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Medication Guide — OXYMORPHONE HYDROCHLORIDE

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗
Boxed Warning

Addiction, Abuse, and Misuse
Because the use of oxymorphone 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 .

Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of oxymorphone hydrochloride tablets, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of oxymorphone hydrochloride tablets are essential .

Accidental Ingestion
Accidental ingestion of even one dose of oxymorphone hydrochloride tablets, especially by children, can result in a fatal overdose of oxymorphone .

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 oxymorphone hydrochloride tablets 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 .

Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking oxymorphone hydrochloride tablets. The co-ingestion of alcohol with oxymorphone hydrochloride tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone .

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS See full prescribing information for complete boxed warning.

  • Oxymorphone 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 monitor regularly for these behaviors and conditions.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
  • Accidental ingestion of oxymorphone hydrochloride tablets, especially by children, can result in a fatal overdose of oxymorphone.
  • 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.
  • To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
  • Instruct patients not to consume alcohol or any product containing alcohol while taking oxymorphone hydrochloride tablets because co-ingestion can result in fatal plasma oxymorphone levels.

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.

On this page

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                       Revised: 08/2025

                                                                                       Medication Guide

                                                   Oxymorphone hydrochloride (OX-i-MOR-fone HYE-droe-KLOR-ide) tablets,

                                                                                       for oral use, CII

Oxymorphone hydrochloride tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An 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.

Important information about oxymorphone hydrochloride tablets:

  • Get emergency help or call 911 right away if you take too much oxymorphone hydrochloride tablets (overdose). When you first start taking oxymorphone hydrochloride tablets, 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 oxymorphone hydrochloride tablets 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 oxymorphone hydrochloride tablets. They could die from taking it. Selling or giving away oxymorphone hydrochloride tablets is against the law.
  • Store oxymorphone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take oxymorphone hydrochloride tablets if you have:

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

Before taking oxymorphone hydrochloride tablets, tell your healthcare provider if you have a history of:

  • head injury, seizures      • liver, kidney, thyroid problems
  • problems urinating         • 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 oxymorphone hydrochloride tablets, do not take more of oxymorphone hydrochloride tablets 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 oxymorphone hydrochloride tablets.
  • Are pregnant or planning to become pregnant. Use of oxymorphone hydrochloride tablets 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. Oxymorphone hydrochloride tablets passes into breast milk and 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 oxymorphone hydrochloride tablets with certain other medicines can cause serious side effects that could lead to death.

When taking oxymorphone hydrochloride tablets:

  • Do not change your dose. Take oxymorphone hydrochloride tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • For acute (short-term) pain, you may only need to take oxymorphone hydrochloride tablets for a few days. You may have some oxymorphone hydrochloride tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused oxymorphone hydrochloride tablets.
  • Oxymorphone hydrochloride tablets should be taken on an empty stomach, at least one hour prior to or two hours after eating.
  • Take your prescribed dose at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking oxymorphone hydrochloride tablets regularly, do not stop taking oxymorphone hydrochloride tablets without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused oxymorphone hydrochloride tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of oxymorphone hydrochloride tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking oxymorphone hydrochloride tablets DO NOT:

  • Drive or operate heavy machinery, until you know how oxymorphone hydrochloride tablets affects you. Oxymorphone hydrochloride tablets 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 oxymorphone hydrochloride tablets may cause you to overdose and die.

The possible side effects of oxymorphone hydrochloride tablets:

  • 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 or hands, hives, itching, rash, 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 oxymorphone hydrochloride tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or call Camber Pharmaceuticals, Inc. at 1-866-495-8330. For more information go to dailymed.nlm.nih.gov

Medication Guide available at http://camberpharma.com/medication-guides

Manufactured by:

Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

Sources

RxCUI: 977939

NDC: 31722-929

Last fetched: May 13, 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.