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

Tolmetin is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis. Tolmetin is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

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

Tolmetin 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).

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

You should not use tolmetin 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 history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• fluid retention;
• liver or kidney disease; or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take tolmetin 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.

Tolmetin is not approved for use by anyone younger than 2 years old.

Use Tolectin (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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.

Stop using tolmetin and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• 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 side effects may include:

• indigestion, stomach pain, nausea, vomiting;
• diarrhea, gas;
• headache, dizziness;
• weakness; or
• changes in weight.

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.

Avoid drinking alcohol. It may 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 tolmetin (such as aspirin, ibuprofen, ketoprofen, or naproxen).