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Medication Guide — Oxycontin

Patient-friendly FDA guidance and safety information.

Last updated · May 25, 2026Source: DailyMed ↗
Boxed Warning

Addiction, Abuse, and Misuse

Because the use of OXYCONTIN 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 .

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCONTIN, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OXYCONTIN are essential. Instruct patients to swallow OXYCONTIN tablets whole; crushing, chewing, or dissolving OXYCONTIN tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone .

Accidental Ingestion

Accidental ingestion of even one dose of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone .

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 OXYCONTIN and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate .

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 .

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 .

Cytochrome P450 3A4 Interaction

The concomitant use of OXYCONTIN with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects 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 OXYCONTIN and any CYP3A4 inhibitor or inducer .

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCONTIN

See full prescribing information for complete boxed warning.

  • OXYCONTIN 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.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of OXYCONTIN are essential. Instruct patients to swallow OXYCONTIN tablets whole to avoid exposure to a potentially fatal dose of oxycodone.
  • Accidental ingestion of OXYCONTIN, especially by children, can result in a fatal overdose of oxycodone.
  • 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)
  • 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 appropriate management by neonatology experts will be available at delivery.
  • 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.
  • Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (5.6, 7, 12.3)

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 05/2026

Medication Guide


OXYCONTIN® (ox-e-KON-tin) (oxycodone hydrochloride) extended-release tablets, CII

    OXYCONTIN is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain, that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not to be taken on an "as-needed" basis.
  • Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid.
    Important information about OXYCONTIN:
  • Get emergency help or call 911 right away if you take too much OXYCONTIN (overdose). When you first start taking OXYCONTIN, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
  • Taking OXYCONTIN with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your OXYCONTIN. They could die from taking it. Selling or giving away OXYCONTIN is against the law.
  • Store OXYCONTIN securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take OXYCONTIN if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking OXYCONTIN, tell your healthcare provider if you have a history of:

  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
    Tell your healthcare provider if you are:
  • noticing your pain getting worse. If your pain gets worse after you take OXYCONTIN, do not take more OXYCONTIN without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking OXYCONTIN.
  • pregnant or planning to become pregnant. Use of OXYCONTIN for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with OXYCONTIN. It may harm your baby.
  • living in a household where there are small children or someone who has abused street or prescription drugs. Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OXYCONTIN with certain other medicines can cause serious side effects that could lead to death.
    When taking OXYCONTIN:
  • Do not change your dose. Take OXYCONTIN exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
  • Swallow OXYCONTIN whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCONTIN because this may cause you to overdose and die.
  • OXYCONTIN should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking OXYCONTIN without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused OXYCONTIN by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
    While taking OXYCONTIN DO NOT:
  • Drive or operate heavy machinery until you know how OXYCONTIN affects you. OXYCONTIN can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol, or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with OXYCONTIN may cause you to overdose and die.
    The possible side effects of OXYCONTIN are:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
    Get emergency medical help or call 911 right away if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of OXYCONTIN. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For more information, go to dailymed.nlm.nih.gov

Manufactured by: Knoa Pharma LLC, Stamford, CT 06901-3431, www.knoapharma.com or call 1-888-726-7535

OXYCONTIN® CII
(OXYCODONE HCl) EXTENDED-RELEASE TABLETS

Sources

RxCUI: 1049595

NDC: 590110460

Last fetched: May 25, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.