Ibuprofen/Oxycodone Side Effects

Please note - some side effects for Ibuprofen/Oxycodone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ibuprofen/Oxycodone - for the Consumer

Ibuprofen/Oxycodone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ibuprofen/Oxycodone:

Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; infection; nausea; nervousness; sleeplessness; stomach pain; swelling; tiredness; upset stomach; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blurred vision or other eye problems; chest pain; dark urine; fainting; fast or irregular heartbeat; fever; increased or decreased urination; irregular or difficult breathing; mental or mood changes; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent stomach pain; stiff neck; swelling of the arms or legs; unusual tiredness or weakness; unusual weight gain; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Side Effects by Body System

Gastrointestinal

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.

Nervous system

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.

Hepatic

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

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

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

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.

Cardiovascular

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

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

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.

Dermatologic

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

Musculoskeletal side effects have rarely included arthritis.

Genitourinary

Genitourinary side effects have rarely included urinary frequency.

Other

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

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.

Other

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

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

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.

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