Nonsteroidal anti-inflammatory drugs (including salsalate) may rarely increase the risk for a heart attack or stroke. This effect does not apply to low-dose aspirin. (See Drug Interactions section.) The risk may be greater in people with heart disease or increased risk for heart disease (e.g., due to high blood pressure, diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This bleeding can occur without warning symptoms at any time during treatment.
Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: chest pain, severe dizziness, weakness on one side of the body, sudden vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)
Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.Who should not take Mono-Gesic?
Salsalate is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).
Take this medication by mouth, usually 2 to 3 times daily with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.
Dosage is based on your medical condition and response to therapy. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. For ongoing conditions such as arthritis, continue taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist.
For certain conditions (e.g., arthritis), it may take up to 2 weeks of taking this drug regularly until you get the full benefit.
If you are taking this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medicine may not work as well.
Inform your doctor if your symptoms persist or worsen or if you develop new symptoms.
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, swelling of ankles/feet/hands, sudden/unexplained weight gain, hearing changes (e.g., ringing in the ears, decreased hearing).
Stop taking salsalate and tell your doctor right away if any of these rare but very serious side effects occur: fast/pounding heartbeat, 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.
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 any unusual 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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
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.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: 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), cyclosporine, 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.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room 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.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., blood pressure, complete blood count, liver/kidney function tests, salicylic acid levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you have arthritis, lifestyle changes (e.g., weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.
If you are taking this drug on a regular schedule (not "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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