Relafen

What Is Relafen?

Relafen (nabumetone) is a nonsteroidal anti-inflammatory (NSAID) drug used to treat inflammation and pain caused by arthritis. The brand name drug Relafen is no longer available in the U.S. Generic versions may be available.

What Are Side Effects of Relafen?

Side effects of Relafen include:

• upset stomach,
• heartburn,
• stomach pain,
• diarrhea,
• constipation,
• bloating,
• gas,
• dizziness,
• headache,
• nervousness,
• skin itching or rash,
• blurred vision, or
• ringing in your ears.

Nonsteroidal anti-inflammatory drugs (including Relafen) may rarely increase the risk for a heart attack or stroke. Bleeding from the gastrointestinal tract is another potentially serious side effect of Relafen.

What Drugs, Substances, or Supplements Interact with Relafen?

Relafen may interact with antidepressants, blood thinners, lithium, methotrexate, diuretics (water pills), steroids, aspirin or other NSAIDs, or ACE inhibitors.

Relafen During Pregnancy and Breastfeeding

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 breastfeeding or to discontinue the Relafen.

Additional Information

Our Relafen Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Relafen Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using nabumetone and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• stomach pain, indigestion, nausea;
• diarrhea, constipation, gas;
• swelling in your hands and feet;
• headache, dizziness;
• itching, skin rash; 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.

Read the entire detailed patient monograph for Relafen (Nabumetone)

 

Relafen Professional 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.

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*.

*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.

†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)