Relafen

DRUG DESCRIPTION

RELAFEN (nabumetone) is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure:

Relafen (nabumetone) structural formula illustration

Nabumetone is a white to off-white crystalline substance with a molecular weight of 228.3. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol: phosphate buffer partition coefficient of 2400 at pH 7.4.

Tablets for Oral Administration: Each oval-shaped, film-coated tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients consist of hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide. The 750-mg tablets also contain iron oxides.

What are the possible side effects of nabumetone (Relafen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking nabumetone and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight...

Read All Potential Side Effects and See Pictures of Relafen

What are the precautions when taking nabumetone (Relafen)?

See also Warning section.

Before taking nabumetone, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having...

Read All Potential Precautions of Relafen


Relafen Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, constipation, diarrhea, gas, dizziness, drowsiness, fatigue, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands or feet (edema), sudden or unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing.

Get medical help right away if any of these rare but very serious side effects occur: change in the amount of urine, unexplained stiff neck.

This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking nabumetone and consult your doctor or pharmacist immediately: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin, unusual/extreme tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking nabumetone, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney effects.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Relafen Patient Information Including Side Effects

Brand Names: Relafen

Generic Name: nabumetone (Pronunciation: na BUE me tone)

  • What is nabumetone (Relafen)?
  • What are the possible side effects of nabumetone (Relafen)?
  • What is the most important information I should know about nabumetone (Relafen)?
  • What should I discuss with my healthcare provider before taking nabumetone (Relafen)?
  • How should I take nabumetone (Relafen)?
  • What happens if I miss a dose (Relafen)?
  • What happens if I overdose (Relafen)?
  • What should I avoid while taking nabumetone (Relafen)?
  • What other drugs will affect nabumetone (Relafen)?
  • Where can I get more information?

What is nabumetone (Relafen)?

Nabumetone is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Nabumetone is used to treat pain or inflammation caused by arthritis.

Nabumetone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nabumetone (Relafen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking nabumetone and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation;
  • bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • blurred vision; 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nabumetone (Relafen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use nabumetone. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking nabumetone. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to nabumetone (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking nabumetone. Alcohol can increase the risk of stomach bleeding caused by nabumetone.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Nabumetone can make your skin more sensitive to sunlight and sunburn may result.

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