Oxaprozin Side Effects

Some side effects of oxaprozin 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 oxaprozin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking oxaprozin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking oxaprozin and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 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;

• urinating less than usual or not at all;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of oxaprozin may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• dry mouth;

• increased sweating, runny nose;

• blurred vision; or

• ringing in your ears.

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 oxaprozin: oral tablet

Gastrointestinal

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Oxaprozin should be used with caution in these patients.

Gastrointestinal side effects associated with oxaprozin include nausea (8%), dyspepsia (8%), diarrhea (3% to 9%), constipation (3% to 9%), anorexia, vomiting, and flatulence. More serious gastrointestinal effects such as peptic ulceration, gastrointestinal bleeding, and rectal bleeding have been reported.

Hepatic

Hepatic side effects include elevations in serum transaminases in up to 12% of patients. Hepatitis has been reported in less than 1% of patients. A case of fatal, fulminant hepatitis has been reported with oxaprozin use.

Elevations in liver function tests three times normal values occurred in 1.4% of patients treated with oxaprozin.

While oxaprozin-induced elevations in liver function tests are usually mild and transient, fatal hepatitis has been reported with oxaprozin. Patients who develop persistent or significant elevations in liver function tests and/or signs or symptoms suggestive of hepatic dysfunction should be evaluated for more severe hepatotoxicity.

Renal

Renal side effects include interstitial nephritis, membranous nephropathy, hematuria, nephrotic syndrome, oliguria/polyuria, proteinuria, and acute renal failure.

Oxaprozin 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 oxaprozin-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control 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.

Cardiovascular

Cardiovascular side effects have included fluid retention and edema which may be important in patients with heart failure. In addition, blood pressure may be elevated by oxaprozin which may have clinical relevance in patients with comorbid illnesses.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Nervous system

Nervous system side effects have included depression (i.e. sedation, somnolence, confusion, and depression), sleep disturbances, weakness, fatigue, headache, and vertigo have been reported.

Dermatologic

Dermatologic side effects have included rash (3% to 9%), alopecia, pruritus, exfoliative dermatitis, pseudoporphyria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell's syndrome). Photosensitivity characterized by vesicular eruptions has been reported. Pseudoporphyria, or bullous photosensitivity, has also been reported. Angioedema and sweat have been reported in patients taking other NSAIDs.

Hematologic

Hematologic side effects have included agranulocytosis, pancytopenia, anemia, thrombocytopenia, leukopenia, and ecchymoses. Prolonged bleeding time may occur as well.

Hypersensitivity

Hypersensitivity reactions occur in less than 1% of patients and may manifest as urticaria and anaphylaxis.

Other

Other side effects of oxaprozin include tinnitus, blurred vision, and conjunctivitis. In addition, oxaprozin may cause a false positive result on urine drug screening for benzodiazepines.

Psychiatric

Psychiatric disturbances, including confusion, delusions, depression, hallucinations, paranoid reactions, and panic disorders, although rare, have been noted with oxaprozin use.

Genitourinary

Genitourinary side effects have included an increase or decrease in menstrual flow in less than 1% of patients.

Respiratory

Respiratory side effects (<1%) have included asthma, dyspnea, respiratory depression, sinusitis, symptoms of upper respiratory tract infection, pulmonary infections, and pneumonia.

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