SIDE EFFECTS: Upset stomach, dizziness, or nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if any of these unlikely but serious side effects occur: stomach pain, heartburn, hearing changes (e.g., ringing in the ears, decreased hearing), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Stop taking salsalate and tell your doctor right away if any of these rare but very serious side effects occur: fast/pounding heartbeat, signs of kidney problems (such as change in the amount of urine), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat). This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking salsalate and consult your doctor or pharmacist right away: dark urine, yellowing eyes/skin, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking salsalate, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or to salicylic acid; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), heart disease (e.g., history of heart attack), high blood pressure, stroke, swelling of the ankles/feet/hands, blood disorders (e.g., anemia), bleeding/clotting problems, asthma, growths in the nose (nasal polyps), certain genetic conditions (G-6-PD deficiency, pyruvate kinase deficiency). Kidney problems can sometimes occur with the use of NSAID medications, including salsalate. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. Before having surgery, tell your doctor or dentist that you are using this medication. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney problems. This medication is similar to aspirin. Children and teenagers should not take this medication if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness. This medication is not recommended for use during pregnancy. Consult your doctor before using this medication if you are or think you may be pregnant. Tell your doctor right away if you become pregnant while taking this medication. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug long-term and in high doses. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), certain drugs for seizures (phenytoin, valproic acid), cidofovir, corticosteroids (e.g., prednisone), drugs for gout (e.g., probenecid, sulfinpyrazone), drugs that affect the acidity of urine (e.g., ammonium chloride, acetazolamide), lithium, methotrexate, pemetrexed, tenofovir. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, ketorolac, or naproxen) that are similar to this drug and, if taken together, may increase your risk for side effects. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details. This medication may interfere with certain laboratory tests (including certain urine glucose tests, thyroid hormone levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: ringing in the ears, confusion, vomiting, diarrhea, dizziness, fast breathing, seizures.