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Naltrexone / oxycodone Side Effects

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

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

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]

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

Common (1% to 10%): Dizziness, headache, hypoesthesia, somnolence, tremor

Postmarketing reports: Serotonin syndrome[Ref]

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

Frequency not reported: Anemia, lymphadenopathy[Ref]

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

Hepatic

Frequency not reported: Abnormal liver function test[Ref]

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

Metabolic

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

Frequency not reported: Decreased appetite, gout[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, muscle spasms

Frequency not reported: Myalgia, muscle twitching, musculoskeletal stiffness, arthritis[Ref]

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

Medically reviewed by Drugs.com. Last updated on Mar 2, 2021.

More about naltrexone / oxycodone

Consumer resources

Other brands
Troxyca ER

Professional resources

Related treatment guides

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.