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]
