Nabumetone Side Effects

Brand Names: Relafen

Please note - some side effects for Nabumetone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nabumetone - for the Consumer

Nabumetone

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 Nabumetone:

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

Seek medical attention right away if any of these SEVERE side effects occur when using Nabumetone:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nabumetone Side Effects - for the Professional

Nabumetone

Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of U.S. clinical studies.

Of the 1,677 patients who received Nabumetone during U.S. clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year and 750 for at least 2 years. Over 300 patients have been treated for 5 years or longer.

The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia and abdominal pain.

Incidence ≥ 1% - Probably Causally Related

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness*, headache*, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus*, rash*.

Special Senses: Tinnitus*.

Miscellaneous: Edema*.

*Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3%

of the patients are unmarked.

Incidence < 1% - Probably Causally Related†

Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.

Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.

Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson Syndrome.

Cardiovascular: Vasculitis.

Metabolic: Weight gain.

Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.

Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

Special Senses: Abnormal vision.

Hematologic/Lymphatic: Thrombocytopenia.

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic edema.

† Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.

Incidence < 1% - Causal Relationship Unknown

Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.

Central Nervous System: Nightmares.

Dermatologic: Acne, alopecia.

Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.

Respiratory: Asthma, cough.

Genitourinary: Dysuria, hematuria, impotence, renal stones.

Special Senses: Taste disorder.

Body as a Whole: Fever, chills.

Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.

Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

In a study designed to measure gastrointestinal blood loss associated with the oral administration of nabumetone, aspirin, or placebo in healthy volunteers, nabumetone was not statistically different from placebo while aspirin was associated with significant gastrointestinal microbleeding. In addition, endoscopy studies have confirmed a reduced incidence of gastropathy associated with nabumetone compared to other nonsteroidal anti-inflammatory agents.

In a follow-up study involving 1,677 patients treated with nabumetone for up to 8 years, serious gastrointestinal side effects such as ulceration, bleeding, and/or perforation, occurred in 16 patients, representing a cumulative incidence of 0.95%.

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

Gastrointestinal side effects have been reported the most frequently. These have included diarrhea (14%), dyspepsia (13%), and abdominal pain (12%). Between 3% to 9% of patients have reported nausea, constipation, positive stool guaiac, and flatulence. Adverse effects occurring in less than 3% of the patients have included dry mouth, gastritis, stomatitis, vomiting, anorexia, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, and increased appetite. Despite the fact that nabumetone is a nonacidic prodrug, and as such, has a decreased propensity for causing gastric mucosal damage, serious gastrointestinal side effects, such as bleeding, ulceration, and perforation have been reported in up to 0.95% of patients.

Hepatic

Elevations in serum transaminases three times normal values are reported in less than 1% of patients treated with nabumetone. Serious hepatotoxicity, including fatal fulminant hepatitis, is reported with other nonsteroidal anti-inflammatory agents. Patients with signs or symptoms of hepatic dysfunction or who develop significant elevations in serum transaminases during nabumetone therapy should be evaluated for evidence of more serious hepatotoxicity.

Hepatic side effects have included borderline elevations in liver function tests in up to 15% of patients as well as rare cases of cholestatic jaundice. Due to this patient's liver disease, cautious use of nabumetone and frequent monitoring of liver function tests during therapy is recommended.

Renal

Renal side effects have included albuminuria, azotemia, nephrotic syndrome, and interstitial nephritis, as well as rare reports of renal failure, dysuria, hematuria, and renal stones. A fatal case of acute renal failure has also been reported. Due to this patient's liver disease, cautious use of nabumetone and frequent monitoring of liver function tests during therapy is recommended.

Nabumetone 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 nabumetone-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.

Dermatologic

Dermatologic side effects have included rash (6.9%) and pruritus (3.9%). Acne, alopecia, bullous eruptions, photosensitivity, pseudoporphyria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Pseudoporphyria was diagnosed in two patients after approximately 16 months of nabumetone therapy. Skin fragility persisted for longer than 12 months. High factor sunscreens were used on these patients.

Hematologic

Hematologic side effects have rarely included iron deficiency anemia, aplastic anemia, thrombocytopenia, granulocytopenia, and leukopenia.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions, anaphylaxis, facial itching, angioedema, urticaria, and bronchospasm.

Nervous system

Nervous system side effects have included headache (9.2%) and dizziness (5.7%). Asthenia, fatigue, insomnia, nervousness, somnolence, tremor, agitation, anxiety, confusion, depression, malaise, vertigo, and nightmares have also been reported.

Psychiatric

Psychiatric side effects have included rare reports of agitation, anxiety, and depression.

Cardiovascular

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 mediations in patients already being treated with antihypertensive drugs.

Cardiovascular side effects have included vasculitis. Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, and thrombophlebitis have also been reported.

Respiratory

Pulmonary fibrosis was reported in a 68-year-old female with osteoarthritis and osteoporosis treated with nabumetone 1500 mg per day. Symptoms of shortness of breath and dry cough began within 2 weeks of initiation of therapy, and progressed over a course of 6 weeks until the diagnosis of drug-induced pulmonary fibrosis was made. Treatment, consisting of corticosteroids and discontinuation of nabumetone, resulted in rapid resolution of physical signs and symptoms.

Respiratory side effects have rarely included dyspnea, asthma, cough, idiopathic interstitial pneumonitis, eosinophilic pneumonia, and hypersensitivity pneumonitis. A case of pulmonary fibrosis has also been reported.

Other

Other side effects have included tinnitus (3.9%), abnormal vision, taste disorder, fever, and chills.

Genitourinary

Genitourinary side effects have included albuminuria, azotemia, hematuria, dysuria, hyperuricemia, impotence interstitial nephritis, nephrotic syndrome, renal stones, and vaginal bleeding.

Metabolic

Metabolic side effects have included weight loss, hyperglycemia, and hypokalemia.

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