Reaction profile

The FDA adverse-event record for sleepiness - systemic disorder

1,542 FDA adverse-event reports reference sleepiness - systemic disorder (VeDDRA 2529). See the species, breeds, and drugs most associated with it below.

1,542
reports citing this reaction
6.9%
death-coded share
Dog
most-affected species
Milbemycin Oxime + Spinosad
most-associated drug
Verify with FDA CVM →
1,542
Total Reports
106
Deaths
6.9%
Death Rate

Species Most Affected

Dog 1,112
Cat 421
Human 8
Other Equids 1

Breeds Most Affected

Domestic Shorthair 251
Retriever - Labrador 84
Crossbred Canine/dog 83
Chihuahua 76
Dog (unknown) 66
Retriever - Golden 49
Shih Tzu 48
Pit Bull 40
Terrier - Yorkshire 38
Domestic Longhair 35

Associated Drugs

Milbemycin Oxime + Spinosad 118
Trilostane 114
Nitenpyram 87
Milbemycin Oxime + Praziquantel 77
Maropitant Citrate 70
Gabapentin 65
Afoxolaner 65
Pyrantel Pamoate;Sarolaner 65
Oclacitinib Maleate 64
Fluralaner 13.64% 12-Week Chew 59
Bedinvetmab 59
Ivermectin + Pyrantel As Pamoate Salt 53
Grapiprant 52
Buprenorphine 52
Fluralaner Spot-On Solution 50
Carprofen 47
Lotilaner 42
Robenacoxib 41
Fluralaner Chew Tablets 37
Selamectin;Sarolaner 36

Sleepiness - systemic disorder Reaction Insights

1,542 reports name Sleepiness - systemic disorder; 106 recorded a death outcome (6.9% of reported events, not a population-level mortality rate). VeDDRA code: 2529.

By species: Dog (1,112 reports), Cat (421 reports), Human (8 reports). By breed: Domestic Shorthair (251), Retriever - Labrador (84), Crossbred Canine/dog (83).

Most co-reported drugs: Milbemycin Oxime + Spinosad (118 reports), Trilostane (114 reports), Nitenpyram (87 reports), Milbemycin Oxime + Praziquantel (77 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.