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

Indomethacin is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis. Indomethacin is also used to treat shoulder pain caused by bursitis or tendinitis.

Extended-release indomethacin (Indocin SR) should not be used to treat gouty arthritis.

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

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

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

Indomethacin comes as a capsule, an extended-release (long-acting) capsule, and a suspension to take by mouth. Indomethacin capsules and liquid usually are taken two to four times a day. Extended-release capsules are usually taken one or two times a day. Indomethacin capsules, extended-release capsules, and suspension should be taken with food, immediately after meals, or with antacids. Take indomethacin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take indomethacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release capsules whole; do not split, chew, or crush them.

Shake the suspension well before each use to mix the medication evenly.

Your doctor may change the dose of your medication during your treatment. In some cases, your doctor may start you on a low dose of indomethacin and gradually increase your dose, not more often than once a week. In other cases, your doctor may start you on an average dose of indomethacin and decrease your dose once your symptoms are controlled. Follow these directions carefully and ask your doctor or pharmacist if you have any questions.

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

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your dose needs may change if you switch to a different brand, strength, or form of indomethacin. Avoid medication errors by using only the form and strength your doctor prescribes.

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

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Indomethacin 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).

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

You should not use indomethacin 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;

• a heart attack, stroke, or blood clot;

• fluid retention;

• bleeding problems;

• stomach ulcers or bleeding;

• asthma;

• liver or kidney disease; or

• if you smoke.

If you are pregnant, you should not take indomethacin 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.

This medicine may temporarily affect fertility (ability to have children) in women.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Indomethacin is not approved for use by anyone younger than 14 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.

Overdose symptoms may include severe drowsiness, stomach pain, or vomiting.

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 alcohol. Heavy drinking can increase your risk of stomach bleeding.

Avoid taking aspirin 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 indomethacin (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction (hives, 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, leg swelling, feeling short of breath.

Stop using indomethacin and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

• a skin rash, no matter how mild;

• changes in your vision;

• heart problems--swelling, rapid weight gain, feeling short of breath;

• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, diarrhea, unusual tiredness, itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);

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

• kidney problems--little or no 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 indomethacin may include:

• indigestion, nausea;

• headache; or

• dizziness.

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 indomethacin if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using indomethacin with any other medications, especially:

• cyclosporine;

• lithium;

• methotrexate;

• probenecid;

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

• a blood thinner--warfarin, Coumadin, Jantoven; or

• other NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, meloxicam, and others.

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking indomethacin.

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.