Milbemycin Oxime, Lufenuron, Praziquantel

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74 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.
74
Total Reports
1
Deaths Reported
140.0%
Death Rate

Active Ingredients

Milbemycin Oxime, Lufenuron, Praziquantel

Administration Routes

OralUnknown

Species Affected

Dog 73
Unknown 1

Most Affected Breeds

Dog (unknown) 30
Retriever - Labrador 8
Shepherd Dog - German 5
Beagle 4
Crossbred Canine/dog 3
Corgi - Welsh Cardigan 2
Collie - Border 2
Boxer (German Boxer) 1
Pit Bull 1
Poodle - Toy 1

Most Reported Reactions

Vomiting 16
INEFFECTIVE, HOOKS 12
Lack of efficacy (endoparasite) - heartworm 9
Diarrhoea 8
Lethargy (see also Central nervous system depression in 'Neurological') 8
Lack of efficacy (flea) 6
Lack of efficacy (heartworm) 6
Seizure NOS 2
Urinary incontinence 2
Elevated alanine aminotransferase (ALT) 2
Loose stool 2
Lack of efficacy (endoparasite) - roundworm NOS 2

Outcome Breakdown

Outcome Unknown
54 (77.1%)
Recovered/Normal
12 (17.1%)
Ongoing
3 (4.3%)
Died
1 (1.4%)

Data Summary

Metric Value
Total adverse event reports 74
Reports involving death 1
Case-fatality rate (reported events) 140.0%
Distinct species in reports 2
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.

Milbemycin Oxime, Lufenuron, Praziquantel Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 74 adverse event reports referencing Milbemycin Oxime, Lufenuron, Praziquantel, including 1 reports in which the animal died — a 140.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Milbemycin Oxime, Lufenuron, Praziquantel. 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 Milbemycin Oxime, Lufenuron, Praziquantel reports are Dog (73 reports), Unknown (1 reports), with Dog accounting for the largest share. Within those species, Dog (unknown) (30), Retriever - Labrador (8), Shepherd Dog - German (5) 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 Milbemycin Oxime, Lufenuron, Praziquantel are Vomiting (16), INEFFECTIVE, HOOKS (12), Lack of efficacy (endoparasite) - heartworm (9), Diarrhoea (8). Of the 70 reports with a coded outcome, Outcome Unknown is the leading category at 77.1%. 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 Milbemycin Oxime, Lufenuron, Praziquantel.

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