Note: This document contains side effect information about naltrexone / oxycodone. Some dosage forms listed on this page may not apply to the brand name Troxyca ER.

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]

Frequently asked questions

• How is Troxyca ER formulated to be abuse deterrent?