Nabumetone

Unless your doctor tells you otherwise, continue your normal diet.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• lack of energy
• drowsiness
• nausea
• vomiting
• stomach pain
• difficulty breathing
• seizures
• coma (loss of consciousness for a period of time)

• Relafen^®

Yes

Medication Guide for
Non-Steroidal Anti-inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

• with longer use of NSAID medicines
• in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)".

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding:

• can happen without warning symptoms
• may cause death

The chance of a person getting an ulcer or bleeding increases with:

• taking medicines called "corticosteroids" and "anticoagulants"
• longer use
• smoking
• drinking alcohol
• older age
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• at the lowest dose possible for your treatment
• for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
• for pain right before or after heart bypass surgery

Tell your healthcare provider:

• about all of your medical conditions
• about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
• if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
• if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Get emergency help right away if you have any of the following symptoms:

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Serious side effects have been reported with nabumetone. See “Drug Precautions” section.

Common side effects of nabumetone include:

• diarrhea
• constipation
• gas or bloating
• dizziness
• headache
• dry mouth
• sores in the mouth
• nervousness
• difficulty falling asleep or staying asleep
• increased sweating
• ringing in the ears

This is not a complete list of nabumetone side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Take nabumetone exactly as prescribed.
• This medication comes in tablet form and is taken once or twice daily, with or without food.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of nabumetone at the same time.

Consider potential benefits and risks of nabumetone therapy as well as alternative therapies before initiating therapy with the drug.1 Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.1

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.1

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Headache
• itching skin
• nausea
• rash
• stomach pain
• swelling

• Burning feeling in chest or stomach
• indigestion
• stomach upset
• swelling or inflammation of the mouth
• tenderness in stomach area
• vomiting

• Bleeding gums
• blistering, peeling, loosening of skin
• bloody or black, tarry stools
• bloody or cloudy urine
• burning upper abdominal pain
• changes in vision
• chest pain
• chills
• clay-colored stools
• constipation
• cough
• dark-colored urine
• diarrhea
• difficult or labored breathing
• difficulty swallowing
• dizziness
• dry cough
• dry mouth
• fast heartbeat
• fever
• fluid-filled skin blisters
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• high blood pressure
• hives or welts
• increased sensitivity of skin to sunlight
• increased thirst
• joint pain, stiffness, or swelling
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• light-colored stools
• loss of appetite
• muscle pain
• pain in lower back or side
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid breathing
• red irritated eyes
• red skin lesions, often with a purple center
• redness or other discoloration of skin
• severe or continuing stomach pain
• severe sunburn
• shortness of breath
• skin thinness
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stomach bloating, burning, or cramping
• swelling of face, fingers, feet or lower legs
• tightness in chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vaginal bleeding
• vomiting of blood or material that looks like coffee grounds
• weight gain or loss
• wheezing
• yellow eyes or skin

• Agitation
• blurred vision
• coma
• confusion
• depression
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• muscle twitching
• nervousness
• pain or discomfort in chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• pounding in the ears
• seizures
• severe stomach pain
• slow heartbeat
• stupor
• unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated full feeling
• continuing ringing or buzzing or other unexplained noise in ears
• excess air or gas in stomach or intestines
• hearing loss
• indigestion
• mild diarrhea
• passing gas

• Increased sweating
• sleepiness or unusual drowsiness
• sleeplessness
• trouble sleeping
• unable to sleep

• Anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• increased appetite
• lack or loss of strength
• lightheadedness
• sensation of spinning
• shakiness in legs, arms, hands, feet
• trembling or shaking of hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain or heartburn.
• Upset stomach.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Gas.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Osteoarthritis: The use of Nabumetone in relieving the signs and symptoms of osteoarthritis (OA) was assessed in double-blind, controlled trials in which 1,047 patients were treated for 6 weeks to 6 months. In these trials, Nabumetone in a dose of 1,000 mg/day administered at night was comparable to naproxen 500 mg/day and to aspirin 3,600 mg/day.

Rheumatoid Arthritis: The use of Nabumetone in relieving the signs and symptoms of rheumatoid arthritis (RA) was assessed in double-blind, randomized, controlled trials in which 770 patients were treated for 3 weeks to 6 months. Nabumetone, in a dose of 1,000 mg/day administered at night, was comparable to naproxen 500 mg/day and to aspirin 3,600 mg/day.

In controlled clinical trials of rheumatoid arthritis patients, Nabumetone has been used in combination with gold, d-penicillamine, and corticosteroids.

Patient Exposure in Clinical Trials of Osteoarthritis and Rheumatoid Arthritis:

In clinical trials with osteoarthritis and rheumatoid arthritis patients, most patients responded to Nabumetone in doses of 1,000 mg/day administered nightly; total daily dosages up to 2,000 mg were used. In open-labeled studies, 1,490 patients were permitted dosage increases and were followed for approximately 1 year (mode). Twenty percent of patients (n = 294) were withdrawn for lack of effectiveness during the first year of these open-labeled studies. The following table provides patient exposure to doses used in the US clinical trials:

As with other NSAIDs, the lowest dose should be sought for each patient. Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients' requirements.

General:Nabumetone tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of Nabumetone tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hepatic Effects:Borderline elevations of 1 or more liver function tests may occur in up to 15% of patients taking NSAIDs including Nabumetone tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately 3 or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Nabumetone tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Nabumetone tablets should be discontinued.

Hematological Effects:Anemia is sometimes seen in patients receiving NSAIDs, including Nabumetone tablets. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Nabumetone tablets, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Nabumetone tablets who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored (see CLINICAL PHARMACOLOGY, Special Studies, Other).

Preexisting Asthma:Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other non-steroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Nabumetone tablets should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Photosensitivity :Based on ultraviolet (U.V.) light photosensitivity testing, Nabumetone may be associated with more reactions to sun exposure than might be expected based on skin tanning types.

Information for Patients:Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

1. Nabumetone tablets, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS,CARDIOVASCULAR EFFECTS).
2. Nabumetone tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects,Risk of Ulceration, Bleeding, and Perforation).
3. Nabumetone tablets, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
6. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).
7. In late pregnancy, as with other NSAIDs, Nabumetone tablets should be avoided because they may cause premature closure of the ductus arteriosus.

Laboratory Tests :Because serious G.I.tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs and symptoms of GI bleeding. Patients on long-term treatment with NSAIDs, should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, Nabumetone tablets should be discontinued.

Drug Interactions:

ACE-inhibitors:Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin:When Nabumetone tablets are administered with aspirin, its protein binding is reduced, although the clearance of free Nabumetone is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Nabumetone tablets and aspirin is not generally recommended because of the potential of increased adverse effects.

Diuretics: Clinical studies, as well as post marketing observations, have shown that Nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.

Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

In vitro studies have shown that, because of its affinity for protein, 6MNA may displace other protein-bound drugs from their binding site. Caution should be exercised when administering Nabumetone with warfarin since interactions have been seen with other NSAIDs.

Concomitant administration of an aluminum-containing antacid had no significant effect on the bioavailability of 6MNA. When administered with food or milk, there is more rapid absorption; however, the total amount of 6MNA in the plasma is unchanged (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Carcinogenesis, Mutagenesis: In 2 year studies conducted in mice and rats, Nabumetone had no statistically significant tumorigenic effect. Nabumetone did not show mutagenic potential in the Ames test and mouse micronucleus test in vivo; however, Nabumetone- and 6MNA-treated lymphocytes in culture showed chromosomal aberrations at 80 mcg/mL and higher concentrations (equal to the average human exposure to Nabumetone at the maximum recommended dose).

Impairment of Fertility: Nabumetone did not impair fertility of male or female rats treated orally at doses of 320 mg/kg/day (1,888 mg/m2) before mating.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate, well-controlled studies in pregnant women. Nabumetone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus..

Nonteratogenic Effects: Because of the known effects of non-steroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Nabumetone tablets on labor and delivery in pregnant women are unknown.

Nursing Mothers: It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nabumetone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use : Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older). Of the 1,677 patients in US clinical studies who were treated with Nabumetone, 411 patients (24%) were 65 years or older; 22 patients (1%) were 75 years or older. No overall differences in efficacy or safety were observed between these older patients and younger ones. Similar results were observed in a 1 year, non-US postmarketing surveillance study of 10,800 patients treated with Nabumetone, of whom 4,577 patients (42%) were 65 years or older.

• Relafen

• Analgesic, Nonopioid
• Nonsteroidal Anti-inflammatory Drug (NSAID), Oral

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties

Other proposed mechanisms not fully elucidated (and possibly contributing to the anti-inflammatory effect to varying degrees), include inhibiting chemotaxis, altering lymphocyte activity, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels.

Absorption

Well absorbed from GI tract

Distribution

Diffusion occurs readily into synovial fluid; Vdss: 6MNA: 29 to 82 L

Metabolism

Prodrug, rapidly metabolized in the liver to an active metabolite [6-methoxy-2-naphthylacetic acid (6MNA)] and inactive metabolites; extensive first-pass effect; ~35% converted to 6MNA and 50% converted to unidentified metabolites

Excretion

6MNA: Urine (~80%) and feces (9%)

Time to Peak

Serum: 6MNA: Oral: Adults: 2.5 to 3 hours; Elderly: 4 hours

Half-Life Elimination

6MNA: ~24 hours; terminal half-life was increased ~50% in patients with CrCl 30 to 49 mL/minute

Protein Binding

6MNA: >99%

There are no dosage adjustments provided in the manufacturer’s labeling (data limited in severe impairment); use with caution. Prodrug activation and metabolism are hepatic function dependent and may be reduced in severe hepatic impairment.

>10%: Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%)

1% to 10%:

Cardiovascular: Edema (3% to 9%)

Central nervous system: Dizziness (3% to 9%), headache (3% to 9%), drowsiness (1% to 3%), fatigue (1% to 3%), insomnia (1% to 3%), nervousness (1% to 3%)

Dermatologic: Pruritus (3% to 9%), skin rash (3% to 9%), diaphoresis (1% to 3%)

Gastrointestinal: Constipation (3% to 9%), flatulence (3% to 9%), nausea (3% to 9%), occult blood in stools (3% to 9%), gastritis (1% to 3%), stomatitis (1% to 3%), vomiting (1% to 3%), xerostomia (1% to 3%)

Otic: Tinnitus

<1% (Limited to important or life-threatening): Acne vulgaris, agitation, albuminuria, alopecia, anaphylactoid reaction, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, anxiety, asthma, azotemia, bullous rash, cardiac arrhythmia, cardiac failure, chills, cholelithiasis, confusion, cough, depression, duodenal ulcer, duodenitis, dysphagia, dyspnea, dysuria, eosinophilic pneumonitis, eructation, fever, erythema multiforme, gastric ulcer, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, granulocytopenia, hematuria, hepatic failure, hepatic insufficiency, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hyperbilirubinemia, hyperglycemia, hypersensitivity pneumonitis, hypertension, hyperuricemia, hypokalemia, impotence, interstitial nephritis, interstitial pneumonitis, jaundice, leukopenia, malaise, melena, myocardial infarction, nephrolithiasis, nephrotic syndrome, nightmares, palpitations, pancreatitis, paresthesia, pseudoporphyria (cutanea tarda), rectal hemorrhage, renal failure, skin photosensitivity, Stevens-Johnson syndrome, syncope, taste disorder, thrombocytopenia, thrombophlebitis, toxic epidermal necrolysis, tremor, urticaria, vasculitis, vertigo, visual disturbance, weakness, weight gain, weight loss

Applies to nabumetone: oral tablet

Along with its needed effects, nabumetone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nabumetone:

• Headache
• itching skin
• nausea
• rash
• stomach pain
• swelling

• Burning feeling in chest or stomach
• indigestion
• stomach upset
• swelling or inflammation of the mouth
• tenderness in stomach area
• vomiting

• Bleeding gums
• blistering, peeling, loosening of skin
• bloody or black, tarry stools
• bloody or cloudy urine
• burning upper abdominal pain
• changes in vision
• chest pain
• chills
• clay-colored stools
• constipation
• cough
• dark-colored urine
• diarrhea
• difficult or labored breathing
• difficulty swallowing
• dizziness
• dry cough
• dry mouth
• fast heartbeat
• fever
• fluid-filled skin blisters
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• high blood pressure
• hives or welts
• increased sensitivity of skin to sunlight
• increased thirst
• joint pain, stiffness, or swelling
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• light-colored stools
• loss of appetite
• muscle pain
• pain in lower back or side
• pinpoint red spots on skin
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid breathing
• red irritated eyes
• red skin lesions, often with a purple center
• redness or other discoloration of skin
• severe or continuing stomach pain
• severe sunburn
• shortness of breath
• skin thinness
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stomach bloating, burning, or cramping
• swelling of face, fingers, feet or lower legs
• tightness in chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vaginal bleeding
• vomiting of blood or material that looks like coffee grounds
• weight gain or loss
• wheezing
• yellow eyes or skin

• Agitation
• blurred vision
• coma
• confusion
• depression
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• muscle twitching
• nervousness
• pain or discomfort in chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• pounding in the ears
• seizures
• severe stomach pain
• slow heartbeat
• stupor
• unusual drowsiness, dullness, or feeling of sluggishness

Some side effects of nabumetone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• bloated full feeling
• continuing ringing or buzzing or other unexplained noise in ears
• excess air or gas in stomach or intestines
• hearing loss
• indigestion
• mild diarrhea
• passing gas

• Increased sweating
• sleepiness or unusual drowsiness
• sleeplessness
• trouble sleeping
• unable to sleep

• Anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• increased appetite
• lack or loss of strength
• lightheadedness
• sensation of spinning
• shakiness in legs, arms, hands, feet
• trembling or shaking of hands or feet

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:
-Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Diarrhea, dyspepsia, abdominal pain, constipation, flatulence, and nausea are the more common side effects.
• Tinnitus, edema, itchiness and a rash have also been reported.
• Stomach-related adverse effects such as bleeding, ulceration, or perforation. Older patients or those taking other medicines that affect the stomach may be more at risk.
• An increased risk of stroke or heart attack (similar to other NSAIDs). Risk may be higher in patients with pre-existing conditions, in those who drink more than three glasses of alcohol per day and with higher dosages.
• May not be suitable for some people including those with asthma, pre-existing bleeding problems, kidney disease and taking certain medications.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Nabumetone helps relieve pain associated with rheumatoid arthritis or osteoarthritis. It can be taken as a single daily dose and appears less likely to cause stomach-related side effects than some other NSAIDs.

Peak levels are reached 1-2 hours after administration.

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