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Relafen Side Effects

Generic Name: nabumetone

Note: This document contains side effect information about nabumetone. Some of the dosage forms listed on this page may not apply to the brand name Relafen.

For the Consumer

Applies to nabumetone: oral tablet

Along with its needed effects, nabumetone (the active ingredient contained in Relafen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nabumetone:

More Common

Less Common

Rare

  • Bleeding gums
  • blistering, peeling, loosening of skin
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • burning upper abdominal pain
  • changes in vision
  • chest pain
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark-colored urine
  • diarrhea
  • difficult or labored breathing
  • difficulty swallowing
  • dizziness
  • dry cough
  • dry mouth
  • fast heartbeat
  • fever
  • fluid-filled skin blisters
  • general feeling of tiredness or weakness
  • greatly decreased frequency of urination or amount of urine
  • high blood pressure
  • hives or welts
  • increased sensitivity of skin to sunlight
  • increased thirst
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • light-colored stools
  • loss of appetite
  • muscle pain
  • pain in lower back or side
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid breathing
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness or other discoloration of skin
  • severe or continuing stomach pain
  • severe sunburn
  • shortness of breath
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stomach bloating, burning, or cramping
  • swelling of face, fingers, feet or lower legs
  • tightness in chest
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting of blood or material that looks like coffee grounds
  • weight gain or loss
  • wheezing
  • yellow eyes or skin

Symptoms of Overdose

  • Agitation
  • blurred vision
  • coma
  • confusion
  • depression
  • hostility
  • irregular, fast or slow, or shallow breathing
  • irritability
  • muscle twitching
  • nervousness
  • pain or discomfort in chest, upper stomach, or throat
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • seizures
  • severe stomach pain
  • slow heartbeat
  • stupor
  • unusual drowsiness, dullness, or feeling of sluggishness

Some side effects of nabumetone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Acid or sour stomach
  • belching
  • bloated full feeling
  • continuing ringing or buzzing or other unexplained noise in ears
  • excess air or gas in stomach or intestines
  • hearing loss
  • indigestion
  • mild diarrhea
  • passing gas

Less Common

  • Increased sweating
  • sleepiness or unusual drowsiness
  • sleeplessness
  • trouble sleeping
  • unable to sleep

Rare

  • Anxiety
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • increased appetite
  • lack or loss of strength
  • lightheadedness
  • sensation of spinning
  • shakiness in legs, arms, hands, feet
  • trembling or shaking of hands or feet

For Healthcare Professionals

Applies to nabumetone: oral tablet

Gastrointestinal

Very common (10% or more): Diarrhea (14%), dyspepsia (13%), abdominal pain (12%)

Common (1% to 10%): Constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting

Uncommon (0.1% to 1%): Duodenal ulcer, GI bleeding, gastric ulcer, GI disorder, melena, stomatitis

Very rare (less than 0.01%): Pancreatitis

Frequency not reported: Anorexia, dysphagia, gastroenteritis, duodenitis, eructation, glossitis, rectal bleeding[Ref]

Hepatic

Uncommon (0.1% to 1%): Elevated liver function tests

Very rare (less than 0.01%): Hepatic failure, jaundice

Frequency not reported: Liver function abnormalities, gallstones[Ref]

Renal

Very rare (less than 0.01%): Renal failure, nephrotic syndrome

Frequency not reported: Albuminuria, azotemia, interstitial nephritis, renal stones[Ref]

Dermatologic

Common (1% to 10%): Sweating increased, pruritus, rash

Uncommon (0.1% to 1%): Photosensitivity, urticaria

Very rare (less than 0.01%): Bullous eruptions, pseudoporphyria cutanea tarda, acne, alopecia, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, angioedema

Frequency not reported: Purpura[Ref]

Hematologic

Very rare (less than 0.01%): Thrombocytopenia

Frequency not reported: Anemia, leukopenia, granulocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactoid reaction, anaphylaxis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, somnolence

Uncommon (0.1% to 1%): Paresthesia

Frequency not reported: Tremor, syncope, drowsiness[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness

Uncommon (0.1% to 1%): Confusion, anxiety

Frequency not reported: Agitation, depression, nightmares, hallucinations[Ref]

Cardiovascular

Common (1% to 10%): Hypertension/blood pressure increased

Frequency not reported: Vasculitis, angina, arrhythmia, myocardial infarction, palpitations, thrombophlebitis, cardiac failure[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, respiratory disorder, epistaxis

Very rare (less than 0.01%): Interstitial pneumonitis

Frequency not reported: Asthma, cough, aggravated asthma, bronchospasm

Postmarketing reports: Eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis[Ref]

Other

Common (1% to 10%): Fatigue, tinnitus, edema, ear disorder

Uncommon (0.1% to 1%): Asthenia, fatigue

Frequency not reported: Malaise, vertigo, weight gain, gingivitis, taste disorder, fever, chills, weight loss, aseptic meningitis[Ref]

Cases of aseptic meningitis have been reported, especially in patients with autoimmune disorders, such as systemic lupus erythematosus or mixed connective tissue disease. Symptoms have included stiff neck, headache, nausea, vomiting, fever, and disorientation.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract disorder

Very rare (less than 0.01%): Menorrhagia

Frequency not reported: Bilirubinuria, dysuria, hematuria, impotence

Postmarketing reports: Vaginal bleeding[Ref]

Metabolic

Frequency not reported: Appetite increased, hyperglycemia, hypokalemia

Postmarketing reports: Hyperuricemia[Ref]

General

The most frequently reported adverse effects were gastrointestinal (GI) in nature and included diarrhea, dyspepsia, and abdominal pain.[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myopathy[Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision, eye disorder

Frequency not reported: Optic neuritis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Relafen (nabumetone)." SmithKline Beecham, Philadelphia, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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