Drug profile

The FDA adverse-event record for Dexmedetomidine Hydrochloride Injection

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

55
adverse-event reports
7.3%
death-coded share
Dog
most-reported species
32
Lack of efficacy - NOS - 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.
55
Total Reports
4
Deaths Reported
7.3%
Death Rate

Active Ingredients

Dexmedetomidine Hydrochloride Injection

Administration Routes

IntramuscularUnknownIntravenousOphthalmic

Species Affected

Dog 45
Cat 7
Unknown 2
Human 1

Most Affected Breeds

Dog (unknown) 9
Shepherd Dog - German 4
Unknown 3
Cat (unknown) 3
Retriever - Labrador 3
Terrier (unspecified) 3
Shih Tzu 3
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 2
Dachshund (unspecified) 2
Retriever - Golden 2

Most Reported Reactions

Lack of efficacy - NOS 32
Defect Unknown/Not Specified 12
INEFFECTIVE, SEDATION 10
Bradycardia 5
Increased heart rate 3
Decreased appetite 3
Hypertension 2
Unrelated death 2
Respiratory arrest 2
Decreased heart rate 2
Cardiac arrest 2
Emesis 2

Outcome Breakdown

Recovered/Normal
41 (77.4%)
Outcome Unknown
8 (15.1%)
Died
2 (3.8%)
Euthanized
2 (3.8%)

Dexmedetomidine Hydrochloride Injection Adverse Event Insights

55 reports name Dexmedetomidine Hydrochloride Injection; 4 recorded a death outcome (7.3% of reported events, not a population-level mortality rate). Active ingredient: Dexmedetomidine Hydrochloride Injection. Administration routes: Intramuscular, Unknown, Intravenous, Ophthalmic.

By species: Dog (45 reports), Cat (7 reports), Unknown (2 reports). By breed: Dog (unknown) (9), Shepherd Dog - German (4), Unknown (3).

Leading clinical signs: Lack of efficacy - NOS (32), Defect Unknown/Not Specified (12), INEFFECTIVE, SEDATION (10), Bradycardia (5). Outcome, 53 coded reports: Recovered/Normal leads at 77.4%.

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.