Pet Drug Reports

Detomidine Hydrochloride (Dormosedan, DetomiSed)adverse event reports that FDA received

Active ingredient

Also sold as: Dormosedan, DetomiSed, Detomequin, Domidine.

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 March 1990 to June 2026, FDA received 1,304 adverse event reports that name a drug with detomidine hydrochloride as its active ingredient. Of the 1,304 reports, 1,056 (81%) are about horses. 58 reports are about dogs (4.4%).

In January to March 2026, FDA received 24 reports that name this drug. The signs that appear in the largest number of the 1,304 reports are "Ineffective, sedation", "Tachypnoea" and "Lack of efficacy - NOS". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 2.4% 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 horses are 81% of the reports that name this drug, and 1.4% of all reports.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 24 reports that name detomidine hydrochloride: 3 dog, 2 cat, 16 horse, 3 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 1,304 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)]18.6%243 reports
  2. Tachypnoea[fast breathing]7.9%103 reports
  3. Lack of efficacy - NOS[the product did not have the expected effect]7.7%100 reports
  4. Sedation prolonged7.4%96 reports
  5. Urticaria[hives]5.7%74 reports
  6. Accidental exposure[exposure that was not intended]5.1%66 reports
  7. Death5.1%66 reports
  8. Hives4.8%62 reports
  9. Ataxia[unsteady, uncoordinated movement]4.6%60 reports
  10. Underdose[less than the labelled amount was given]4.6%60 reports
  11. Anaphylaxis[sudden severe allergic-type reaction]4.2%55 reports
  12. Tachycardia[fast heart rate]4.1%54 reports
  13. Fever4.1%53 reports
  14. Collapse3.8%49 reports
Show the next 16 signs
  1. Death by euthanasia[the animal was euthanized]3.4%44 reports
  2. Hyperhidrosis3.3%43 reports
  3. Recumbency[lying down and unable or unwilling to rise]3.1%40 reports
  4. Bradycardia[slow heart rate]3%39 reports
  5. Colic3%39 reports
  6. Dyspnoea[difficulty breathing]2.7%35 reports
  7. Behavioural disorder NOS[behaviour change, type not specified]2.5%32 reports
  8. Lethargy[unusually tired or inactive]2.4%31 reports
  9. Facial oedema[swollen face]2.1%28 reports
  10. Pale mucous membrane[pale gums]2%26 reports
  11. Sedation1.9%25 reports
  12. Seizure NOS[seizure, type not specified]1.9%25 reports
  13. Trembling1.9%25 reports
  14. Unclassifiable adverse event[event that fits no dictionary term]1.9%25 reports
  15. Collapse NOS[NOS: not otherwise specified]1.8%23 reports
  16. Depression[dull, quiet or withdrawn]1.8%23 reports

The list shows 30 of 643 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

The share is of all 1,304 reports that name detomidine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog11 reports

No chart: no month has 5 or more reports.

Cat5 reports

No chart: no month has 5 or more reports.

Horse274 reports. Largest count in one month: 16 (Apr 2026)
Other or not given42 reports

No chart: no month has 5 or more reports.

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 detomidine hydrochloride, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20263243553
202532461061
202411651077
20232039849
20222048454
202110451763
20203060871
20192048454
20180043851
20172043449
20163033440
20151036643
20141135744
20133136646
20122142853
20112054460
20102032438
20090133539
20080016319
20071121225
20060128332
20052020527
20040022123
20030014216
20021011517
20015112321
20007120533
19992118728
19980011617
199730148
19962016422
199500011
19941013216
19931016118
19920012012
199100808
19900016016

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/Normal37.4%488
  • Recovered with Sequela[recovered, with a lasting effect]0.2%3
  • Ongoing4.9%64
  • Died7%91
  • Euthanized3.1%41
  • Outcome Unknown10%130

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 1,304 reports that name detomidine hydrochloride.

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

Kind of report

  • Safety issue77%1,004
  • Lack of expected effectiveness11.2%146
  • Both safety and lack of expected effectiveness5.2%68
  • Manufacturing or product defect6.4%84
  • Other0.2%2

738 reports say if the event was serious. 51.9% 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 year1.8%23
  • 1 to 3 years10.1%132
  • 4 to 7 years11%143
  • 8 to 11 years11.4%149
  • 12 years and over30.9%403
  • Age not given34.8%454

Weight of the animal

  • Under 5 kg (11 lb)0.8%10
  • 5 to 9.9 kg (11 to 22 lb)0.7%9
  • 10 to 24.9 kg (22 to 55 lb)1.7%22
  • 25 to 44.9 kg (55 to 99 lb)1.6%21
  • 45 kg and over (99 lb and over)49.6%647
  • Weight not given45.6%595

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Intravenous58.2%759
  • Sublingual8.3%108
  • Oral6.3%82
  • Intramuscular5.7%74
  • Other1.1%14
  • Subcutaneous0.9%12

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

  • Dormosedan
  • DetomiSed
  • Detomequin
  • Domidine

What the Green Book records give

Applications with an approval in force
5
Approved species
Horses, Equids
Dose forms
Injectable Solution, Gel, Liquid (Solution), Sterile Injectable Solution
Routes
Intramuscular, Intravenous, Oral
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
DormosedanDetomidine HydrochlorideOrion Corp.HorsesNADA 140-862
Dormosedan GelDetomidine HydrochlorideOrion Corp.HorsesNADA 141-306
DetomiSedDetomidine HydrochlorideCronus Pharma Specialities India Private Ltd.HorsesANADA 200-611
DetomequinDetomidine HydrochlorideModern Veterinary Therapeutics, LLCHorsesANADA 200-674
DomidineDetomidine HydrochlorideDechra Veterinary Products LLCHorsesANADA 200-846

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

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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 80 reports in the 12 months to June 2026. It received 82 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 1,304 reports received from March 1990 to June 2026, 77% are about a safety issue only. 16.4% are about a lack of expected effectiveness, alone or with a safety issue. 6.4% are about a defect of the product or its package.