Butorphanol Tartrate + Dexmedetomidine + Ketamine Hydrochloride: adverse event reports that FDA received

Name: Butorphanol Tartrate + Dexmedetomidine + Ketamine Hydrochloride: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

Combination of 3 active ingredients

The Green Book lists no brand name for exactly these active ingredients.

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 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

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

Contacting a veterinarian How to report to FDA

From October 2012 to June 2026, FDA received 131 adverse event reports that name this drug. Its active ingredients are butorphanol tartrate, dexmedetomidine and ketamine hydrochloride. Of the 131 reports, 128 (97.7%) are about cats. 3 reports are about dogs (2.3%).

In January to March 2026, FDA received 5 reports that name this drug. The signs that appear in the largest number of the 131 reports are "Behavioural disorder NOS" and "Hyperactivity". A report is not proof that a drug caused a sign.

Reports that name this drug fell by 50.0% 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 97.7% of the reports that name this drug, and 11% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on 11 Oct 2026, changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 5 reports that name butorphanol tartrate + dexmedetomidine + ketamine hydrochloride: 0 dog, 5 cat, 0 horse, 0 other or not given.

All updates Feed 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 131 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.

Behavioural disorder NOS[behaviour change, type not specified]16.8%22 reports
Hyperactivity14.5%19 reports
Dilated pupils13%17 reports
Not eating13%17 reports
Dysphoria11.5%15 reports
Lethargy[unusually tired or inactive]11.5%15 reports
Elevated temperature9.2%12 reports
Hiding7.6%10 reports
Not sleeping7.6%10 reports
Vocalisation[crying out or unusual noise]7.6%10 reports
Anorexia[not eating]6.9%9 reports
Application site alopecia[hair loss where the product was applied]6.9%9 reports
Death6.9%9 reports
Aggression6.1%8 reports

Show the next 16 signs

Dehydration6.1%8 reports
Seizure NOS[seizure, type not specified]6.1%8 reports
Weight loss6.1%8 reports
Death by euthanasia[the animal was euthanized]5.3%7 reports
Fever5.3%7 reports
Hyperthermia[raised body temperature]5.3%7 reports
Lateral recumbency[lying on the side, unable to rise]5.3%7 reports
Not drinking5.3%7 reports
Elevated blood urea nitrogen (BUN)[a kidney value above the normal range]4.6%6 reports
Elevated creatinine[a kidney value above the normal range]4.6%6 reports
Hyperphosphataemia[high blood phosphate]4.6%6 reports
Hyperproteinaemia[high blood protein]4.6%6 reports
Pacing4.6%6 reports
Twitching4.6%6 reports
Vomiting4.6%6 reports
Elevated globulins3.8%5 reports

The list shows 30 of 247 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Cat97.7%128
Dog2.3%3

The share is of all 131 reports that name butorphanol tartrate + dexmedetomidine + ketamine hydrochloride. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog3 reports

No chart: no month has 5 or more reports.

Cat124 reports. Largest count in one month: 8 (Dec 2022)

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given0 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 butorphanol tartrate + dexmedetomidine + ketamine hydrochloride, by the year in which FDA received them and by species
Year	Dog	Cat	All species
2026	0	11	11
2025	1	24	25
2024	0	30	30
2023	0	47	47
2022	2	12	14
2018	0	1	1
2017	0	1	1
2013	0	1	1
2012	0	1	1

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/Normal30.5%40
Recovered with Sequela[recovered, with a lasting effect]0%0
Ongoing30.5%40
Died7.6%10
Euthanized5.3%7
Outcome Unknown26%34

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 131 reports that name butorphanol tartrate + dexmedetomidine + ketamine hydrochloride.

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

Kind of report

Safety issue94.7%124
Lack of expected effectiveness3.8%5
Both safety and lack of expected effectiveness0%0
Manufacturing or product defect1.5%2
Other0%0

131 reports say if the event was serious. 33.6% 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 year27.5%36
1 to 3 years16.8%22
4 to 7 years20.6%27
8 to 11 years18.3%24
12 years and over13%17
Age not given3.8%5

Weight of the animal

Under 5 kg (11 lb)56.5%74
5 to 9.9 kg (11 to 22 lb)32.8%43
10 to 24.9 kg (22 to 55 lb)1.5%2
25 to 44.9 kg (55 to 99 lb)0%0
45 kg and over (99 lb and over)0%0
Weight not given9.2%12

Breed, where the report gives one breed

Domestic Shorthair65.6%86
Domestic Longhair8.4%11
Domestic Mediumhair6.1%8
Siamese3.8%5
Bengal0.8%1
Bombay0.8%1
British cat0.8%1
Domestic0.8%1

A breed with many animals has many reports.

Route in the report

Parenteral20.6%27
Intramuscular8.4%11
Intravenous0.8%1
Other0.8%1

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

Approved animal drugs with these active ingredients (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.

The Green Book lists no approved animal drug with these active ingredients. FDA also receives reports for human drugs and compounded drugs that veterinarians prescribe.

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Pet Drug Reports. Butorphanol Tartrate + Dexmedetomidine + Ketamine Hydrochloride: adverse event reports that FDA received. https://petdrugreports.com/drug/butorphanol-tartrate-dexmedetomidine-ketamine-hydrochloride/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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 lists no brand name for exactly these active ingredients.
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 16 reports in the 12 months to June 2026. It received 32 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 131 reports received from October 2012 to June 2026, 94.7% are about a safety issue only. 3.8% are about a lack of expected effectiveness, alone or with a safety issue. 1.5% are about a defect of the product or its package.