Naloxone / Oxycodone Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 5, 2024.

Applies to naloxone / oxycodone: oral tablet extended release.

Important warnings This medicine can cause some serious health issues

You should not use this medicine if you have severe asthma or breathing problems, severe liver disease, or a blockage in your stomach or intestines.

This medicine can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share naloxone and oxycodone medicine with another person.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Oxycodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Some medicines can interact with naloxone and oxycodone, and cause dangerous side effects or death. Tell your doctor about all your current medicines and any you start or stop using.

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

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat, cold, clammy skin;

• seizure (convulsions);

• confusion, severe drowsiness;

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

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

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

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Naloxone and oxycodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

• drowsiness, headache, dizziness;

• stomach pain, nausea, constipation;

• anxiety; or

• sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to naloxone / oxycodone: oral tablet extended release.

Cardiovascular adverse events

• Common (1% to 10%): Hypertension, hypotension
• Uncommon (0.1% to 1%): Angina pectoris, (especially in patients with history of coronary artery disease), palpitations, peripheral edema, chest pain
• Rare (less than 0.1%): Syncope
• Frequency not reported: Flushing, bradycardia, ST depression, supraventricular tachycardia^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus, rash, cold sweat
• Postmarketing reports: Hyperhidrosis, exfoliative dermatitis, dry skin, urticaria^[Ref]

Endocrine

• Common (1% to 10%): Hot flush^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, abdominal pain, dry mouth, flatulence, vomiting, nausea, anorexia, increased appetite, gastroenteritis, dyspepsia, constipation
• Frequency not reported: Thirst, eructation, colic, dysphagia, stomatitis, taste perversion, dental caries, ileus, flatulence^[Ref]

Genitourinary

• Frequency not reported: Urinary tract infection, micturition urgency, ureteric spasm, erectile dysfunction, urinary retention, amenorrhea^[Ref]

Hepatic

• Frequency not reported: Biliary colic, increased liver enzymes, biliary spasm, cholestasis^[Ref]

Hypersensitivity

• Rare (less than 0.1%): Allergic reactions, anaphylactic reactions^[Ref]

Immunologic

• Common (1% to 10%): Influenza
• Rare (less than 0.1%): Herpes simplex
• Frequency not reported: Lymphadenopathy^[Ref]

Metabolic

• Common (1% to 10%): Loss of appetite
• Rare (less than 0.1%): Dehydration, increased appetite
• Frequency not reported: Increased serum triglycerides, hyponatremia^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, fall, arthralgia, myalgia
• Frequency not reported: Myalgia, neck pain, striated and nonstriated muscle spasms, muscle twitching, muscle rigidity, osteoarthritis, abnormal gait, hypertonia, involuntary muscle contractions, abnormal coordination^[Ref]

Nervous system

• Common (1% to 10%): Headache, fatigue, dizziness, drug withdrawal syndrome, sedation, tremor, sinus headache, somnolence
• Uncommon (0.1% to 1%): Disturbance in attention, paraesthesia, speech disorder, malaise
• Rare (less than 0.1%): Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions)
• Frequency not reported: Syncope
• Postmarketing reports: Raised intracranial pressure, sciatica, tremor, vertigo, drowsiness, paraesthesia, somnolence, speech disorder, amnesia, hypertonia, migraine, feeling hot and cold, chills, tinnitus^[Ref]

Ocular

• Common (1% to 10%): Lacrimation increased
• Uncommon (0.1% to 1%): Visual disturbances, miosis^[Ref]

Oncologic

• Common (1% to 10%): Malignant neoplasm progression

Psychiatric

• Common (1% to 10%): Drug abuse, anxiety, restlessness
• Uncommon (0.1% to 1%): Abnormal thinking, confusion, depression, hallucination, altered mood, personality change, euphoric mood, decreased activity, psychomotor hyperactivity, agitation, nervousness, insomnia, perception disturbances (e.g., hallucination, derealization), reduced libido, mood changes, disorientation, dysphoria, nightmares^[Ref]

Respiratory

• Common (1% to 10%): Dyspnea, rhinorrhea, yawning
• Uncommon (0.1% to 1%): Respiratory depression, bronchial spasm, spasms of nonstriated muscles, suppression of the cough reflex
• Frequency not reported: Bronchitis, nasopharyngitis, pharyngitis, voice alteration, sinusitis, lower respiratory tract infection, hiccup^[Ref]

Further information

Naloxone/oxycodone 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer