Reaction profile

The FDA adverse-event record for off colour

220 FDA adverse-event reports reference off colour (VeDDRA 1028). See the species, breeds, and drugs most associated with it below.

220
reports citing this reaction
15.0%
death-coded share
Dog
most-affected species
Milbemycin Oxime + Spinosad
most-associated drug
Verify with FDA CVM →
220
Total Reports
33
Deaths
15.0%
Death Rate

Species Most Affected

Dog 195
Cat 16
Human 3
Horse 3
Chicken 1
Pig 1
Cattle 1

Breeds Most Affected

Chihuahua 20
Terrier - Yorkshire 14
Terrier (unspecified) 13
Domestic Shorthair 12
Retriever - Labrador 11
Boxer (German Boxer) 10
Spitz - German Pomeranian 7
Terrier - Boston 7
Poodle - Miniature 6
Shepherd Dog - German 5

Associated Drugs

Milbemycin Oxime + Spinosad 117
Spinosad 46
Trilostane 17
Unspecified 17
Ivermectin + Pyrantel Pamoate 7
Ivermectin 7
Dexmedetomidine Hydrochloride 6
Carprofen 6
Afoxolaner 68 Mg Chewable Tablets 6
Polysulfated Glycosaminoglycan 5
Vaccines (Unknown) 5
Buprenorphine 4
Firocoxib 4
Maropitant Citrate 4
Milbemycin Oxime + Praziquantel 4
Bordetella Vaccine 3
Distemper Vaccine 3
Da2Ppl Vaccine 3
Selamectin 3
Phenylpropanolamine Hcl 3

Off colour Reaction Insights

220 reports name Off colour; 33 recorded a death outcome (15.0% of reported events, not a population-level mortality rate). VeDDRA code: 1028.

By species: Dog (195 reports), Cat (16 reports), Human (3 reports). By breed: Chihuahua (20), Terrier - Yorkshire (14), Terrier (unspecified) (13).

Most co-reported drugs: Milbemycin Oxime + Spinosad (117 reports), Spinosad (46 reports), Trilostane (17 reports), Unspecified (17 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.