Reaction profile

The FDA adverse-event record for drowsiness - systemic disorder

184 FDA adverse-event reports reference drowsiness - systemic disorder (VeDDRA 2530). See the species, breeds, and drugs most associated with it below.

184
reports citing this reaction
7.1%
death-coded share
Dog
most-affected species
Gabapentin
most-associated drug
Verify with FDA CVM →
184
Total Reports
13
Deaths
7.1%
Death Rate

Species Most Affected

Dog 135
Cat 35
Human 12
Horse 1
Goat 1

Breeds Most Affected

Domestic Shorthair 24
Retriever - Labrador 13
Unknown 12
Dog (unknown) 11
Shih Tzu 8
Shepherd Dog - German 7
Pit Bull 5
Boxer (German Boxer) 5
Retriever - Golden 5
Chihuahua 5

Associated Drugs

Gabapentin 15
Oclacitinib Maleate 13
Milbemycin Oxime + Spinosad 13
Dexmedetomidine Hydrochloride 11
Pyrantel Pamoate;Sarolaner 11
Maropitant Citrate 10
Nitenpyram 10
Butorphanol 9
Grapiprant 8
Milbemycin Oxime + Praziquantel 8
Carprofen 8
Bedinvetmab 7
Fluralaner Spot-On Solution 6
Afoxolaner 6
Fluralaner 13.64% 12-Week Chew 6
Sarolaner 6
Propofol 6
Robenacoxib 5
Famotidine 5
Buprenorphine 5

Drowsiness - systemic disorder Reaction Insights

184 reports name Drowsiness - systemic disorder; 13 recorded a death outcome (7.1% of reported events, not a population-level mortality rate). VeDDRA code: 2530.

By species: Dog (135 reports), Cat (35 reports), Human (12 reports). By breed: Domestic Shorthair (24), Retriever - Labrador (13), Unknown (12).

Most co-reported drugs: Gabapentin (15 reports), Oclacitinib Maleate (13 reports), Milbemycin Oxime + Spinosad (13 reports), Dexmedetomidine Hydrochloride (11 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.