Oxaprozin Side Effects

Brand Names: Daypro

Please note - some side effects for Oxaprozin 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 Oxaprozin - for the Consumer

Oxaprozin

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 Oxaprozin:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Oxaprozin Side Effects - for the Professional

Oxaprozin

Adverse reaction data were derived from patients who received Oxaprozin in multidose, controlled, and open-label clinical trials, and from worldwide marketing experience. Rates for events occurring in more than 1% of patients, and for most of the less common events, are based on 2253 patients who took 1200 to 1800 mg Oxaprozin per day in clinical trials. Of these, 1721 were treated for at least 1 month, 971 for at least 3 months, and 366 for more than 1 year. Rates for the rarer events and for events reported from worldwide marketing experience are difficult to estimate accurately and are only listed as less than 1%.

INCIDENCE GREATER THAN 1%

In clinical trials of Oxaprozin or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%.

Cardiovascular system: edema.

Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.

Hematologic system: anemia, increased bleeding time.

Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.

Skin and appendages: pruritus, rash.

Special senses: tinnitus.

Urogenital system: abnormal renal function, dysuria or frequency.

INCIDENCE LESS THAN 1%

The following adverse reactions were reported in clinical trials, from worldwide marketing experience (in italics) or in patients taking other NSAIDs.

Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis, serum sickness.

Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.

Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including hepatitis, liver failure, stomatitis, hemorrhoidal or rectal bleeding, pancreatitis.

Hematologic system: agranulocytosis, aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, pancytopenia, purpura, thrombocytopenia, leukopenia.

Metabolic system: hyperglycemia, weight changes.

Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.

Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.

Skin: alopecia, angioedema, urticaria, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, StevensJohnson syndrome, sweat, toxic epidermal necrolysis (Lyell's syndrome).

Special senses: blurred vision, conjunctivitis, hearing decrease.

Urogenital: acute interstitial nephritis, cystitis, hematuria, increase in menstrual flow, nephrotic syndrome, oliguria/polyuria, proteinuria, renal insufficiency, acute renal failure, decreased menstrual flow.

Oxaprozin Tablets

Adverse reaction data were derived from patients who received Oxaprozin in multidose, controlled, and open-label clinical trials, and from worldwide marketing experience. Rates for events occurring in more than 1% of patients, and for most of the less common events, are based on 2253 patients who took 1200 to 1800 mg Oxaprozin per day in clinical trials. Of these, 1721 were treated for at least 1 month, 971 for at least 3 months, and 366 for more than 1 year. Rates for the rarer events and for events reported from worldwide marketing experience are difficult to estimate accurately and are only listed as less than 1%.

INCIDENCE GREATER THAN 1%: In clinical trials of Oxaprozin or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%.

Cardiovascular system: edema.

Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.

Hematologic system: anemia, increased bleeding time.

Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.

Skin and appendages: pruritus, rash.

Special senses: tinnitus.

Urogenital system: abnormal renal function, dysuria or frequency.

INCIDENCE LESS THAN 1%: The following adverse reactions were reported in clinical trials, from worldwide marketing experience (in italics) or in patients taking other NSAIDs.

Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis, serum sickness.

Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.

Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including hepatitis, liver failure, stomatitis, hemorrhoidal or rectal bleeding, pancreatitis.

Hematologic system: agranulocytosis, aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, pancytopenia, purpura, thrombocytopenia, leukopenia.

Metabolic system: hyperglycemia, weight changes.

Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.

Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.

Skin: alopecia, angioedema, urticaria, photosensitivity, pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, sweat, toxic epidermal necrolysis (Lyell's syndrome).

Special senses: blurred vision, conjunctivitis, hearing decrease.

Urogenital: acute interstitial nephritis, cystitis, hematuria, increase in menstrual flow, nephrotic syndrome, oliguria/polyuria, proteinuria, renal insufficiency, acute renal failure, decreased menstrual flow.

Side Effects by Body System

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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