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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Nabumetone:Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.
TopSevere 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.
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. More than 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
GastrointestinalDiarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*2, flatulence*2, nausea*2, positive stool guaiac*2, dry mouth, gastritis, stomatitis, vomiting.
Central Nervous SystemDizziness*2, headache*2, fatigue, increased sweating, insomnia, nervousness, somnolence.
Dermatologic Special SensesTinnitus*2.
MiscellaneousEdema*2.
- 2
- * Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.
Incidence < 1% - Probably Causally Related†3
GastrointestinalAnorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.
Central Nervous SystemAsthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.
DermatologicBullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermalnecrolysis, erythema multiforme, Stevens-Johnson syndrome.
CardiovascularVasculitis.
MetabolicWeight Gain.
RepiratoryDyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.
GenitourinaryAlbuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginalbleeding, renal failure.
Special SensesAbnormal vision.
Hematologic/LymphaticThrombocytopenia.
HypersensitivityAnaphylactoid reaction, anaphylaxis, angioneurotic edema.
- 3
- † 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
GastrointestinalBilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.
Central Nervous SystemNightmares.
DermatologicAcne, alopecia.
CardiovascularAngina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.
RespiratoryAsthma, cough.
GenitourinaryDysuria, hematuria, impotence, renal stones.
Special SensesTaste disorder.
Body as a WholeFever, chills.
Hematologic/LymphaticAnemia, leukopenia, granulocytopenia.
Metabolic/NutritionalHyperglycemia, hypokalemia, weight loss.
TopNabumetone Tablets
Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from world-wide 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. More than 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*
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*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
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†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
TopMore resources:
Nabumetone - Includes detailed dosage instructions.
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