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RoxyBond Side Effects

Generic name: oxycodone

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

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

Applies to oxycodone: oral conventional or extended-release preparations.

Warning

Special Alerts:

  • FDA drug safety communication (4/13/2023):500 As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).

  • Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.

  • Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.

  • A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.

  • Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).

  • Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.

REMS:

FDA approved a REMS for oxycodone to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of oxycodone and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).

Side effects include:

Constipation, nausea, sedation/somnolence, dizziness, lightheadedness, vomiting, pruritus, headache, insomnia, dry mouth, sweating, asthenia.

For Healthcare Professionals

Applies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release.

General

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.[Ref]

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 syndrome[Ref]

Respiratory

Frequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis[Ref]

Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone.[Ref]

Gastrointestinal

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[Ref]

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.[Ref]

Psychiatric

Frequency not reported: Paranoia, psychosis, hallucinations, agitation, anxiety[Ref]

Dermatologic

Common (1% to 10%): Pruritus, hyperhidrosis, rash

Frequency not reported: Herpes simplex, rash, sweating, urticaria[Ref]

Hepatic

Frequency not reported: Increased hepatic enzymes

Cardiovascular

Frequency not reported: QTc prolongation at higher doses, deep thrombophlebitis, heart failure, hemorrhage, hypotension, palpitation, tachycardia, edema, peripheral edema, vasodilation, circulatory collapse[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary retention

Frequency not reported: Urinary tract infection[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction

Postmarketing reports: Anaphylaxis[Ref]

Immunologic

Frequency not reported: Flu syndrome, infection, sepsis[Ref]

Metabolic

Common (1% to 10%): Decreased appetite (pediatrics)

Frequency not reported: Gout, hyperglycemia, iron deficiency anemia[Ref]

Musculoskeletal

Frequency not reported: Back pain, neck pain, arthralgia, arthritis, bone pain, myalgia, pathological fracture[Ref]

Ocular

Frequency not reported: Photosensitivity reaction, amblyopia[Ref]

Other

Very common (10% or more): Pyrexia (11%, pediatrics)

Frequency not reported: Chills and fever, accidental injury[Ref]

Endocrine

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]

Frequently asked questions

References

1. Leow KP, Smith MT, Watt JA, Williams BE, Cramond T. Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration. Ther Drug Monit. 1992;14:479-84.

2. Product Information. OxyContin (oxycodone). Purdue Frederick Company. 2001.

3. Leow KP, Smith MT, Williams B, Cramond T. Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer. Clin Pharmacol Ther. 1992;52:487-95.

4. Glare P, Walsh D. Dose-ranging study of oxycodone for advanced cancer pain (meeting abstract). Proc Annu Meet Am Soc Clin Oncol. 1991;10:a1201.

5. Glare PA, Walsh TD. Dose-ranging study of oxycodone for chronic pain in advanced cancer. J Clin Oncol. 1993;11:973-8.

6. Sunshine A, Olson NZ, Zighelboim I, Decastro A. Ketoprofen, acetaminophen plus oxycodone, and acetaminophen in the relief of postoperative pain. Clin Pharmacol Ther. 1993;54:546-55.

7. Cerner Multum, Inc. UK Summary of Product Characteristics.

8. Product Information. Xtampza ER (oxycodone). Patheon. 2016.

9. Fishbain DA, Goldberg M, Rosomoff RS, Rosomoff H. Atypical withdrawal syndrome (organic delusional syndrome) secondary to oxycodone detoxification . J Clin Psychopharmacol. 1988;8:441-2.

10. Fanoe S, Jensen GB, Sjogren P, Korsgaard MP, Grunnet M. Oxycodone is associated with dose-dependent QTc prolongation in patients and low-affinity inhibiting of hERG activity in vitro. Br J Clin Pharmacol. 2008;67:172-9.

11. Gardos G. Dyskinesia after discountinuation of compound analgesic containing oxycodone . Lancet. 1977;1:759-60.

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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