Salsalate

Warning

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 infrequently 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.

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 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 immediately 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.

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.

Tell your doctor immediately 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 immediately 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 immediately: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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