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Combunox Side Effects

Generic name: ibuprofen / oxycodone

Medically reviewed by Drugs.com. Last updated on Apr 9, 2023.

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

Applies to ibuprofen / oxycodone: oral tablet.

Warning

Oral route (Tablet)

Oxycodone hydrochloride/ibuprofen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of oxycodone hydrochloride/ibuprofen, especially in children, can result in fatal overdose of oxycodone hydrochloride and ibuprofen. Prolonged use of oxycodone hydrochloride/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. 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. Concomitant use of cytochrome P450 3A4 inhibitors or discontinuation of concomitantly used cytochrome P450 3A4 inducers may affect the plasma levels of oxycodone and lead to increased adverse reactions and fatal respiratory depression. Monitor patients carefully when oxycodone hydrochloride/ibuprofen and cytochrome P450 3A4 inhibitors and inducers are concurrently used. 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. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxycodone hydrochloride/ibuprofen is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also increase the risk of serious gastrointestinal (GI) adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines) especially in the elderly and patients with a prior history of ulcer disease and/or GI bleeding, which can be fatal.

Serious side effects of Combunox

Along with its needed effects, ibuprofen / oxycodone 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 ibuprofen / oxycodone:

Less common

Rare

Get emergency help immediately if any of the following symptoms of overdose occur while taking ibuprofen / oxycodone:

Symptoms of overdose

Other side effects of Combunox

Some side effects of ibuprofen / 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:

Less common

Rare

For Healthcare Professionals

Applies to ibuprofen / oxycodone: oral tablet.

General

The most commonly reported adverse events have included nausea, vomiting, flatulence, somnolence, and dizziness.[Ref]

Gastrointestinal

Abdominal pain, enlarged abdomen, dry mouth, dyspepsia, eructation, and ileus, have been reported in less than 1% of patients.[Ref]

Common (1% to 10%): Nausea, vomiting, flatulence, constipation, diarrhea, dyspepsia

Frequency not reported: Abdominal pain, enlarged abdomen, dry mouth, eructation, ileus

Postmarketing reports:[Ref]

Cardiovascular

Hypotension, syncope, tachycardia, edema, and chest pain have been reported in less than 1% of patients.[Ref]

Common (1% to 10%): Vasodilation, thrombophlebitis

Frequency not reported: Hypotension, syncope, tachycardia, vasodilation, edema, chest pain[Ref]

Nervous system

Very common (10% or more): Dizziness (19.2%), somnolence (17.4%), headache (10.2%)

Common (1% to 10%): Hyperkinesia, hypertonia

Frequency not reported: Taste perversion

Postmarketing reports: Serotonin syndrome[Ref]

Respiratory

Frequency not reported: Respiratory depression[Ref]

Dermatologic

Common (1% to 10%): Sweat, rash[Ref]

Metabolic

Frequency not reported: Hypokalemia[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis[Ref]

Hematologic

Common (1% to 10%): Ecchymosis

Frequency not reported: Anemia[Ref]

Psychiatric

Frequency not reported: Insomnia, euphoria, nervousness, abnormal thinking, anxiety[Ref]

Insomnia, euphoria, nervousness, abnormal thinking, and anxiety have been reported in less than 1% of patients.[Ref]

Endocrine

Postmarketing reports: Adrenal insufficiency, androgen deficiency

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Musculoskeletal

Frequency not reported: Arthritis, back pain[Ref]

Genitourinary

Frequency not reported: Urinary frequency[Ref]

Other

Common (1% to 10%): Fever, asthenia

Frequency not reported: Chills[Ref]

Ocular

Frequency not reported: Amblyopia[Ref]

References

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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.