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Salsalate Side Effects

For the Consumer

Applies to salsalate: oral tablets

Warning

    Cardiovascular Risk
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).b Risk may increase with duration of use.b Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.b (See Cardiovascular Effects under Cautions.)

  • Contraindicated for the treatment of pain in the setting of CABG surgery.b

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).b Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.b Geriatric individuals are at greater risk for serious GI events.b (See GI Effects under Cautions.)

Side effects include:

Tinnitus, nausea, hearing impairment, rash, vertigo.

For Healthcare Professionals

Applies to salsalate: oral capsule, oral tablet

General

The most frequently reported side effects were usually reversible and included tinnitus, nausea, hearing impairment, rash, and vertigo.[Ref]

Gastrointestinal

Frequency not reported: Nausea, abdominal pain, diarrhea, gastrointestinal bleeding[Ref]

Cardiovascular

Frequency not reported: Hypotension[Ref]

Dermatologic

Frequency not reported: Rash, angioedema, urticaria[Ref]

Hepatic

Frequency not reported: Hepatic function abnormal, hepatitis[Ref]

Renal

Frequency not reported: Nephritis[Ref]

Respiratory

Frequency not reported: Bronchospasm[Ref]

Other

Frequency not reported: Tinnitus, hearing impaired, vertigo, creatinine clearance decreased[Ref]

Immunologic

Frequency not reported: Anaphylactic shock[Ref]

References

1. "Product Information. Salsalate (salsalate)." Amneal Pharmaceuticals, Glasgow, KY.

2. "Product Information. Disalcid (salsalate)." 3M Pharmaceuticals, St. Paul, MN.

3. Phillips BB, Joss JD, Mulhausen PL "Blood pressure elevation in a patient treated with salsalate." Ann Pharmacother 36 (2002): 624-7

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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