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Naltrexone / oxycodone Side Effects

For the Consumer

Applies to naltrexone / oxycodone: oral capsule extended release

As well as its needed effects, naltrexone / oxycodone may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking naltrexone / oxycodone, check with your doctor immediately:

Less common:
  • Fast, pounding, or irregular heartbeat or pulse
  • fever
  • hives, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • pale skin
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • troubled breathing or swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known:
  • Abdominal or stomach pain
  • agitation
  • blurred vision
  • confusion
  • cough
  • diarrhea
  • dizziness or fainting
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • headache
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • nausea with or without vomiting
  • overactive reflexes
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • restlessness
  • seizures
  • shivering
  • sweating
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching

Minor Side Effects

Some naltrexone / oxycodone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Back pain
  • difficulty having a bowel movement (stool)
  • sleepiness or unusual drowsiness
  • trouble sleeping
Less common:
  • Acid or sour stomach
  • belching
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • decreased appetite
  • difficulty with moving
  • dry mouth
  • feeling of warmth
  • heartburn
  • indigestion
  • muscle pain or stiffness
  • muscle spasms
  • pain in the joints
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • stomach discomfort or upset
  • sudden sweating
  • tingling of the hands or feet
  • unusual weight gain or loss

For Healthcare Professionals

Applies to naltrexone / oxycodone: oral capsule extended release

General

The most frequently reported adverse effects have included nausea, constipation, vomiting, headache, and somnolence.[Ref]

Respiratory

Rhinorrhea, chronic bronchitis, dyspnea, and dysphonia were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Oropharyngeal pain, cough
Frequency not reported: Rhinorrhea, chronic bronchitis, dyspnea, dysphonia[Ref]

Gastrointestinal

Dyspepsia was reported in less than 2% of patients.[Ref]

Very common (10% or more): Nausea (up to 20.5%), constipation (up to 14.9%)
Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, nausea
Frequency not reported: Dyspepsia[Ref]

Hypersensitivity

Drug hypersensitivity was reported in less than 2% of patients. Anaphylaxis and pharyngeal edema have been reported with ingredients contained in this drug.[Ref]

Frequency not reported: Drug hypersensitivity
Postmarketing reports: Anaphylaxis, pharyngeal edema[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema
Frequency not reported: Tachycardia, palpitations, bradycardia, chest pain, increased blood pressure
Postmarketing reports: Myocardial ischemia, ventricular fibrillation (with oxycodone overdose)[Ref]

Tachycardia, palpitations, bradycardia, chest pain, and increased blood pressure were reported in less than 2% of patients.[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression, restlessness
Frequency not reported: Irritability, abnormal dreams, confusional state, disorientation, decreased libido, drug abuse[Ref]

Irritability, abnormal dreams, confusional state, disorientation, decreased libido, and drug abuse were reported in less than 2% of patients.[Ref]

Nervous system

Postmarketing reports of serotonin syndrome have been received among patients with concomitant use of opioids and serotonergic drugs.[Ref]

Common (1% to 10%): Dizziness, headache, hypoesthesia, somnolence, tremor
Postmarketing reports: Serotonin syndrome[Ref]

Dermatologic

Rash and urticaria were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Hyperhidrosis, pruritus
Frequency not reported: Rash, urticaria[Ref]

Endocrine

Decreased blood testosterone was reported in less than 2% of patients.[Ref]

Frequency not reported: Decreased blood testosterone
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Genitourinary

Frequency not reported: Dysuria, hematuria[Ref]

Dysuria and hematuria were reported in less than 2% of patients.[Ref]

Hematologic

Anemia and lymphadenopathy were reported in less than 2% of patients.[Ref]

Frequency not reported: Anemia, lymphadenopathy[Ref]

Hepatic

Frequency not reported: Abnormal liver function test[Ref]

Abnormal liver function test was reported in less than 2% of patients.[Ref]

Metabolic

Frequency not reported: Decreased appetite, gout[Ref]

Decreased appetite and gout were reported in less than 2% of patients.[Ref]

Musculoskeletal

Myalgia, muscle twitching, musculoskeletal stiffness, and arthritis were reported in less than 2% of patients.[Ref]

Common (1% to 10%): Back pain, arthralgia, muscle spasms
Frequency not reported: Myalgia, muscle twitching, musculoskeletal stiffness, arthritis[Ref]

Ocular

Increased lacrimation was reported in less than 2% of patients.[Ref]

Frequency not reported: Increased lacrimation[Ref]

Other

Common (1% to 10%): Drug withdrawal syndrome, fatigue, hot flush
Frequency not reported: Vertigo, tinnitus, chills, pain, influenza like illness, pyrexia, malaise, intentional surgical and medical procedure misuse[Ref]

Vertigo, tinnitus, chills, pain, influenza like illness, pyrexia, malaise, and intentional surgical/medical procedure misuse were reported in less than 2% of patients.[Ref]

References

1. "Product Information. Troxyca ER (naltrexone-oxyCODONE)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

It is possible that some side effects of naltrexone / oxycodone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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