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.
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.
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.
If any of the following side effects occur while taking nabumetone, check with your doctor immediately:More common
- itching skin
- stomach pain
- Burning feeling in chest or stomach
- stomach upset
- swelling or inflammation of the mouth
- tenderness in stomach area
- 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
- clay-colored stools
- dark-colored urine
- difficult or labored breathing
- difficulty swallowing
- dry cough
- dry mouth
- fast heartbeat
- 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
- yellow eyes or skin
- blurred vision
- irregular, fast or slow, or shallow breathing
- muscle twitching
- pain or discomfort in chest, upper stomach, or throat
- pale or blue lips, fingernails, or skin
- pounding in the ears
- severe stomach pain
- slow heartbeat
- unusual drowsiness, dullness, or feeling of sluggishness
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
- bloated full feeling
- continuing ringing or buzzing or other unexplained noise in ears
- excess air or gas in stomach or intestines
- hearing loss
- mild diarrhea
- passing gas
- Increased sweating
- sleepiness or unusual drowsiness
- trouble sleeping
- unable to sleep
- 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
- sensation of spinning
- shakiness in legs, arms, hands, feet
- trembling or shaking of hands or feet
For Healthcare Professionals
Applies to nabumetone: oral tablet
In a study designed to measure gastrointestinal blood loss associated with the oral administration of nabumetone (the active ingredient contained in Relafen) aspirin, or placebo in healthy volunteers, nabumetone was not statistically different from placebo while aspirin was associated with significant gastrointestinal microbleeding. In addition, endoscopy studies have confirmed a reduced incidence of gastropathy associated with nabumetone compared to other nonsteroidal anti-inflammatory agents.
In a follow-up study involving 1,677 patients treated with nabumetone for up to 8 years, serious gastrointestinal side effects such as ulceration, bleeding, and/or perforation, occurred in 16 patients, representing a cumulative incidence of 0.95%.
Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Nabumetone should be used with caution in these patients.
Gastrointestinal side effects have been reported the most frequently. These have included diarrhea (14%), dyspepsia (13%), and abdominal pain (12%). Between 3% to 9% of patients have reported nausea, constipation, positive stool guaiac, and flatulence. Adverse effects occurring in less than 3% of the patients have included dry mouth, gastritis, stomatitis, vomiting, anorexia, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, and increased appetite. Despite the fact that nabumetone is a nonacidic prodrug, and as such, has a decreased propensity for causing gastric mucosal damage, serious gastrointestinal side effects, such as bleeding, ulceration, and perforation have been reported in up to 0.95% of patients.
Elevations in serum transaminases three times normal values are reported in less than 1% of patients treated with nabumetone (the active ingredient contained in Relafen) Serious hepatotoxicity, including fatal fulminant hepatitis, is reported with other nonsteroidal anti-inflammatory agents. Patients with signs or symptoms of hepatic dysfunction or who develop significant elevations in serum transaminases during nabumetone therapy should be evaluated for evidence of more serious hepatotoxicity.
Hepatic side effects have included borderline elevations in liver function tests in up to 15% of patients as well as rare cases of cholestatic jaundice. Due to this patient's liver disease, cautious use of nabumetone and frequent monitoring of liver function tests during therapy is recommended.
Renal side effects have included albuminuria, azotemia, nephrotic syndrome, and interstitial nephritis, as well as rare reports of renal failure, dysuria, hematuria, and renal stones. A fatal case of acute renal failure has also been reported. Due to this patient's liver disease, cautious use of nabumetone (the active ingredient contained in Relafen) and frequent monitoring of liver function tests during therapy is recommended.
Nabumetone may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for nabumetone-induced renal insufficiency are advanced age and concomitant use of diuretics.
A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
Dermatologic side effects have included rash (6.9%) and pruritus (3.9%). Acne, alopecia, bullous eruptions, photosensitivity, pseudoporphyria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.
Pseudoporphyria was diagnosed in two patients after approximately 16 months of nabumetone therapy. Skin fragility persisted for longer than 12 months. High factor sunscreens were used on these patients.
Hematologic side effects have rarely included iron deficiency anemia, aplastic anemia, thrombocytopenia, granulocytopenia, and leukopenia.
Hypersensitivity side effects have included anaphylactoid reactions, anaphylaxis, facial itching, angioedema, urticaria, and bronchospasm.
Nervous system side effects have included headache (9.2%) and dizziness (5.7%). Asthenia, fatigue, insomnia, nervousness, somnolence, tremor, agitation, anxiety, confusion, depression, malaise, vertigo, and nightmares have also been reported.
Psychiatric side effects have included rare reports of agitation, anxiety, and depression.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive mediations in patients already being treated with antihypertensive drugs.
Cardiovascular side effects have included vasculitis. Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, and thrombophlebitis have also been reported.
Pulmonary fibrosis was reported in a 68-year-old female with osteoarthritis and osteoporosis treated with nabumetone (the active ingredient contained in Relafen) 1500 mg per day. Symptoms of shortness of breath and dry cough began within 2 weeks of initiation of therapy, and progressed over a course of 6 weeks until the diagnosis of drug-induced pulmonary fibrosis was made. Treatment, consisting of corticosteroids and discontinuation of nabumetone, resulted in rapid resolution of physical signs and symptoms.
Respiratory side effects have rarely included dyspnea, asthma, cough, idiopathic interstitial pneumonitis, eosinophilic pneumonia, and hypersensitivity pneumonitis. A case of pulmonary fibrosis has also been reported.
Other side effects have included tinnitus (3.9%), abnormal vision, taste disorder, fever, and chills.
Genitourinary side effects have included albuminuria, azotemia, hematuria, dysuria, hyperuricemia, impotence interstitial nephritis, nephrotic syndrome, renal stones, and vaginal bleeding.
Metabolic side effects have included weight loss, hyperglycemia, and hypokalemia.
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