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This document provides crucial safety and warning information for individuals considering or currently using salsalate, a nonsteroidal anti-inflammatory drug (NSAID). It is essential to understand the potential risks, precautions, and necessary actions related to this medication. Please review the information below and consult your healthcare provider for further guidance.

• Heart Attack and Stroke Risk: Salsalate may increase the risk of blood clots, heart attacks, or strokes, particularly when taken in high doses or over an extended period. Those with existing heart conditions or risk factors such as smoking, high blood pressure, or diabetes should exercise caution. Avoid using salsalate before or after heart bypass surgery. Seek immediate medical assistance if you experience chest pain, breathing difficulties, weakness on one side, or speech impairment.

• Stomach Bleeding and Ulcers: The drug may cause severe stomach bleeding or ulcers, sometimes without warning signs. Individuals with a history of ulcers, older adults, or those using certain medications (e.g., aspirin, corticosteroids) should be particularly cautious. Symptoms like persistent stomach pain, black stools, or vomit resembling coffee grounds require urgent medical attention.

• High Blood Pressure and Heart Failure: Salsalate can cause fluid retention, leading to increased blood pressure or heart failure risk. Inform your healthcare provider of any heart conditions or if you are on blood pressure medication before starting salsalate. Report any instances of fainting, chest pain during physical activity, or irregular heartbeat promptly.

• Kidney Damage and Elevated Potassium Levels: The medication may impair kidney function, especially if combined with other drugs affecting the kidneys or in individuals with kidney, liver, or heart issues. Monitor changes in urination frequency and consult your provider if concerns arise.

• Liver Damage: Though rare, salsalate can cause severe liver damage. The risk increases with concurrent use of other liver-damaging drugs like acetaminophen. Regular liver function tests may be necessary for long-term users. Symptoms such as fever, fatigue, jaundice, or dark urine require immediate medical evaluation.

• Severe Allergic and Skin Reactions: Allergic reactions, including life-threatening ones, may occur. Notify your provider about any known allergies to aspirin or other NSAIDs. Seek emergency help if you develop hives, skin rash, facial swelling, or breathing difficulties.

• Pregnancy and Breastfeeding: Salsalate is not recommended for pregnant or breastfeeding women due to potential harm to the unborn child or delivery complications during the latter half of pregnancy.

• Contraindications: Avoid using salsalate if you have a history of asthma or allergic reactions to aspirin or other NSAIDs, or if you have had coronary artery bypass graft surgery.

Always discuss the risks and benefits of using salsalate with your healthcare provider, especially if you have underlying health conditions or are taking other medications.

Common side effects:

• upset stomach
• dizziness
• nausea
• ringing in the ears
• temporary hearing problems
• rash

Less common but important to monitor:

• stomach pain
• diarrhea
• stomach bleeding
• heartburn
• hives

Serious side effects:

• faintness
• vomiting blood
• dark stools
• chest pain
• tightness extending to shoulder, arm, neck, or jaw
• difficulty breathing
• weakness in one part of the body
• slurred speech
• breathing difficulties
• swelling
• fast heartbeat
• swelling of the stomach
• yellowing skin or eyes
• confusion
• dark urine
• tiredness
• dry and itchy skin
• reduced appetite
• decreased urination
• muscle cramps
• hives
• blisters
• swelling of lips or tongue
• breathing difficulties
• skin reddening
• rash
• fever

Interactions with high risk of serious adverse effects and should be avoided:

• Anti-platelet drugs such as clopidogrel
• Anticoagulants such as dabigatran, enoxaparin, warfarin
• NSAIDs such as aspirin, ibuprofen, ketorolac, naproxen

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Aliskiren
• ACE inhibitors such as captopril, lisinopril
• Angiotensin II receptor blockers such as losartan, valsartan
• Seizure medications such as phenytoin, valproic acid
• Cidofovir
• Corticosteroids such as prednisone
• Dichlorphenamide
• Gout medications such as probenecid
• Drugs that change urine acidity such as ammonium chloride, acetazolamide
• Lithium
• Methotrexate
• Pemetrexed
• Tenofovir