime

Administration Routes

OralUnknownTopical

Species Affected

Dog 715

Most Affected Breeds

Retriever - Labrador 139
Shepherd Dog - German 48
Terrier - Bull - American Pit 30
Boxer (German Boxer) 23
Shepherd Dog - Australian 22
Beagle 21
Crossbred Canine/dog 21
Chihuahua 20
Retriever - Golden 18
Shih Tzu 18

Most Reported Reactions

Lack of efficacy (endoparasite) - heartworm 279
INEFFECTIVE, HEARTWORM LARVAE 88
Lethargy (see also Central nervous system depression in 'Neurological') 73
Vomiting 70
Lack of efficacy - NOS 43
Other abnormal test result NOS 38
Seizure NOS 33
Diarrhoea 32
Elevated alanine aminotransferase (ALT) 29
Anorexia 29
Elevated serum alkaline phosphatase (SAP) 27
Pale mucous membrane 18

Outcome Breakdown

Ongoing
551 (77.0%)
Recovered/Normal
75 (10.5%)
Outcome Unknown
56 (7.8%)
Died
19 (2.7%)
Euthanized
15 (2.1%)

Data Summary

Metric Value
Total adverse event reports 715
Reports involving death 34
Case-fatality rate (reported events) 480.0%
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 And Milbemycin Oxime Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 715 adverse event reports referencing Spinosad And Milbemycin Oxime, including 34 reports in which the animal died — a 480.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Spinosad And Milbemycin Oxime. Reported administration routes include Oral, Unknown, 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 And Milbemycin Oxime reports are Dog (715 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (139), Shepherd Dog - German (48), Terrier - Bull - American Pit (30) 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 And Milbemycin Oxime are Lack of efficacy (endoparasite) - heartworm (279), INEFFECTIVE, HEARTWORM LARVAE (88), Lethargy (see also Central nervous system depression in 'Neurological') (73), Vomiting (70). Of the 716 reports with a coded outcome, Ongoing is the leading category at 77.0%. 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 Spinosad And 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