Relafen DS Side Effects
Generic name: nabumetone
Medically reviewed by Drugs.com. Last updated on Dec 24, 2023.
Note: This document provides detailed information about Relafen DS Side Effects associated with nabumetone. Some dosage forms listed on this page may not apply specifically to the brand name Relafen DS.
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.
Serious side effects of Relafen DS
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 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 DS
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]
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 DS 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.
Some side effects may not be reported. You may report them to the FDA.