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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.
Read the Relafen (nabumetone) Side Effects Center for a complete guide to possible side effects
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 (see PRECAUTIONS, 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 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 (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Read the Relafen Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/8/2007
This monograph has been modified to include the generic and brand name in many instances.
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