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Note: This document contains side effect information about oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Roxicodone.For the Consumer
Applies to oxycodone: oral capsule, oral capsule extended release, oral solution, oral tablet, oral tablet extended release
Oral route (Capsule, Extended Release)
Addiction, Abuse, and MisuseOxycodone extended-release (ER) exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing oxycodone ER, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxycodone ER. Monitor for respiratory depression, especially during initiation of oxycodone ER or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of oxycodone ER, especially by children, can result in a fatal overdose of oxycodone ER.Neonatal Opioid Withdrawal SyndromeProlonged use of oxycodone ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of oxycodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone ER and any CYP3A4 inhibitor or inducer.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of oxycodone ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Oral route (Tablet; Tablet, Extended Release)
Addiction, abuse, and misuse, leading to overdose and death has been reported. Before prescribing, assess the patient's risk and watch for signs of the development of these behaviors. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Serious and fatal respiratory depression may occur. Monitor for respiratory depression, especially when beginning treatment or increasing dose. Advise patients to swallow tablets whole to avoid overdose. Accidental ingestion can result in a fatal overdose, especially in children. Prolonged use in pregnancy may lead to life-threatening neonatal withdrawal syndrome. If oxycodone hydrochloride must be used during pregnancy, advise the patient of the risk and ensure that treatment will be available to the infant. Initiation of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can cause a fatal oxycodone hydrochloride overdose. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
Oral route (Solution)
Use caution when prescribing and administering oxycodone oral solution as dosing errors due to mg and mL could result in accidental overdose and death. Ensure the proper dose is indicated and dispensed. Oxycodone oral solution should be kept out of the reach of children. Seek emergency help immediately if accidental ingestion occurs.
Along with its needed effects, oxycodone (the active ingredient contained in Roxicodone) 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 oxycodone:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking oxycodone:
Symptoms of overdose
Some side effects of 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:
For Healthcare Professionals
Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended releaseGeneral
The most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation.Nervous system
Very common (10% or more): Headache (14%, pediatrics)
Common (1% to 10%): Dizziness (pediatrics)
Frequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine
Postmarketing reports: Serotonin syndromeRespiratory
Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.
Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitisGastrointestinal
Very common (10% or more): Nausea (23% to 27%), constipation (23% to 26%), vomiting (12% to 14%)
Frequency not reported: Abdominal pain, anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis
In pediatric studies with the oral extended release product, gastrointestinal adverse events were reported in 40% of patients 11 to 16 years of age (56 of 140); vomiting, nausea, constipation, and diarrhea were experienced by 21%, 15%, 9%, and 6%, respectively. Abdominal pain and gastroesophageal reflux disease were reported in 1% to less than 5% of patients.Psychiatric
Frequency not reported: Paranoia, psychosis, hallucinations, agitation, anxietyDermatologic
Common (1% to 10%): Pruritus, hyperhidrosis, rash
Frequency not reported: Herpes simplex, rash, sweating, urticariaHepatic
Frequency not reported: Increased hepatic enzymesCardiovascular
Frequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapseGenitourinary
Common (1% to 10%): Dysuria, urinary retention
Frequency not reported: Urinary tract infectionHypersensitivity
Frequency not reported: Allergic reaction
Postmarketing reports: AnaphylaxisImmunologic
Frequency not reported: Flu syndrome, infection, sepsisMetabolic
Common (1% to 10%): Decreased appetite (pediatrics)
Frequency not reported: Gout, hyperglycemia, iron deficiency anemiaMusculoskeletal
Frequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fractureOcular
Frequency not reported: Photosensitivity reaction, amblyopiaOther
Very common (10% or more): Pyrexia (11%, pediatrics)
Frequency not reported: Chills and fever, accidental injuryEndocrine
Postmarketing reports: Adrenal insufficiency, androgen deficiency