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.

You should not use salsalate if you have severe kidney disease, or if you have ever had a severe allergic reaction after taking aspirin, an NSAID (nonsteroidal anti-inflammatory drug), or other salicylates.

Salsalate can increase your risk of fatal heart attack or stroke. 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.

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

It may take up to 4 days before you receive the full benefit of taking salsalate. Your doctor will determine how long to treat you with salsalate.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using salsalate.

If you need surgery, dental work, or a medical procedure, tell your healthcare professional you currently use this medicine. You may need to stop for a short time.

If you use this medicine 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.

Usual Adult Dose for Osteoarthritis:

3000 mg orally per day in 2 or 3 divided doses

Comments:
-Lower doses may be necessary to achieve therapeutic blood concentration and to avoid more common side effects (e.g., auditory effects).
-Alleviation of symptoms is gradual and full benefit may not be achieved for 3 to 4 days.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and related rheumatic disorder

Usual Adult Dose for Rheumatoid Arthritis:

3000 mg orally per day in 2 or 3 divided doses

Comments:
-Lower doses may be necessary to achieve therapeutic blood concentration and to avoid more common side effects (e.g., auditory effects).
-Alleviation of symptoms is gradual and full benefit may not be achieved for 3 to 4 days.

Uses: For the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and related rheumatic disorder

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.

Since salsalate is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

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

Overdose symptoms may include ringing in your ears, headache, confusion, severe dizziness or drowsiness, sweating, fast breathing, severe vomiting or diarrhea.

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.

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 salsalate 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.

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).

Salsalate may cause serious side effects. 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 of salsalate 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.

Tell your doctor about all your current medicines. Many drugs can affect salsalate, especially:

• lithium;

• methotrexate;

• naproxen;

• phenytoin;

• penicillin;

• a diuretic or "water pill";

• oral diabetes medicine;

• heart or blood pressure medication--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril;

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

• steroid medicine--prednisone, dexamethasone, methylprednisolone, and others.

This list is not complete and many other drugs may affect salsalate. This includes 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 salsalate.

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.