Indocin SR is a nonsteroidal anti-inflammatory drug (NSAID).

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

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

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

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

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

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 Indocin SR. 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.

Indocin SR 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).

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

You should not use Indocin SR 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 Indocin SR 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.

Indocin SR 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.

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 Indocin SR (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 Indocin SR 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.

Indocin SR may cause serious side effects. Stop using Indocin SR 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 Indocin SR 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 Indocin SR 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 Indocin SR 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 Indocin SR, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.