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Roxicodone Side Effects

Generic name: oxycodone

Medically reviewed by Drugs.com. Last updated on Mar 29, 2021.

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 conventional or extended-release preparations

Warning

    Addiction, Abuse, and Misuse
  • Risk of addiction, abuse, and misuse, which can lead to overdosage and death.290 291 303 305 Assess each patient’s risk for addiction, abuse, and misuse before prescribing the drug; monitor all patients regularly for development of these behaviors or conditions.290 291 303 305 (See Addiction, Abuse, and Misuse under Cautions.)

    Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur.290 291 303 305 Monitor for respiratory depression, especially during initiation of therapy and following dosage increases.290 291 303 305 (See Respiratory Depression under Cautions.)

  • Patients must swallow extended-release tablets whole to avoid exposure to a potentially fatal dose.290 305

    Accidental Exposure
  • Accidental ingestion of even 1 dose, especially by a child, can result in a fatal overdose.290 291 303 305

    Neonatal Opiate Withdrawal
  • Prolonged maternal use of opiates during pregnancy can result in neonatal withdrawal syndrome, which may be life-threatening if not recognized and treated.290 291 303 305 Advise women who require such therapy during pregnancy of this risk and ensure appropriate treatment will be available.290 291 303 305 (See Pregnancy under Cautions.)

    CYP3A4-mediated Interactions
  • Initiation of CYP3A4 inhibitors or discontinuance of CYP3A4 inducers can result in fatal oxycodone overdosage.290 291 303

    Medication Errors with Oral Solutions
  • Potential for medication errors resulting in inadvertent overdosage and death due to confusion between mg and mL or between oxycodone hydrochloride solution (5 mg/5 mL) and oxycodone hydrochloride oral concentrate solution (100 mg/5 mL).299 304 Take care to ensure that the correct dose is communicated and dispensed.299 304

  • Use oral concentrate solution only in opiate-tolerant patients.304

  • Keep oral solutions out of the reach of children.299 304 If accidental ingestion occurs, seek immediate medical attention.299 304

    Concomitant Use with Benzodiazepines or Other CNS Depressants
  • Concomitant use of opiate agonists with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.416 417 418 700 701 702 703

  • Reserve concomitant use of opiate analgesics and benzodiazepines or other CNS depressants for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.700 703 (See Specific Drugs under Interactions.)

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 14 (1992): 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 52 (1992): 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 10 (1991): a1201

5. Glare PA, Walsh TD "Dose-ranging study of oxycodone for chronic pain in advanced cancer." J Clin Oncol 11 (1993): 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 54 (1993): 546-55

7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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 8 (1988): 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 67 (2008): 172-9

11. Gardos G "Dyskinesia after discountinuation of compound analgesic containing oxycodone ." Lancet 1 (1977): 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.