Oxymorphone is an opioid medicine that is used to treat moderate to severe pain.

The extended-release form of oxymorphone is for around-the-clock treatment of pain and should not be used on an as-needed basis for pain.

Oxymorphone may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Oxymorphone comes as a tablet and as an extended-release (long-acting) tablet to take by mouth on an empty stomach, at least 1 hour before or 2 hours after meals. It is usually taken every 4 to 6 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxymorphone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not chew or crush them.

Your doctor will probably start you on a low dose of oxymorphone and gradually increase your dose until your pain is controlled. Your doctor may adjust your dose at any time during your treatment if your pain is not controlled. If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.

Do not stop taking oxymorphone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking oxymorphone, you may experience withdrawal symptoms such as restlessness; watery eyes; runny nose; yawning; sweating; chills; muscle, joint, or back pain; enlarged pupils (black circles in the centers of the eyes); irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; vomiting; diarrhea; loss of appetite; fast heartbeat; and fast breathing.

Follow the directions on your prescription label and read all medication guides. Never use oxymorphone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of oxymorphone.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Stop using all other around-the-clock opioid pain medications when you start taking oxymorphone.

Take oxymorphone on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take the medicine at the same times each day.

Swallow the tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, or dissolve.

Take only one extended-release tablet at a time. To avoid choking, do not lick or wet the tablet before placing it in your mouth.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

You may have withdrawal symptoms if you stop using oxymorphone suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not take oxymorphone if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• severe liver disease; or

• a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing that stops during sleep);

• a head injury or seizures;

• drug or alcohol addiction, or mental illness;

• urination problems;

• liver or kidney problems; or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since oxymorphone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how oxymorphone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Oxymorphone may cause serious side effects. Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops;

• a light-headed feeling, like you might pass out;

• seizure (convulsions);

• chest pain, wheezing, cough with yellow or green mucus;

• severe vomiting;

• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of oxymorphone may include:

• dizziness, drowsiness;

• headache, tiredness; or

• stomach pain, nausea, vomiting, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many drugs may affect oxymorphone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor.

This prescription is not refillable. If you are taking oxymorphone to control your pain on a long term basis, be sure to schedule appointments with your doctor regularly so that you do not run out of medication. If you are taking oxymorphone on a short term basis, call your doctor if you continue to have pain after you finish the medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.