Nabumetone Side Effects

Some side effects of nabumetone 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 nabumetone: oral tablet

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

Stop taking nabumetone 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;

• swelling or rapid weight gain;

• 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 nabumetone may include:

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

• bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to nabumetone: oral tablet

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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