milbemycin oxime, lufenuron — FDA Animal & Veterinary ADE Reports by Species (Dog vs Cat)
Source: openFDA animalandveterinary/event.json, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-08-16. This topic covers adverse-event reports for the active ingredient Milbemycin Oxime, Lufenuron (queried as drug.active_ingredients.name). Overall report total for this ingredient: 8457. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. "Serious" follows the FDA serious_ae flag. Species values are as filed in each report. The Dog and Cat figures below are subsets of this ingredient's overall report total and do not necessarily sum to it (other species and reports with no species listed are excluded).
Dog (8238 reports)
- Serious adverse events (FDA
serious_aeflag): 1166 (14.2% of 8238) - Top reported reactions (VEDDRA terms):
- Lack of efficacy (endoparasite) - hookworm 1402
- INEFFECTIVE, HEARTWORM LARVAE 1363
- Vomiting 1325
- INEFFECTIVE, ASCARIDS NOS 824
- Diarrhoea 723
Cat (11 reports)
- Serious adverse events (FDA
serious_aeflag): 4 (36.4% of 11) - Top reported reactions (VEDDRA terms):
- Accidental exposure 6
- Lethargy (see also Central nervous system depression in 'Neurological') 5
- Vomiting 3
- Anxiety 1
- Ataxia 1
Honest scope note
This topic is a species cross-section of FDA adverse-event reports for a single active ingredient, queried by drug.active_ingredients.name. Figures are aggregates of spontaneously reported adverse events and reflect reporting volume, not incidence or risk per animal treated. "Lack of efficacy" and similar terms denote product-performance reports, not adverse reactions. Different marketed presentations of the same compound (e.g. chewable vs spot-on) may be filed under distinct name strings in openFDA and are not merged here. Source JSON: pdf-raw/ade/ade_species_slice_expand_2026-08-16.json (openFDA animalandveterinary/event.json, pulled 2026-08-16).