Relafen is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Relafen is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

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

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

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

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 Relafen (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 Relafen. Alcohol can increase the risk of stomach bleeding caused by nabumetone. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Relafen can make your skin more sensitive to sunlight and sunburn may result.

Take Relafen exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

You may take Relafen with or without food.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Usual Adult Dose for Osteoarthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

Relafen 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).

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

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

To make sure Relafen is safe for you, tell your doctor if you have ever had:

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

• a heart attack, stroke, or blood clot;

• stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• fluid retention.

If you are pregnant, you should not take Relafen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Relafen is not FDA-approved for use by anyone younger than 18 years old.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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 Relafen. 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. Relafen can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Relafen: (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

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.

Ask your doctor before using Relafen 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 (examples: warfarin, Coumadin, Jantoven, apixaban, dabigatran, rivaroxaban);

• 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.