Relafen Side Effects

Generic name: nabumetone

Note: This page contains side effects data for the generic drug nabumetone. It is possible that some of the dosage forms included below may not apply to the brand name Relafen.

For the Consumer

Applies to nabumetone: oral tablet

As well as its needed effects, nabumetone (the active ingredient contained in Relafen) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking nabumetone, check with your doctor immediately:

More common:

• Headache
• itching skin
• nausea
• rash
• stomach pain
• swelling

Less common:

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

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

Minor Side Effects

Some nabumetone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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]

It is possible that some side effects of Relafen may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.