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Naltrexone / oxycodone Side Effects

For the Consumer

Applies to naltrexone / oxycodone: oral capsule extended release

Along with its needed effects, naltrexone/oxycodone 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 naltrexone / oxycodone:

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

Some side effects of naltrexone / oxycodone 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

  • 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.

Further information

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.

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