Pet Drug Reports

Dexmedetomidine hydrochloride (Dexdomitor, Dexmedesed)adverse event reports that FDA received

Active ingredient

Also sold as: Dexdomitor, Dexmedesed, Dexvetra, DexmedVet.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarianHow to report to FDA

From September 2007 to June 2026, FDA received 5,731 adverse event reports that name a drug with dexmedetomidine hydrochloride as its active ingredient. Of the 5,731 reports, 3,957 (69%) are about dogs. 1,434 reports are about cats (25%).

In January to March 2026, FDA received 75 reports that name this drug. The signs that appear in the largest number of the 5,731 reports are "Ineffective, sedation", "Lack of efficacy - NOS" and "Bradycardia". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 15.2% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about cats are 25% of the reports that name this drug, and 11% of all reports.

Since the last update of the FDA data

The site recorded an update of the FDA data on . FDA changed these counts for January to March 2026:

  • All species: from 67 to 75.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 75 reports that name dexmedetomidine hydrochloride: 45 dog, 23 cat, 1 horse, 6 other or not given.

All updatesFeed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 5,731 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Ineffective, sedation[legacy FDA term: the product did not have the expected effect (sedation)]16%916 reports
  2. Lack of efficacy - NOS[the product did not have the expected effect]11%633 reports
  3. Bradycardia[slow heart rate]10.1%576 reports
  4. Death10%574 reports
  5. Vomiting7%403 reports
  6. Cardiac arrest6.5%373 reports
  7. Lethargy[unusually tired or inactive]6.2%353 reports
  8. Sedation prolonged4.4%254 reports
  9. Hypersalivation[drooling]3.8%216 reports
  10. Sedation3.7%214 reports
  11. Apnoea[breathing stopped]3.7%211 reports
  12. Anorexia[not eating]3.6%204 reports
  13. Underdose[less than the labelled amount was given]3.4%193 reports
  14. Diarrhoea[diarrhea]3.4%192 reports
Show the next 16 signs
  1. Seizure NOS[seizure, type not specified]3.2%183 reports
  2. Pale mucous membrane[pale gums]3%172 reports
  3. Tachycardia[fast heart rate]3%172 reports
  4. Death by euthanasia[the animal was euthanized]2.9%169 reports
  5. Fever2.7%157 reports
  6. Ineffective, reversal[legacy FDA term: the product did not have the expected effect (reversal)]2.7%153 reports
  7. Hypothermia[low body temperature]2.6%151 reports
  8. Vocalisation[crying out or unusual noise]2.4%137 reports
  9. Recovery prolonged2.3%134 reports
  10. Overdose[more than the labelled amount was given]2.3%132 reports
  11. Ataxia[unsteady, uncoordinated movement]2.3%130 reports
  12. Cyanosis[bluish gums or skin from low oxygen]2.3%129 reports
  13. Panting2.2%128 reports
  14. Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]2.2%127 reports
  15. Abnormal radiograph finding2.2%126 reports
  16. Depression[dull, quiet or withdrawn]1.9%111 reports

The list shows 30 of 1,371 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog69%3,957
  • Cat25%1,434
  • Human exposure0.9%54
  • Rabbit0.3%15
  • Other Mammals0.2%14
  • Rat0.1%7

The share is of all 5,731 reports that name dexmedetomidine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog1,107 reports. Largest count in one month: 43 (Jun 2025)
Cat318 reports. Largest count in one month: 21 (Apr 2025)
Horse3 reports

No chart: no month has 5 or more reports.

Other or not given116 reports. Largest count in one month: 8 (Apr 2025)

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name dexmedetomidine hydrochloride, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
2026893519134
2025321109133464
202423555020310
202318145022248
202219043118252
202116458030252
202017247120240
201917068117256
201819353019265
201725083023356
201630891027426
20151939108292
201419287011290
20131909303286
201222282019323
2011210111114336
2010240102016358
2009280115020415
20081506305218
2007730010

2026 has the reports that FDA received through Jun 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal31.3%1,793
  • Recovered with Sequela[recovered, with a lasting effect]0.1%3
  • Ongoing21%1,205
  • Died11.7%669
  • Euthanized2.3%133
  • Outcome Unknown11.3%646

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 5,731 reports that name dexmedetomidine hydrochloride.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue75.3%4,314
  • Lack of expected effectiveness10.4%595
  • Both safety and lack of expected effectiveness9.6%549
  • Manufacturing or product defect4.7%270
  • Other0.1%3

4,110 reports say if the event was serious. 45.2% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year12.6%724
  • 1 to 3 years17.5%1,004
  • 4 to 7 years21.4%1,229
  • 8 to 11 years16.2%929
  • 12 years and over7.4%426
  • Age not given24.8%1,419

Weight of the animal

  • Under 5 kg (11 lb)19.5%1,117
  • 5 to 9.9 kg (11 to 22 lb)16.6%953
  • 10 to 24.9 kg (22 to 55 lb)14.2%812
  • 25 to 44.9 kg (55 to 99 lb)20.3%1,164
  • 45 kg and over (99 lb and over)4.3%248
  • Weight not given25.1%1,437

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Intramuscular44.5%2,553
  • Intravenous18.7%1,069
  • Buccal4%232
  • Sublingual2%112
  • Oral1.7%99
  • Subcutaneous1.5%84

Each bar is on a scale of 0 to 100%.

Approved animal drugs with this active ingredient (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Brand names

  • Dexdomitor
  • Dexmedesed
  • Dexvetra
  • DexmedVet

What the Green Book records give

Applications with an approval in force
6
Approved species
Cats, Dogs
Dose forms
Injectable Solution, Sterile Injectable Solution, Liquid (Solution), Sterile Solution
Routes
Intramuscular, Intravenous
Sale
RX (prescription)
Earliest approval date in the records

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
DexdomitorDexmedetomidine hydrochlorideOrion Corp.Dogs, CatsNADA 141-267
DexmedesedDexmedetomidine hydrochlorideDechra Veterinary Products LLCDogs, CatsANADA 200-573
DexvetraDexmedetomidine hydrochlorideParnell Technologies Pty. Ltd.Dogs, CatsANADA 200-699
Dexmedetomidine HydrochlorideDexmedetomidine hydrochlorideZyVet Animal Health, Inc.Dogs, CatsANADA 200-735
DexmedVetDexmedetomidine hydrochlorideCronus Pharma Specialities India Private Ltd.Dogs, CatsANADA 200-752
Dexmedetomidine HydrochlorideDexmedetomidine hydrochlorideFelix Pharmaceuticals Pvt. Ltd.Dogs, CatsANADA 200-824

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

The site checked these addresses on . The links open in a new tab.

Cite this page

Pet Drug Reports. Dexmedetomidine hydrochloride: adverse event reports that FDA received. https://petdrugreports.com/drug/dexmedetomidine-hydrochloride/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

How embedding works. It is free. Keep the link in the card and the link line under it.

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book section of this page lists the brand names with this active ingredient.

Do the reports show that the drug caused the signs?

No. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received 334 reports in the 12 months to June 2026. It received 394 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 5,731 reports received from September 2007 to June 2026, 75.3% are about a safety issue only. 20% are about a lack of expected effectiveness, alone or with a safety issue. 4.7% are about a defect of the product or its package.