Sulindac is a nonsteroidal anti-inflammatory drug (NSAID).

Sulindac is used to treat pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, or gout.

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

Sulindac can increase your risk of fatal heart attack or stroke. Do not use sulindac just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Sulindac may also cause stomach or intestinal bleeding, which can be fatal.

Sulindac comes as a tablet to take by mouth. It is usually taken with food twice a day. Take sulindac at around the same times each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sulindac exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sulindac helps control arthritis pain but does not cure arthritis. If you are taking sulindac to treat arthritis pain, it may take 1 week or longer before you feel the full benefit of sulindac.

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

Take sulindac with food.

If you use sulindac 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.

Sulindac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

You should not use sulindac 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.

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;

• kidney disease kidney stones;

• liver disease;

• a pancreas disorder;

• asthma;

• fluid retention; or

• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take sulindac unless your doctor tells you to. Taking an 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.

You should not breastfeed while using this medicine.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Avoid taking aspirin or other NSAIDs, unless your doctor tells you to.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to sulindac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny 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.

Sulindac may cause serious side effects. Stop using sulindac and call your doctor at once if you have:

• changes in your vision;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• 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);

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• 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 side effects of sulindac may include:

• nausea, vomiting, stomach pain, indigestion, loss of appetite;

• diarrhea, constipation, gas;

• headache, dizziness, nervousness;

• itching, 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 sulindac if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• lithium;

• methotrexate;

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

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

• oral diabetes medication; or

• steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect sulindac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.