Relafen

Name: Relafen

Notes

Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

Relafen Overview

Relafen is a prescription medication used to relieve the pain and swelling of osteoarthritis and rheumatoid arthritis. Relafen belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs), which work by stopping substances in your body that cause inflammation and pain.

This medication comes in tablet form and is taken once or twice daily, with or without food.

Common side effects include diarrhea, stomach pain, and constipation.

Relafen can cause dizziness. Do not drive or operate heavy machinery until you know how Relafen will affect you.

Side Effects of Relafen

Serious side effects have been reported with Relafen. See “Drug Precautions” section.

Common side effects of Relafen include:

  • diarrhea
  • constipation
  • gas or bloating
  • dizziness
  • headache
  • dry mouth
  • sores in the mouth
  • nervousness
  • difficulty falling asleep or staying asleep
  • increased sweating
  • ringing in the ears

This is not a complete list of Relafen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What should I discuss with my healthcare provider before taking nabumetone?

Nabumetone can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Nabumetone may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using nabumetone, especially in older adults.

You should not use nabumetone if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure nabumetone is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • asthma;

  • liver or kidney disease; or

  • fluid retention.

Taking nabumetone during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether nabumetone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Nabumetone is not approved for use by anyone younger than 18 years old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I avoid while taking nabumetone?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking nabumetone.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to nabumetone. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or tanning beds. Nabumetone can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect nabumetone?

Ask your doctor before using nabumetone if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • lithium;

  • methotrexate;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or "water pill"; or

  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with nabumetone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Relafen Side Effects

Along with its needed effects, a medicine 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:

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

Some side effects 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Indications and Usage for Relafen

Carefully consider the potential benefits and risks of Relafen and other treatment options before deciding to use RELAFEN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

RELAFEN is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Adverse Reactions

Adverse reaction information was derived from blinded-controlled and open-labelled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies.

Of the 1,677 patients who received Relafen during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer.

The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.

Incidence≥1%Probably Causally Related

Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation*, flatulence*, nausea*, positive stool guaiac*, dry mouth, gastritis, stomatitis, vomiting.

Central Nervous System: Dizziness*, headache*, fatigue, increased sweating, insomnia, nervousness, somnolence.

Dermatologic: Pruritus*, rash*.

Special Senses: Tinnitus*.

Miscellaneous: Edema*.

*Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked.

Incidence <1%Probably Causally Related†

Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure.

Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo.

Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Cardiovascular: Vasculitis.

Metabolic: Weight gain.

Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis.

Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure.

Special Senses: Abnormal vision.

Hematologic/Lymphatic:Thrombocytopenia.

Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioneurotic edema.

†Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized.

Incidence <1%Causal Relationship Unknown

Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding.

Central Nervous System: Nightmares.

Dermatologic: Acne, alopecia.

Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis.

Respiratory: Asthma, cough.

Genitourinary: Dysuria, hematuria, impotence, renal stones.

Special Senses: Taste disorder.

Body as a Whole: Fever, chills.

Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia.

Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.

Overdosage

Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

There have been overdoses of up to 25 grams of Relafen reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H2-blockers, etc.).

Relafen side effects

Get emergency medical help if you have signs of an allergic reaction to Relafen: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Relafen and call your doctor at once if you have:

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Relafen side effects may include:

  • stomach pain, indigestion, nausea;

  • diarrhea, constipation, gas;

  • swelling in your hands and feet;

  • headache, dizziness;

  • itching, skin rash; or

  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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]

Some side effects of Relafen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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