Last reviewed 2026-04-20 · How we verify

Nucynta (TAPENTADOL)

Nucynta works by binding to opioid receptors in the brain to reduce the perception of pain.

At a glance

Mechanism of action

Tapentadol is centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is mu-opioid receptor (MOR) agonist and norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.

Approved indications

• Pain

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TAPENTADOL EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of tapentadol extended-release tablets expose 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 and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of tapentadol extended-release tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol extended-release tablets are essential. Instruct patients to swallow tapentadol extended-release tablets whole; crushing, chewing, or dissolving tapentadol extended-release tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol [see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of tapentadol extended-release tablets, especially by children, can result in a fatal overdose of tapentadol [see Warnings and Precautions (5.2) ] . Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking tapentadol extended-release tablets. The co-ingestion of alcohol with tapentadol extended-release tablets may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol [see Warnings and Precautions (5.2 , 5.3) ] . 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 tapentadol extended-release tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) 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 and Precautions (5.4) ] . 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 and Precautions (5.5) ] . WARNING: SERIOUS LIFE-THREATENING RISKS FROM USE OF TAPENTADOL extended-release tablet See full prescribing information for complete boxed warning . Tapentadol extended-release tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and reassess regularly for development of these behaviors or conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tapentadol extended-release tablets are essential. Instruct patients to swallow tapentadol extended-release tablets whole to avoid exposure to a potentially fatal dose of tapentadol. ( 2.1 , 5.2 ) Accidental ingestion of tapentadol extended-release tablets, especially in children, can result in fatal overdose of tapentadol. ( 5.2 ) Instruct patients not to consume alcohol or any products containing alcohol while taking tapentadol extended-release tablets because co-ingestion can result in fatal plasma tapentadol levels. ( 5.3 ) 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 for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) 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. ( 5.5 )

Common side effects

• Nausea
• Dizziness
• Vomiting
• Somnolence
• Constipation
• Fatigue
• Headache
• Pruritus
• Decreased appetite
• Dyspepsia
• Nasopharyngitis
• Upper respiratory tract infection

Drug interactions

• cyclobenzaprine
• doxepin
• maprotiline
• trimipramine
• venlafaxine
• zolmitriptan

Key clinical trials

• Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (NA)
• OpioidRedoxStudyII
• Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients. (NA)
• ACU_Knee: Role of Acupuncture in Knee Prosthetic Surgery (NA)
• IV vs Oral Acetaminophen in Spine Fusion Perioperative Care (PHASE4)
• Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain (PHASE4)
• Tapentadol vs Tramadol in Total Knee Arthroplasty (PHASE4)
• Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients

Patents

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:

• Nucynta CI brief — competitive landscape report
• Nucynta updates RSS · CI watch RSS
• Collegium Pharm Inc portfolio CI