(Generic versions may still be available.)
Relafen Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Relafen (nabumetone) is a nonsteroidal anti-inflammatory (NSAID) medication. Relafen is used to treat inflammation and pain caused by arthritis. Nonsteroidal anti-inflammatory drugs (including nabumetone) may rarely increase the risk for a heart attack or stroke. Bleeding from the gastrointestinal tract is another potentially serious side effect of Relafen.
Relafen may interact with other drugs, including aspirin, certain diuretics, ACE-inhibitors, lithium (Eskalith, Lithobid), methotrexate (Rheumatrex, Trexall), and warfarin (Coumadin). There are no adequate, well-controlled studies in pregnant women, and Relafen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Use during late pregnancy should be avoided because of the known effects of NSAIDs in the fetal cardiovascular system (closure of ductus arteriosus). It is not known whether Relafen is excreted in human milk; a decision should be made whether to discontinue nursing or to discontinue the Relafen.
Our Relafen Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Relafen in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Relafen (Nabumetone)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Relafen Overview - Patient Information: Side Effects
Upset stomach, nausea, vomiting, constipation, diarrhea, gas, dizziness, drowsiness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands or feet (edema), sudden or unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing, unusual tiredness.
Get medical help right away if any of these rare but very serious side effects occur: change in the amount of urine, unexplained stiff neck.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking nabumetone and consult your doctor or pharmacist immediately: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Relafen (Nabumetone)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Relafen FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Relafen (Nabumetone)
Additional Relafen Information
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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.
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