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Relafen DS Side Effects

Generic name: nabumetone

Medically reviewed by Drugs.com. Last updated on Aug 14, 2021.

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 DS.

For the Consumer

Applies to nabumetone: oral tablet

Warning

Oral route (Tablet)

NSAIDs cause an increased risk of serious or fatal cardiovascular thrombotic events, myocardial infarction, and stroke. Nabumetone is contraindicated in the setting of CABG surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Side effects requiring immediate medical attention

Along with its needed effects, nabumetone (the active ingredient contained in Relafen DS) 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

  • Burning feeling in the chest or stomach
  • indigestion
  • stomach tenderness or upset
  • swelling or inflammation of the mouth
  • vomiting

Rare

  • Bleeding gums
  • blistering, peeling, loosening of the skin
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • burning upper abdominal or stomach pain
  • changes in vision
  • chest pain or tightness
  • chills
  • clay-colored stools
  • constipation
  • cough
  • dark-colored urine
  • diarrhea
  • difficulty swallowing
  • dizziness
  • dry cough
  • dry mouth
  • fast heartbeat
  • fever
  • fluid-filled skin blisters
  • greatly decreased frequency of urination or amount of urine
  • hives or welts
  • increased sensitivity of the skin to sunlight
  • increased thirst
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle pain
  • pinpoint red spots on the 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 the skin
  • severe sunburn
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach bloating, burning, cramping, or pain
  • swelling of the face, fingers, feet or lower legs
  • trouble breathing
  • 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
  • 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 the 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

Side effects not requiring immediate medical attention

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 the ears
  • excess air or gas in the stomach or intestines
  • hearing loss
  • indigestion
  • mild diarrhea
  • passing gas

Less common

  • Increased sweating
  • sleepiness or unusual drowsiness
  • trouble sleeping

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
  • trembling or shaking of the legs, arms, 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

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]

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]

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

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

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.