Drug profile

The FDA adverse-event record for Dexmedetomidine Hydrochloride

4,754 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Dexmedetomidine Hydrochloride. See the species affected, top reactions, and outcomes below.

4,754
adverse-event reports
13.7%
death-coded share
Dog
most-reported species
649
INEFFECTIVE, SEDATION - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
4,754
Total Reports
653
Deaths Reported
13.7%
Death Rate

Active Ingredients

Dexmedetomidine Hydrochloride

Administration Routes

IntramuscularUnknownIntravenousBuccalSublingualOralSubcutaneousOtherTopicalParenteral

Species Affected

Dog 3,291
Cat 1,172
Unknown 175
Human 44
Rabbit 14
Rat 6
Other 5
Horse 4
Other Mammals 4
Guinea Pig 4

Most Affected Breeds

Dog (unknown) 585
Domestic Shorthair 490
Retriever - Labrador 320
Unknown 277
Domestic (unspecified) 157
Cat (unknown) 155
Cat (other) 129
Terrier - Bull - American Pit 119
Shepherd Dog - German 118
Crossbred Canine/dog 118

Most Reported Reactions

INEFFECTIVE, SEDATION 649
Lack of efficacy - NOS 562
Bradycardia 501
Death 466
Vomiting 351
Cardiac arrest 304
Lethargy (see also Central nervous system depression in 'Neurological') 246
Sedation prolonged 217
Sedation 201
Hypersalivation 182
Underdose 180
Anorexia 176

Outcome Breakdown

Recovered/Normal
1,656 (41.5%)
Ongoing
1,136 (28.4%)
Outcome Unknown
545 (13.6%)
Died
537 (13.4%)
Euthanized
118 (3.0%)
Recovered with Sequela
3 (0.1%)

Dexmedetomidine Hydrochloride Adverse Event Insights

4,754 reports name Dexmedetomidine Hydrochloride; 653 recorded a death outcome (13.7% of reported events, not a population-level mortality rate). Active ingredient: Dexmedetomidine Hydrochloride. Administration routes: Intramuscular, Unknown, Intravenous, Buccal.

By species: Dog (3,291 reports), Cat (1,172 reports), Unknown (175 reports). By breed: Dog (unknown) (585), Domestic Shorthair (490), Retriever - Labrador (320).

Leading clinical signs: INEFFECTIVE, SEDATION (649), Lack of efficacy - NOS (562), Bradycardia (501), Death (466). Outcome, 3,995 coded reports: Recovered/Normal leads at 41.5%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

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.