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.
- Torbugesic ® (butorphanol tartrate injection), Zoetis Inc.. Set id f05b503c-135a-4884-9c89-53f14946f3e0.
- Covetrus Butorphanol Tartrate Injection CIV, Covetrus. Set id 10519e66-0186-40cd-987b-2f27301d6e46.
- Butorphanol CIV (butorphanol tartrate) Injection, ASPEN VETERINARY RESOURCES®, LTD. Set id 654caaed-f7bd-4f07-8d82-9bccf8b91205.
- Butorphic ® CIV (butorphanol tartrate injection), Cronus Pharma LLC. Set id 1c483aea-be01-4db5-9fac-c1d224a335e1.
- VET One Vetorphic TM CIV (butorphanol tartrate injection) Injection, MWI Animal Health. Set id 69ef8de1-605b-4155-8d17-1b34dd0d15e0.
- DOLOREX ® (butorphanol tartrate injection) CIV, Schering Corporation. Set id 3c274f98-94db-4674-ac28-69d683db4842.
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
| VeDDRA reaction term | Reports |
|---|---|
| Vomiting | 576 |
| Lack of efficacy - NOS | 537 |
| Death | 449 |
| Diarrhoea | 368 |
| Bradycardia | 350 |
| Lethargy (see also Central nervous system depression in 'Neurological') | 324 |
| Anorexia | 300 |
| Injection site swelling | 267 |
| Death by euthanasia | 242 |
| Seizure NOS | 241 |
| Lethargy (see also Central nervous system depression in Neurological) | 230 |
| Cardiac arrest | 219 |
| Not eating | 207 |
| Elevated alanine aminotransferase (ALT) | 195 |
| Pain NOS | 187 |
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
- Torphadine ® CIV (butorphanol tartrate injection)FDA · retrieved 2026-09-16
“The recommended dosage in the horse is 0.1 mg of butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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