Last reviewed 2026-04-20 · How we verify

OxyContin (oxycodone)

At a glance

Approved indications

• Acute postoperative pain
• Chronic Pain with Opioid Tolerance
• Severe pain

Boxed warnings

• WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS Addiction, Abuse, and Misuse Because the use of oxycodone hydrochloride 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 and Precautions (5.1)] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride tablets are essential [see Warnings and Precautions (5.2)] . Accidental Ingestion Accidental ingestion of even one dose of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)] . 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 oxycodone hydrochloride 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) Advise pregnant women using opioids for an extended period of time 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 [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)] . Cytochrome P450 3A4 Interaction The concomitant use of oxycodone hydrochloride tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving oxycodone hydrochloride tablets and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6), Drug Interactions (7), Clinical Pharmacology (12.3)] . WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS See full prescribing information for complete boxed warning. Oxycodone hydrochloride tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride tablets are essential. (5.2) Accidental ingestion of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone. (5.2) 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; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.3, 7) Advise pregnant women using opioids for an extended period of time 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) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone from oxycodone hydrochloride tablets. (5.6, 7, 12.3)

Common side effects

• nausea
• constipation
• vomiting
• headache
• pruritus
• insomnia
• dizziness
• asthenia
• somnolence

Key clinical trials

• Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study) (Phase 4)
• Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department (NA)
• Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery (Phase 4)
• A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain. (Phase 3)
• No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair (Phase 4)
• Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial (EARLY/Phase 1)
• Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System (Phase 1)
• Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial (NA)

Patents

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:

• OxyContin CI brief — competitive landscape report
• OxyContin updates RSS · CI watch RSS
• Purdue Pharma portfolio CI