Salsalate is a non-steroidal anti-inflammatory drug (NSAID) in a group of drugs called salicylates (sa-LIS-il-ates).

Salsalate is used to reduce pain, swelling, and joint stiffness caused by rheumatoid arthritis, osteoarthritis, or rheumatic disorder.

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

Salsalate 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).

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

You should not use salsalate if you are allergic to it, or if you have:

• severe kidney disease; or
• a history of severe allergic reaction after taking aspirin, an NSAID, or other salicylates.

Do not take this medicine if you have a fever, flu symptoms, or chickenpox. Salicylates can cause Reye's syndrome, a serious and sometimes fatal condition, if you have any of these conditions.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, congestive heart failure;
• a stroke or heart attack;
• swelling or fluid retention;
• a stomach ulcer;
• bleeding in your stomach or intestines;
• liver or kidney disease;
• asthma; or
• a bleeding or blood clotting disorder.

If you are pregnant, you should not take salsalate 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.

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

Older adults may be more sensitive to the effects of this medicine.

Use Mono-Gesic (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, 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).

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

• swelling in your hands or feet, rapid weight gain;
• severe headache, blurred vision, pounding in your neck or ears;
• pale skin, unusual tiredness, cold hands and feet;
• liver problems--nausea, stomach pain (upper right side), tiredness, itching, 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;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems.

Older adults may be more likely to have side effects from salsalate.

Common side effects may include:

• nausea;
• hearing problems;
• a spinning sensation;
• rash; or
• abnormal liver function tests.

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

Ask a doctor or pharmacist before taking other medicines that may contain a salicylate (such as aspirin, magnesium salicylate, choline salicylate, diflunisal, Ecotrin, Tricosal, Trilisate, and others).

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to salsalate (such as aspirin, choline salicylate, or magnesium salicylate).

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

If you are also taking low-dose aspirin to prevent heart attack or stroke, do not stop taking it or change your dose without your doctor's advice. Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Avoid smoking, since it can also increase your risk of stomach bleeding.