Salsalate Side Effects

Brand Names: Amigesic

Please note - some side effects for Salsalate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Salsalate - for the Consumer

Salsalate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Salsalate:

Heartburn; nausea; upset stomach.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Salsalate Side Effects - for the Professional

Salsalate

In two well-controlled clinical trials, the following reversible adverse experiences characteristic of salicylates were most commonly reported with Salsalate (n-280 pts; listed in descending order of frequency): tinnitus, nausea, hearing impairment, rash, and vertigo. These common symptoms of salicylates, i.e., tinnitus or reversible hearing impairment, are often used as a guide to therapy.

Although cause-and-effect relationships have not been established, spontaneous reports over a ten-year period have included the following additional medically significant adverse experiences: abdominal pain, abnormal hepatic function, anaphylactic shock, angioedema, bronchospasm, decreased creatinine clearance, diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and urticaria.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects including abdominal pain, diarrhea, nausea, and GI bleeding have been frequently reported.

Hepatic

Hepatic side effects including abnormal hepatic function and hepatitis have been reported.

Cardiovascular

Cardiovascular side effects including angioedema and hypotension have been reported.

Renal

Renal side effects including decreased creatinine clearance, nephritis, and urticaria have been reported.

Respiratory

Respiratory side effects including bronchospasm have been reported.

Other

Other side effects including tinnitus, hearing impairment, vertigo, rash, and anaphylactic shock have been reported.

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