Butorphanol

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This page reprints a manufacturer label. Everything below in quotation marks is copied from Torphadine ® CIV (butorphanol tartrate injection), published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for Torphadine ® CIV (butorphanol tartrate injection) by Dechra Veterinary Products, a butorphanol product labelled for dogs. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed. 6 other stored labels carry the same active ingredient and are listed at the end.

The label

Product: Torphadine ® CIV (butorphanol tartrate injection). Manufacturer: Dechra Veterinary Products. FDA Structured Product Label set id 89fa35f1-61a2-425a-bf5f-c4e78ebfac20. Label effective 2025-12-16. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

TORPHADINE (butorphanol tartrate injection) is indicated for the relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that butorphanol tartrate injection alleviates abdominal pain associated with torsion, impaction, intussusception, spasmodic and tympanic colic and postpartum pain.

Dosage and Administration

The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL of TORPHADINE for each 1000 lbs body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Pre-clinical model studies and clinical field trials in horses demonstrate that the analgesic effects of butorphanol tartrate injection are seen within 15 minutes following injection and persist for about 4 hours. Use within 6 months of first puncture.

Warnings

DO NOT USE IN HORSES INTENDED FOR HUMAN CONSUMPTION. NOT FOR HUMAN USE.

Adverse Reactions

In clinical trials in horses, the most commonly observed side effect was slight ataxia which lasted 3 to 10 minutes. Marked ataxia was reported in 1.5% of the 327 horses treated. Mild sedation was reported in 9% of the horses. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet, contact Dechra Veterinary Products at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Description

TORPHADINE (butorphanol tartrate injection) is a totally synthetic, centrally acting, narcotic agonist-antagonist analgesic with potent antitussive activity. It is a member of the phenanthrene series. The chemical name is Morphinan-3, 14-diol, 17-(cyclobutylmethyl)-, (-)-, (S- (R*, R*))-2, 3-dihydroxybutanedioate (1:1) (salt). It is a white, crystalline, water soluble substance having a molecular weight of 477.55; its molecular formula is C 21 H 29 NO 2 ∙C 4 H 6 O 6 . Chemical Structure Each mL of TORPHADINE contains 10 mg butorphanol base (as butorphanol tartrate), 3.3 mg citric acid, 6.4 mg sodium citrate, 4.7 mg sodium chloride, and 0.1 mg benzethonium chloride, q.s. with water for injection. Chemical Structure

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming butorphanol as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 4,397 reports

Reactions most often coded in dogs, 4,397 reports
VeDDRA reaction termReports
Vomiting576
Lack of efficacy - NOS537
Death449
Diarrhoea368
Bradycardia350
Lethargy (see also Central nervous system depression in 'Neurological')324
Anorexia300
Injection site swelling267
Death by euthanasia242
Seizure NOS241
Lethargy (see also Central nervous system depression in Neurological)230
Cardiac arrest219
Not eating207
Elevated alanine aminotransferase (ALT)195
Pain NOS187

Outcome as recorded by the reporter: Recovered/Normal 1,556; Ongoing 1,004; Outcome Unknown 661; Died 521; Euthanized 236; Recovered with Sequela 17.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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