People who take nonsteroidal anti-inflammatory medications (NSAIDs) (other than aspirin) such as salsalate may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, heart failure, a heart attack, or a stroke; if you smoke; and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take salsalate right before or right after the surgery.

NSAIDs such as salsalate may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, smoke, or drink large amounts of alcohol while taking salsalate. Tell your doctor if you take any of the following medications: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); aspirin; other NSAIDS such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking salsalate and call your doctor: stomach pain, heartburn, vomiting a substance that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body’s response to salsalate. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with salsalate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Salsalate is used to relieve pain, tenderness, swelling, and stiffness caused by rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and other conditions that cause swelling. Salsalate is in a class of nonsteroidal anti-inflammatory medications (NSAIDs) called salicylates. It works by stopping the body’s production of a substance that causes pain, fever, and swelling.

Salsalate comes as a tablet to take by mouth. It is usually taken two to three times a day. Salsalate may be taken with food or milk to prevent stomach upset. Take salsalate 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 salsalate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

It may take three to four days until you feel the full benefit of the medication. If your symptoms do not improve or get worse, call your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking salsalate,

• Tell your doctor and pharmacist if you are allergic to salsalate, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the ingredients in salsalate tablets. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); antacids; diuretics (”water pills”) such as furosemide (Lasix); lithium (Eskalith, Lithobid);medications for gout such as probenecid (Probalan) and sulfinpyrazone (Anturane); methazolamide; certain oral medications for diabetes such as chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl), glipizide (Glucotrol, in Metaglip),glyburide (Diabeta, Glynase, Micronase), tolazamide (Tolinase), and tolbutamide;certain medications for seizures such as phenytoin (Dilantin, Phenytek) and valproic acid (Depakene, Depakote); methotrexate (Trexall); penicillin (Veetids); salicylates such as bismuth subsalicylate (Kaopectate, Pepto-Bismol), choline magnesium trisalicylatecholine salicylate (Arthropan), diflunisal (Dolobid), and magnesium salicylate (Doan’s, others); and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had any of the conditions in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); gout; kidney or liver disease; or swelling of the hands, feet, ankles or lower legs.
• You should know that salsalate should not be taken by children and teenagers who have chicken pox, flu, flu symptoms, or who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye’s Syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).
• Tell your doctor if you are pregnant, especially if you are in the last few months of pregnancy; plan to become pregnant; or are breast-feeding. If you become pregnant while taking salsalate, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking salsalate.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Salsalate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Diarrhea
• Dizziness

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• Ringing in the ears
• Loss of hearing
• Difficulty breathing or swallowing
• Shortness of breath
• Hoarseness
• Fast heartbeat
• Unexplained weight gain
• Swelling of the eyes, face, tongue, lips, throat, arms, hands, feet, ankles, or lower legs
• Rash
• Hives
• Blisters
• Itching
• Unusual bleeding or bruising
• Pale or cold skin
• Fever
• Nausea
• Headache
• Extreme tiredness
• Weakness
• Lack of energy
• Loss of appetite
• Pain in the upper right part of the stomach
• Yellowing of the skin or eyes
• Flu-like symptoms
• Cloudy, discolored, or bloody urine
• Back pain
• Difficult or painful urination

Salsalate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• Ringing in the ears
• Dizziness
• Headache
• Confusion
• Extreme tiredness
• Sweating
• Rapid breathing
• Extreme thirst
• Muscle cramps
• Fainting
• Flushing
• Loss of consciousness

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.