Last reviewed 2026-04-20 · How we verify

BUTORPHANOL TARTRATE

Butorphanol Tartrate is a marketed drug primarily indicated for severe pain management, holding a established position in the analgesic market. Its key strength lies in its mechanism of action, which differentiates it from other analgesics, potentially offering unique efficacy and safety profiles. The primary risk to Butorphanol Tartrate is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Severe Pain Management

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BUTORPHANOL TARTRATE NASAL SPRAY Addiction, Abuse, and Misuse Because the use of butorphanol tartrate nasal spray exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see WARNINGS ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of butorphanol tartrate nasal spray, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of butorphanol tartrate nasal spray are essential [see WARNINGS ]. Accidental Exposure Accidental exposure of even one dose of butorphanol tartrate nasal spray, especially in children, can result in a fatal overdose of butorphanol tartrate[see WARNINGS ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of butorphanol tartrate nasal spray and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see WARNINGS , PRECAUTIONS ; Drug Interactions ]. Neonatal Opioid Withdrawal Syndrome If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see WARNINGS] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see WARNINGS ].

Common side effects

• somnolence
• dizziness
• nausea and/or vomiting
• nasal congestion
• insomnia

Key clinical trials

• Effects of Transversus Abdominis Plane Block on Recovery Quality and Maternal-Neonatal Outcomes After Cesarean Delivery (NA)
• EOIB for Pain After Laparoscopic Cholecystectomy (NA)
• Butorphanol for Pain Relief After Cesarean Section: A Retrospective Study
• Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia (NA)
• Esketamine and Butorphanol for Post-Lobectomy Pain (PHASE4)
• Butorphanol in Pain Following Ablation for Hepatic Tumor (NA)
• Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain (PHASE4)
• Efficacy and Safety of Butorphanol Tartrate Injection for the Patients With Mechanical Ventilation (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• BUTORPHANOL TARTRATE CI brief — competitive landscape report
• BUTORPHANOL TARTRATE updates RSS · CI watch RSS