Reaction profile

The FDA adverse-event record for product problem

10,341 FDA adverse-event reports reference product problem (VeDDRA 2283). See the species, breeds, and drugs most associated with it below.

10,341
reports citing this reaction
0.3%
death-coded share
Unknown
most-affected species
Milbemycin Oxime + Spinosad
most-associated drug
Verify with FDA CVM →
10,341
Total Reports
32
Deaths
0.3%
Death Rate

Species Most Affected

Unknown 9,489
Dog 733
Cat 85
Human 20
Cattle 5
Horse 5
Sheep 2
Other 1
Pig 1

Breeds Most Affected

Unknown 9,536
Dog (unknown) 131
Crossbred Canine/dog 104
Retriever - Labrador 42
Chihuahua 38
Domestic Shorthair 35
Shepherd Dog - German 28
Cat (unknown) 27
Shih Tzu 27
Terrier - Yorkshire 18

Associated Drugs

Milbemycin Oxime + Spinosad 2,624
Fluralaner Chew Tablets 1,266
Spinosad 899
Nitenpyram 692
Fluralaner 13.64% 12-Week Chew 492
Cyclosporine 375
Fluralaner Spot-On Solution 283
Cyclosporin Ointment 262
Meloxicam 252
Ivermectin + Pyrantel 184
Lufenuron + Milbemycin Oxime 169
Milbemycin Oxime, Lufenuron 156
Insulin Injectable Vial 149
Milbemycin Oxime 147
Grapiprant 145
Lufenuron + Milbemycin Oxime + Praziquantel 123
Imidacloprid + Moxidectin 119
Deracoxib 116
Genta/Momet/Clotrim Ear Oint 111
Pimobendan 107

Product problem Reaction Insights

10,341 reports name Product problem; 32 recorded a death outcome (0.3% of reported events, not a population-level mortality rate). VeDDRA code: 2283.

By species: Unknown (9,489 reports), Dog (733 reports), Cat (85 reports). By breed: Unknown (9,536), Dog (unknown) (131), Crossbred Canine/dog (104).

Most co-reported drugs: Milbemycin Oxime + Spinosad (2,624 reports), Fluralaner Chew Tablets (1,266 reports), Spinosad (899 reports), Nitenpyram (692 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

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.