Butorphanol Tartrate + Dexmedetomidine: adverse event reports that FDA received

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

Combination of 2 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 February 2012 to May 2026, FDA received 25 adverse event reports that name a drug with butorphanol tartrate and dexmedetomidine as its active ingredients. Of the 25 reports, 15 (60%) are about cats. 10 reports are about dogs (40%).

In January to March 2026, FDA received no reports that name this drug. The sign that appears in the largest number of the 25 reports is "Behavioural disorder NOS". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change.

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 0 reports that name butorphanol tartrate + dexmedetomidine: 0 dog, 0 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 25 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]20%5 reports
Death16%4 reports
Lethargy[unusually tired or inactive]16%4 reports
Anorexia[not eating]12%3 reports
Dysphoria12%3 reports
Lack of efficacy - NOS[the product did not have the expected effect]12%3 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]12%3 reports
Panting12%3 reports
Abdominal pain8%2 reports
Abnormal radiograph finding8%2 reports
Diarrhoea[diarrhea]8%2 reports
Dilated pupils8%2 reports
Emesis[vomiting]8%2 reports
Emesis (multiple)[vomiting more than once]8%2 reports

Show the next 16 signs

Hypothermia[low body temperature]8%2 reports
Intestinal perforation8%2 reports
Listless8%2 reports
Not drinking8%2 reports
Not eating8%2 reports
Peritonitis[inflamed abdominal lining]8%2 reports
Restlessness8%2 reports
Vocalisation[crying out or unusual noise]8%2 reports
Vomiting8%2 reports
Abdominal cavity haemorrhage4%1 reports
Abnormal ultrasound finding4%1 reports
Aerophagia4%1 reports
Aggression4%1 reports
Agitation4%1 reports
Apnoea[breathing stopped]4%1 reports
Application site scratching[scratching where the product was applied]4%1 reports

The list shows 30 of 106 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Cat60%15
Dog40%10

The share is of all 25 reports that name butorphanol tartrate + dexmedetomidine. 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.

Cat15 reports

No chart: no month has 5 or more reports.

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, by the year in which FDA received them and by species
Year	Dog	Cat	All species
2026	0	2	2
2025	0	3	3
2024	0	1	1
2023	0	5	5
2022	2	4	6
2021	2	0	2
2020	1	0	1
2014	2	0	2
2012	3	0	3

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

What the reports record

Outcome at the time of the report

Recovered/Normal40%10
Recovered with Sequela[recovered, with a lasting effect]0%0
Ongoing20%5
Died16%4
Euthanized4%1
Outcome Unknown20%5

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 25 reports that name butorphanol tartrate + dexmedetomidine.

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

Kind of report

Safety issue92%23
Lack of expected effectiveness4%1
Both safety and lack of expected effectiveness4%1
Manufacturing or product defect0%0
Other0%0

25 reports say if the event was serious. 56% 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 year36%9
1 to 3 years20%5
4 to 7 years16%4
8 to 11 years20%5
12 years and over4%1
Age not given4%1

Weight of the animal

Under 5 kg (11 lb)56%14
5 to 9.9 kg (11 to 22 lb)0%0
10 to 24.9 kg (22 to 55 lb)12%3
25 to 44.9 kg (55 to 99 lb)16%4
45 kg and over (99 lb and over)4%1
Weight not given12%3

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

Intramuscular16%4
Parenteral8%2
Intravenous4%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.

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: adverse event reports that FDA received. https://petdrugreports.com/drug/butorphanol-tartrate-dexmedetomidine/ 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 3 reports in the 12 months to June 2026. It received 2 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 25 reports received from February 2012 to May 2026, 92% are about a safety issue only. 8% are about a lack of expected effectiveness, alone or with a safety issue.