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Does Relafen (nabumetone) cause side effects?
NSAIDs are used to manage mild to moderate pain, fever, and inflammation. They work by reducing the levels of prostaglandins, chemicals produced by the body that are responsible for pain, fever and inflammation. NSAIDs block the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins.
As a consequence, inflammation, pain and fever are reduced. The brand name drug Relafen is no longer available in the U.S.
Common side effects of Relafen include
Serious side effects of Relafen include
- serious gastrointestinal bleeding (signs may include black, tarry stools, weakness, and dizziness upon standing),
- liver toxicity,
- kidney impairment,
- increased bleeding after an injury,
- rare but severe allergic reactions (particularly in patients with a history of exacerbation of asthma, hives, or other allergic reactions to aspirin or other NSAIDs),
- fluid retention (edema),
- blood clots,
- heart attacks,
- high blood pressure (hypertension), and
- heart failure
- The concomitant administration of Relafen and aspirin is not generally recommended because of the potential of increased adverse effects.
- Relafen can reduce the natriuretic effect of furosemide and thiazides in some patients.
- NSAIDs have produced an elevation of plasma lithium levels and a reduction in lithium clearance via the kidneys.
- NSAIDs could enhance the toxicity of methotrexate.
- Users of both warfarin and NSAIDs together have a risk of serious gastrointestinal bleeding higher than users of either drug alone.
In late pregnancy, as with other NSAIDs, Relafen should be avoided because it may cause premature closure of the ductus arteriosus.
What are the important side effects of Relafen (nabumetone)?
Most patients, benefit from nabumetone and other NSAIDs with few side effects. However, serious side effects can occur, and generally tend to be dose-related. Therefore, it is advisable to use the lowest effective dose to minimize side effects. The most common side effects of nabumetone involve the gastrointestinal system, and these include:
Sometimes ulceration and bleeding can occur without any abdominal pain. Black, tarry stools, weakness, and dizziness upon standing may be the only signs of internal bleeding. Some studies have shown that nabumetone may have a lower risk of gastrointestinal side effects than the other NSAID medications.
Other important side effects caused by nabumetone include:
NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury. Nabumetone should be avoided by patients with a history of exacerbation of asthma, hives, or other allergic reactions to aspirin or other NSAIDs. Rare but severe allergic reactions have been reported in such individuals. Fluid retention (edema), blood clots, heart attacks, hypertension and heart failure have also been associated with the use of NSAIDs.
Relafen (nabumetone) side effects list for healthcare professionals
Adverse reaction information was derived from blinded-controlled and open-labelled 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 US clinical studies.
Of the 1,677 patients who received Relafen (nabumetone) during US 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. More than 300 patients have been treated for 5 years or longer.
Incidence ≥ 1%-Probably Causally Related
Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%),
constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis,
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.
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.
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.
What drugs interact with Relafen (nabumetone)?
- 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 Relafen (nabumetone) is administered with aspirin, its protein binding is reduced, although the clearance of free Relafen (nabumetone) is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of nabumetone 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 Relafen (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, 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 Relafen (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.
Relafen (nabumetone) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat inflammation and pain from rheumatoid arthritis and osteoarthritis. Common side effects of Relafen include abdominal pain, cramping, nausea, gastritis, rash, and ringing in the ears. In late pregnancy, as with other NSAIDs, Relafen should be avoided because it may cause premature closure of the ductus arteriosus. It is unknown if Relafen is excreted in breast milk. Consult your doctor before breastfeeding.
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Related Disease Conditions
Buildup of uric acid crystals in a joint causes gouty arthritis. Symptoms and signs include joint pain, swelling, heat, and redness, typically of a single joint. Gout may be treated with diet and lifestyle changes, as well as medication.
Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. The 16 characteristic early RA signs and symptoms include the following. Anemia Both sides of the body affected (symmetric) Depression Fatigue Fever Joint deformity Joint pain Joint redness Joint stiffness Joint swelling Joint tenderness Joint warmth Limping Loss of joint function Loss of joint range of motion Many joints affected (polyarthritis)
16 Early Signs and Symptoms of Rheumatoid Arthritis (RA)
Early RA symptoms and signs vary differently from person to person. The most common body parts that are initially affected by RA include the small joints of the hands, wrists, and feet, and the knees and hip joints. Joint inflammation causes stiffness. Warmth, redness, and pain may vary in degree.
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Also known as degenerative arthritis, osteoarthritis can be caused by aging, heredity, and injury from trauma or disease.
Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms and signs include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves anti-inflammatory medications and exercise.
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Pain Management and Rheumatoid Arthritis
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Rheumatoid Arthritis vs. Fibromyalgia
Though rheumatoid arthritis (RA) and fibromyalgia have similar symptoms, RA is an autoimmune disease and fibromyalgia is a chronic pain syndrome. RA symptoms include joint redness, swelling, and pain that lasts more than six weeks. Fibromyalgia symptoms include widespread pain, tingling feet or hands, depression, and bowel irritability. Home remedies for both include stress reduction, exercise, and getting enough sleep.
Fungal arthritis is inflammation of a joint by a fungus that has invaded the body and is growing in the normally sterile joint. Symptoms and signs include pain, redness, loss of range of motion, and swelling. Fungal arthritis is treated with antibiotics.
Osteoarthritis vs. Osteoporosis Differences and Similarities
Arthritis is defined as painful inflammation and joint stiffness. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. Osteoarthritis is a type of arthritis that involves the entire joint. Osteoporosis is not a type of arthritis. It is a disease that mainly is caused by a loss of bone tissue that is not limited to the joint areas. It is possible for one person to have both osteoarthritis and osteoporosis. The differences in the signs and symptoms of osteoarthritis and osteoporosis include; pain, stiffness, and joint swelling, joint deformity, crackle sounds when the joint is moving, and walking with a limp. Osteoporosis is called the "silent disease" because it can progress for years without signs and symptoms before it is diagnosed, severe back pain, bone fractures, height loss, and difficulty or inability to walk. The differences in the causes of osteoarthritis and osteoporosis are that osteoarthritis usually is caused by wear and tear on the joints. Osteoporosis usually is caused by one or more underlying problems, for example, calcium and vitamin D deficiencies. Treatment for osteoarthritis and osteoporosis are not the same. There is no cure for osteoarthritis or osteoporosis.
Which Foods Make Arthritis Worse?
Certain foods can contribute to arthritis joint inflammation, like processed foods high in salt, alcohol, red meat and others. Foods that are good for the joints are beans, greens and other whole foods that have high fiber and nutrient content and low calories; these foods promote weight loss, which improves arthritis symptoms, and some may lower inflammation, generally.
Osteoarthritis vs. Rheumatoid Arthritis
Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic joint disorders. RA is also an autoimmune disease. OA and RA symptoms and signs include joint pain, warmth, and tenderness. Over-the-counter pain relievers treat both diseases. There are several prescription medications that treat RA.
What Is the Main Cause of Rheumatoid Arthritis?
Rheumatoid arthritis is a chronic inflammatory disease characterized by pain and inflammation in joints, typically of the hands and feet. It is an autoimmune disease in which the immune system of the body attacks its own healthy cells, resulting in inflammation of the membrane lining the joints and damage to joint tissue.
Rheumatoid Arthritis vs. Arthritis
Arthritis is a general term used to describe joint disease. Rheumatoid arthritis (RA) is a type of arthritis in which the body’s immune system mistakenly attacks the joints, causing chronic inflammation.
How Serious Is Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is a chronic inflammatory disorder that typically affects the joints and other body parts, such as the skin, eyes, lungs, heart and blood vessels. RA is an autoimmune disorder, a condition where the body’s immune system attacks its own tissues. If not diagnosed early and appropriately treated, RA can lead to permanent deformities, disabilities and serious systemic complications.
Can Rheumatoid Arthritis Affect Pregnancy?
Yes, rheumatoid arthritis (RA) affects pregnancy. RA can lead to complications like preterm birth, raised blood pressure (preeclampsia), and low birth weight babies.
Safest Rheumatoid Arthritis Drugs During Pregnancy
None of the drugs used in the treatment of rheumatoid arthritis (RA) is completely safe during pregnancy. You must discuss with your physician regarding the decision to use, modify, or stop any medications.
Breastfeeding With Rheumatoid Arthritis
You can breastfeed your baby even if you have rheumatoid arthritis (RA). However, you must always consult your doctor before you start the process.
What Is the Main Cause of Osteoarthritis?
Osteoarthritis (OA) is a chronic degenerative disease of the joints affecting middle-aged and elderly people. It involves the breakdown of cartilage and associated inflammatory changes in the adjacent bone. It is a leading cause of chronic disability, affecting 30 million people in the United States alone.
Causes of Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an autoimmune disorder (the body’s immune system mistakenly attacks its own cells). Certain factors increase the risk of RA.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.