Numorphan Side Effects

Generic name: oxymorphone

Medically reviewed by Drugs.com. Last updated on Oct 21, 2024.

Note: This document provides detailed information about Numorphan Side Effects associated with oxymorphone. Some dosage forms listed on this page may not apply specifically to the brand name Numorphan.

Applies to oxymorphone: oral tablet, oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; tablet, extended release)

Addiction, Abuse, and Misuse. Oxymorphone 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 oxymorphone, and monitor all patients regularly for the development of these behaviors and conditions Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)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 REMS for these products.

Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

Healthcare providers are strongly encouraged to complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory Depression. Serious, life-threatening, or fatal respiratory depression may occur with use of oxymorphone.

Monitor for respiratory depression, especially during initiation of oxymorphone or following a dose increase Instruct patients to swallow oxymorphone extended-release (ER) tablets whole; crushing, chewing, or dissolving oxymorphone ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone.Accidental Ingestion. Accidental ingestion of even one dose of oxymorphone, especially by children, can result in a fatal overdose of oxymorphone.Neonatal Opioid Withdrawal Syndrome. Prolonged use of oxymorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interaction with Alcohol. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking oxymorphone.

The co-ingestion of alcohol with oxymorphone may result in increased plasma levels and a potentially 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 and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Oxymorphone may increase your risk of having serious breathing problems. Check with your doctor right away if you are having difficult or trouble breathing, irregular, fast, slow, or shallow breathing, or pale or blue lips, fingernails, or skin.

Using too much oxymorphone (the active ingredient contained in Numorphan) may cause an overdose, which can be life-threatening. Symptoms of an overdose include : change in consciousness, extreme dizziness or weakness, loss of consciousness, pale or blue lips, fingernails, or skin, slow heartbeat or breathing, seizures, trouble breathing, cold, clammy skin, sleepiness or unusual drowsiness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Oxymorphone may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oxymorphone.

If you have been using this medicine regularly for several weeks or more, do not change your dose or suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects (eg, anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping).

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby, which can be life-threatening. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking oxymorphone or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Numorphan

Some side effects of oxymorphone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• difficulty having a bowel movement
• feeling of constant movement of self or surroundings
• relaxed and calm
• sensation of spinning
• sleepiness

Less common side effects

• belching
• decreased weight
• discouragement
• excess air or gas in the stomach or bowels
• feeling of warmth
• feeling sad or empty
• full or bloated feeling
• heartburn
• indigestion
• lack of appetite
• loss of interest or pleasure
• passing gas
• pressure in the stomach
• redness of the face, neck, arms, and occasionally, upper chest
• stomach discomfort or upset
• swelling of the stomach area
• tiredness
• trouble concentrating

Rare side effects

• blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• difficulty with thinking or concentrating
• disturbed color perception
• double vision
• false or unusual sense of well-being
• feeling jittery
• halos around lights
• loss of vision
• night blindness
• nightmares or unusually vivid dreams
• overbright appearance of lights
• sudden sweating
• tunnel vision
• welts

Incidence not known

• forgetfulness
• loss of memory
• problems with memory

Serious side effects of Numorphan

Along with its needed effects, oxymorphone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking oxymorphone:

Less common side effects

• blurred vision
• confusion
• decreased urination
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, pounding, racing, or irregular heartbeat or pulse
• headache
• nervousness
• pounding in the ears
• rapid breathing
• sunken eyes
• sweating
• swelling of the hands, ankles, or feet
• thirst
• tightness in the chest
• unusual tiredness or weakness
• wrinkled skin

Rare side effects

• chest pain or discomfort
• chills
• cold sweats
• confusion about identity, place, and time
• cough
• decrease in consciousness
• deep or fast breathing with dizziness
• difficulty in passing urine (dribbling)
• difficulty with sleeping
• difficulty with swallowing
• drowsiness to profound loss of consciousness
• fever
• hives, itching, or skin rash
• hoarseness
• irregular, slow, or shallow breathing
• irritability
• irritation
• joint pain, stiffness, or swelling
• numbness of the feet, hands, and around the mouth
• painful urination
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• restlessness
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• stomach pain
• shaking
• trouble in holding or releasing urine
• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• agitation
• darkening of the skin
• diarrhea
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• mental depression
• nausea
• overactive reflexes
• poor coordination
• seizures
• shivering
• talking or acting with excitement you cannot control
• twitching
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking oxymorphone:

Symptoms of overdose

• change in consciousness
• cold and clammy skin
• constricted, pinpoint, or small pupils (black part of the eye)
• decreased awareness or responsiveness
• difficult or trouble breathing
• irregular, fast, slow, or shallow breathing
• loss of consciousness
• low blood pressure or pulse
• muscle weakness
• pale or blue lips, fingernails, or skin
• severe sleepiness or unusual drowsiness

For healthcare professionals

Applies to oxymorphone: injectable solution, oral tablet, oral tablet extended release, rectal suppository.

General adverse events

The most commonly reported adverse reactions included nausea, pyrexia, somnolence, vomiting, pruritus, headache, dizziness, constipation, and confusion. Additionally, the following adverse events were reported with the extended release tablet, diarrhea, insomnia, fatigue, decreased appetite and abdominal pain.^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (up to 26%), nausea (up to 33%), vomiting (up to 16%)
• Common (1% to 10%): Dry mouth, abdominal distention, flatulence, abdominal pain, diarrhea, dyspepsia
• Frequency not reported: Paralytic ileus, ileus
• Postmarketing reports: Difficulty swallowing tablets^[Ref]

Respiratory

• Common (1% to 10%): Hypoxia, dyspnea
• Frequency not reported: Respiratory depression, atelectasis, bronchospasm, decreased oxygen saturation, respiratory distress, respiratory rate decreased

laryngospasm, laryngeal edema, apnea^[Ref]

Nervous system

• Very common (10% or more): Somnolence (up to 19%), dizziness (excluding vertigo; up to 18%)
• Common (1% to 10%): Headache, confusion
• Frequency not reported: Sedation, CNS depression
• Postmarketing reports: Amnesia, convulsion, memory impairment^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity including dermatitis allergic, urticaria, pruritus, face swelling^[Ref]

Cardiovascular

• Common (1% to 10%): Tachycardia, hypotension, edema, flushing, hypertension
• Frequency not reported: Bradycardia, palpitations, orthostatic hypotension, syncope^[Ref]

Psychiatric

• Common (1% to 10%): Anxiety, insomnia, confusion, disorientation, restlessness, nervousness, depression
• Frequency not reported: Mental impairment, dysphoria, euphoric mood, agitation, hallucination, drug dependence, drug abuse, feeling jittery^[Ref]

Genitourinary

• Frequency not reported: Ureteral spasm, urinary hesitation, urinary retention, oliguria, difficult micturition^[Ref]

Dermatologic

• Very common (10% or more): Pruritus (up to 15%)
• Common (1% to 10%): Increased sweating
• Frequency not reported: Dermatitis^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite, dehydration, decreased weight
• Frequency not reported: Anorexia^[Ref]

Hepatic

• Frequency not reported: Biliary colic^[Ref]

Other

• Very common (10% or more): Pyrexia (14%)
• Frequency not reported: Fatigue, asthenia, hot flashes, clamminess, weakness^[Ref]

Ocular

• Common (1% to 10%): Vision blurred
• Frequency not reported: Miosis, diplopia, visual disturbances^[Ref]

Local

• Frequency not reported: Injection site reaction^[Ref]

See also:

Frequently asked questions

• Oxymorphone vs Hydromorphone - How do they compare?

Further information

Numorphan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer