Combunox Side Effects
Generic name: ibuprofen / oxycodone
Note: This document contains side effect information about ibuprofen / oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Combunox.
Some side effects of Combunox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to ibuprofen / oxycodone: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking ibuprofen / oxycodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using ibuprofen and oxycodone and call your doctor at once if you have a serious side effect such as:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain;
shallow breathing, slow heartbeat;
confusion, feeling light-headed, fainting;
easy bruising or bleeding;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe blistering, peeling, and red skin rash; or
fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects include:
headache, dizziness, drowsiness;
mild nausea, vomiting, upset stomach, bloating, gas, constipation, diarrhea;
blurred vision; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
For Healthcare Professionals
Applies to ibuprofen / oxycodone: oral tablet
Gastrointestinal side effects have included nausea (8.8% to 25.4%), vomiting (4.5% to 5.3%), constipation (4.5%), dyspepsia (2.1%), diarrhea (2.1%), flatulence (1%). Dry mouth, eructation, ileus, and taste perversion have occurred rarely. More serious side effects associated with ibuprofen are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, pancreatitis, small bowel enteropathies, colonic and pyloric channel strictures, and ibuprofen-associated colitis. Bloody vomiting has been associated with ibuprofen overdose.
The incidence of gastrointestinal blood loss associated with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.
Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Ibuprofen should be used with caution in these patients.
Ibuprofen therapy in patients with systemic lupus erythematosus and related connective tissue disorders has been associated with rare reports of aseptic meningitis. However, there have been reports in patients without any underlying chronic condition.
Nervous system side effects have included somnolence (7.3% to 17.4%) and dizziness (5.1% to 19.2%). Abnormal thinking, anxiety, hyperkinesia, and hypertonia have been reported rarely.
Nervous system side effects associated with oxycodone have included drowsiness (23% to 24%), sedation, headache (7%), dry mouth (7%), and lightheadedness.
Aseptic meningitis associated with ibuprofen has been described in several case reports. Also, paresthesias and pseudotumor cerebri have been associated with ibuprofen, although causality is unknown.
Elevations in liver function tests, SGPT (ALT) or SGOT (AST), three times normal values occur in less than 1% of patients in controlled clinical trials with NSAIDs.
Cases of jaundice and fatal hepatitis have been associated with ibuprofen and other NSAIDs.
A patient on ibuprofen-oxycodone therapy with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has been reported, should be evaluated for evidence of the development of more severe hepatic dysfunction. Discontinuation of ibuprofen-oxycodone therapy should occur if abnormal liver tests persist or worsen, if clinical signs consistent with liver disease develop, or if systemic manifestations occur (for example, eosinophilia, rash, etc).
Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Rarely, jaundice, cholestasis, hepatitis, and hepatic failure have been reported. Ibuprofen has also been implicated in the so-called acute vanishing bile duct syndrome in children and in cases of acute hepatitis in patients with established stable, chronic hepatitis C infection.
Respiratory side effects have included respiratory depression.
Respiratory side effects associated with oxycodone have included respiratory depression, apnea, respiratory arrest, and rarely circulatory collapse.
Respiratory side effects associated with ibuprofen have included noncardiogenic pulmonary edema.
Opioids, like oxycodone, may cause dose-related respiratory depression through direct action on the brain stem respiratory centers. The elderly or debilitated patients may be more susceptible to respiratory depression especially when administered in large doses or in conjunction with other agents that depress respiration.
Renal side effects associated with ibuprofen have included mild renal insufficiency, nephrotic syndrome with and without renal failure, acute renal failure due to tubulointerstitial nephritis, papillary necrosis and acute tubular necrosis.
ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.
A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
Metabolic side effects have rarely included hypokalemia.
Metabolic side effects associated with ibuprofen have included hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH). In addition, gynecomastia, hypoglycemia, and acidosis have been associated with ibuprofen therapy, although causality is unknown. Hyperkalemia has been associated with ibuprofen overdose.
A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.
Cardiovascular side effects have included vasodilation (3%). Hypotension, syncope, tachycardia, and thrombophlebitis have occurred rarely.
Cardiovascular side effects associated with ibuprofen have included peripheral edema (1% to 3%), and elevated blood pressure (<1%).
Hypersensitivity side effects associated with ibuprofen have included erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions. Cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates have been reported rarely with ibuprofen.
Hematologic side effects associated with ibuprofen have included anemia, platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit.
Anemia associated with NSAIDs, including ibuprofen, may be the result of fluid retention, GI loss, or an incompletely described effect on erythropoiesis.
Reductions in serum hemoglobin concentrations are uncommon, and are usually associated with occult gastrointestinal blood loss. Ibuprofen induces an antiplatelet effect for at least 6 hours while preserving normal antiplatelet mechanisms.
Diphenhydramine (25 to 50 mg) has been shown to be helpful for opioid-associated pruritus.
Dermatologic side effects have rarely included ecchymosis and rash. Pruritus has been reported rarely with oxycodone.
Dermatologic side effects associated with ibuprofen have rarely included maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, vasculitis, Stevens-Johnson syndrome, and alopecia. Toxic epidermal necrolysis as well as photosensitivity reactions have been associated with ibuprofen, although causality is unknown.
Musculoskeletal side effects have rarely included arthritis.
Genitourinary side effects have rarely included urinary frequency.
Other side effects have included asthenia (3.3%), sweat (1.6%), abdominal pain, chest pain, and enlarged abdomen. Back pain, chills, infection have occurred rarely.
Other side effects associated with oxycodone have included withdrawal symptoms. These effects can occur after either abrupt cessation or fast tapering of narcotic analgesics, and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, piloerection, and sweating. Psychosis has been associated with oxycodone withdrawal.
Ibuprofen-oxycodone should be used with caution in patients with a history of cardiac decompensation, hypertension, or heart failure due to the potential for edema and fluid retention.
Other side effects associated with ibuprofen therapy have included fluid retention and edema, tinnitus (1% to 3%), and vertigo.
Psychiatric side effects associated with ibuprofen have included pseudodementia and psychotic exacerbation.
Psychiatric side effects associated with oxycodone have included paranoia, psychosis, and hallucinations. Psychosis has been reported with oxycodone withdrawal.
Ocular side effects have rarely included amblyopia.
Ocular side effects associated with ibuprofen have included blurred vision (<1%), scotomata, and diplopia. In addition, at least one case of corneal verticillata has been associated with ibuprofen.
More Combunox resources
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