Last reviewed 2026-04-20 · How we verify

PENTAZOCINE HYDROCHLORIDE

Pentazocine Hydrochloride is a marketed drug primarily indicated for severe pain management, with a key composition patent expiring in 2028. Its market position is bolstered by its established use in pain management, though specific revenue figures are not provided. The primary risk is the patent expiry in 2028, which could lead to increased competition from generic versions.

At a glance

Approved indications

• Severe Pain Management

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF PENTAZOCINE AND NALOXONE TABLETS Addiction, Abuse, and Misuse Because the use of Pentazocine and Naloxone Tablets 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 Pentazocine and Naloxone Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Pentazocine and Naloxone Tablets are essential [ see <WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Pentazocine and Naloxone Tablets, especially by children, can result in a fatal overdose of Pentazocine Hydrochloride [ 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 Pentazocine and Naloxone Tablets 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 (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be lifethreatening 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

• Nausea
• Vomiting
• Constipation
• Dizziness
• Lightheadedness
• Hallucinations
• Sedation
• Euphoria
• Headache
• Confusion
• Disorientation
• Sweating

Serious adverse events

• Anaphylactic shock
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Agranulocytosis
• Respiratory depression
• Grand mal convulsions
• Syncope
• Opioid-induced esophageal dysfunction
• Erythema multiforme
• Biliary tract spasm

Drug interactions

• benzodiazepines and other CNS depressants
• serotonergic drugs (SSRIs, SNRIs, TCAs, triptans, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAO inhibitors)
• monoamine oxidase inhibitors (MAOIs)
• mixed agonist/antagonist and partial agonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine)
• muscle relaxants

Key clinical trials

• Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial (PHASE4)
• Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia (NA)
• Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section (NA)
• Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration (PHASE4)
• Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (PHASE1, PHASE2)
• Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section (NA)
• Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients (NA)
• Effects of Pentazocine Versus Lorazepam on Manic Symptoms (PHASE2)

Primary sources

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Competitive intelligence

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

• PENTAZOCINE HYDROCHLORIDE CI brief — competitive landscape report
• PENTAZOCINE HYDROCHLORIDE updates RSS · CI watch RSS