Ibuprofen / oxycodone Side Effects

Not all side effects for ibuprofen / oxycodone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ibuprofen / oxycodone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ibuprofen / oxycodone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ibuprofen / oxycodone:

Less common
  • Feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • headache
  • sweating
Rare
  • Abdominal or stomach pain
  • blurred vision
  • changes in skin color
  • chest pain
  • confusion
  • convulsions
  • decrease in frequency of urination
  • decreased urine
  • difficulty with breathing
  • difficulty in passing urine (dribbling)
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying position
  • dry mouth
  • excessive muscle tone
  • fainting
  • fast heartbeat
  • fast, pounding, or irregular heartbeat or pulse
  • increased need to urinate
  • increased thirst
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • muscle stiffness
  • muscle tension or tightness
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pain, tenderness, or swelling of the foot or leg
  • painful urination
  • pale skin
  • passing urine more often
  • severe constipation
  • severe vomiting
  • shortness of breath
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness

If any of the following symptoms of overdose occur while taking ibuprofen / oxycodone, get emergency help immediately:

Symptoms of overdose
  • Change in consciousness
  • chest pain or discomfort
  • cold and clammy skin
  • constricted pupils
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased awareness or responsiveness
  • difficult or troubled breathing
  • difficulty with sleeping
  • disorientation
  • drowsiness to profound coma
  • fainting
  • hallucination
  • hearing loss
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • loss of bladder control
  • loss of consciousness
  • muscle spasm or jerking of all extremities
  • pale or blue lips, fingernails, or skin
  • severe sleepiness
  • skeletal muscle flaccidity
  • sleepiness or unusual drowsiness
  • sudden fainting
  • sudden loss of consciousness

Some of the side effects that can occur with ibuprofen / oxycodone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • bloated full feeling
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in the stomach or intestines
  • fever
  • heartburn
  • indigestion
  • lack or loss of strength
  • passing gas
  • stomach discomfort, upset, or pain
Rare
  • Back pain
  • body aches or pain
  • bruising, large, flat, blue or purplish patches in the skin
  • changes in vision
  • chills
  • congestion
  • cough or hoarseness
  • delusions
  • dementia
  • difficult urination
  • difficulty with moving
  • dryness or soreness of the throat
  • enlarged abdomen or stomach
  • false or unusual sense of well-being
  • fear
  • hoarseness
  • impaired vision
  • increase in body movements
  • lower back or side pain
  • nervousness
  • pain, swelling, or redness in the joints
  • rash
  • runny nose
  • sleeplessness
  • swelling
  • taste perversion
  • tender, swollen glands in the neck
  • trouble with sleeping
  • trouble with swallowing
  • unable to sleep
  • voice changes

For Healthcare Professionals

Applies to ibuprofen / oxycodone: oral tablet

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.[Ref]

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.[Ref]

Nervous system

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.[Ref]

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.[Ref]

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).[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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%).[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Dermatologic

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.[Ref]

Diphenhydramine (25 to 50 mg) has been shown to be helpful for opioid-associated pruritus.[Ref]

Musculoskeletal

Musculoskeletal side effects have rarely included arthritis.[Ref]

Genitourinary

Genitourinary side effects have rarely included urinary frequency.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Other side effects associated with ibuprofen therapy have included fluid retention and edema, tinnitus (1% to 3%), and vertigo.[Ref]

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.[Ref]

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.[Ref]

References

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