Drug profile

The FDA adverse-event record for Milbemycin/Lufenuron Tablets

3,628 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Milbemycin/Lufenuron Tablets. See the species affected, top reactions, and outcomes below.

3,628
adverse-event reports
1.5%
death-coded share
Dog
most-reported species
1,386
Lack of efficacy (endoparasite) - heartworm - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
3,628
Total Reports
53
Deaths Reported
1.5%
Death Rate

Active Ingredients

Milbemycin/Lufenuron Tablets

Administration Routes

OralUnknownTopicalIontophoresis

Species Affected

Dog 3,501
Unknown 120
Human 7

Most Affected Breeds

Crossbred Canine/dog 987
Retriever - Labrador 380
Retriever - Golden 159
Shepherd Dog - German 151
Unknown 129
Dog (unknown) 97
Pit Bull 93
Shepherd Dog - Australian 88
Beagle 79
Terrier (unspecified) 62

Most Reported Reactions

Lack of efficacy (endoparasite) - heartworm 1,386
Lack of efficacy (endoparasite) - hookworm 552
Vomiting 310
Lack of efficacy (endoparasite) - roundworm NOS 301
Lack of efficacy (ectoparasite) - flea 204
Emesis (multiple) 131
Diarrhoea 124
Lethargy (see also Central nervous system depression in 'Neurological') 112
Drug dose omission 101
Lack of efficacy (endoparasite) - whipworm 95
INEFFECTIVE, HOOKS 84
Underfilling, Package 80

Outcome Breakdown

Ongoing
2,673 (76.2%)
Recovered/Normal
679 (19.3%)
Outcome Unknown
78 (2.2%)
Euthanized
30 (0.9%)
Recovered with Sequela
26 (0.7%)
Died
24 (0.7%)

Milbemycin/Lufenuron Tablets Adverse Event Insights

3,628 reports name Milbemycin/Lufenuron Tablets; 53 recorded a death outcome (1.5% of reported events, not a population-level mortality rate). Active ingredient: Milbemycin/Lufenuron Tablets. Administration routes: Oral, Unknown, Topical, Iontophoresis.

By species: Dog (3,501 reports), Unknown (120 reports), Human (7 reports). By breed: Crossbred Canine/dog (987), Retriever - Labrador (380), Retriever - Golden (159).

Leading clinical signs: Lack of efficacy (endoparasite) - heartworm (1,386), Lack of efficacy (endoparasite) - hookworm (552), Vomiting (310), Lack of efficacy (endoparasite) - roundworm NOS (301). Outcome, 3,510 coded reports: Ongoing leads at 76.2%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.