Relafen Side Effects
Generic name: nabumetone
Medically reviewed by Drugs.com. Last updated on Dec 24, 2023.
Note: This document provides detailed information about Relafen Side Effects associated with nabumetone. Some dosage forms listed on this page may not apply specifically to the brand name Relafen.
Applies to nabumetone: oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a longer time.
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (eg, steroid medicine, blood thinner).
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Some possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, or vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires medical attention. It may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Relafen
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 side effects
- headache
- itching, skin rash
- nausea
- stomach pain
- swelling
Less common side effects
- burning feeling in the chest or stomach
- indigestion
- stomach tenderness or upset
- swelling or inflammation of the mouth
- vomiting
Rare side effects
- 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
Other side effects of Relafen
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 side effects
- 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 side effects
- increased sweating
- sleepiness or unusual drowsiness
- trouble sleeping
Rare side effects
- 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.
General adverse events
The most frequently reported adverse effects were gastrointestinal (GI) in nature and included diarrhea, dyspepsia, and abdominal pain.[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]
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]
Musculoskeletal
- Uncommon (0.1% to 1%): Myopathy[Ref]
Ocular
- Uncommon (0.1% to 1%): Abnormal vision, eye disorder
- Frequency not reported: Optic neuritis[Ref]
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References
1. (2001) "Product Information. Relafen (nabumetone)." SmithKline Beecham
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
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Further information
Relafen side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.