Salsalate

Mechanism-of-action class: Cyclooxygenase Inhibitors.

• Carefully consider the potential benefits and risks of Salsalate tablets and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).

• Salsalate tablets are contraindicated in patients with known hypersensitivity to salsalate. Salsalate tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.contraindicated

Carefully consider the potential benefits and risks of Salsalate tablets and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with Salsalate tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder. Adults: The usual dosage is 3000 mg daily, given in divided doses as follows: 1) two doses of two 750 mg tablets; 2) two doses of three 500 mg tablets; or 3) three doses of two 500 mg tablets. Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory. Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady-state. There is no evidence for development of tissue tolerance (tachyphylaxis), but salicylate therapy may induce increased activity of metabolizing liver enzymes, causing a greater rate of salicyluric acid production and excretion, with a resultant increase in dosage requirement for maintenance of therapeutic serum salicylate levels. Children: Dosage recommendations and indications for salsalate use in children have not been established.

Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Salsalate contains a salicylate and therefore is not recommended for use in patients with chicken pox, influenza, or flu symptoms. CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS ).

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. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Death has followed ingestion of 10 to 30 g of salicylates in adults, but much larger amounts have been ingested without fatal outcome. Symptoms: The usual symptoms of salicylism - tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea - will occur. More severe intoxication will lead to disruption of electrolyte balance and blood pH, and hyperthermia and dehydration. Treatment: Further absorption of salsalate from the G.I. tract should be prevented by emesis (syrup of ipecac), and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate I.V. therapy. Adequate renal function should be maintained. Hemodialysis or peritoneal dialysis may be required in extreme cases.

1. 1Dizziness576.1%
2. 2Drug Ineffective525.6%
3. 3Arthralgia515.5%
4. 4Pain495.2%
5. 5Dyspnoea485.1%
6. 6Nausea424.5%
7. 7Fall414.4%
8. 8Drug Hypersensitivity384.1%
9. 9Fatigue384.1%
10. 10Asthenia363.9%
11. 11Pain In Extremity363.9%
12. 12Diarrhoea353.7%
13. 13Back Pain343.6%
14. 14Headache343.6%
15. 15Chronic Kidney Disease323.4%

The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Salsalate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control
  Withdrawn · Phase 1 · Interventional · 0 enrolled · McMaster University
  NCT03816488updated 2026-06-12
• Omega-3 Fatty Acid Lipidomics in Diabetes Peripheral Neuropathy
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 100 enrolled · University of Iowa
  NCT05169060updated 2026-04-06
• Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
  Recruiting · Early phase 1 · Interventional · 24 enrolled · University of Iowa
  NCT06489249updated 2025-12-15
• Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction
  Completed · Phase 2 · Interventional · 60 enrolled · University of Illinois at Chicago
  NCT03229408updated 2025-06-10
• Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
  Completed · Early phase 1 · Interventional · 24 enrolled · University of Iowa
  NCT03482440updated 2025-06-03
• Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy
  Completed · Phase 2 · Phase 3 · Interventional · 61 enrolled · University of Michigan
  NCT02936843updated 2025-05-16
• Salsalate in Patients Mild to Moderate Alzheimer's Disease
  Completed · Phase 1 · Interventional · 40 enrolled · Adam Boxer
  NCT03277573updated 2025-04-16
• Endometriosis and Microvascular Dysfunction: Role of Inflammation
  Recruiting · Early phase 1 · Interventional · 24 enrolled · Penn State University
  NCT05069740updated 2024-11-05
• Inflammation Inhibition in Prediabetic Humans
  Terminated · Phase 2 · Interventional · 21 enrolled · Gary L. Pierce
  NCT01977417updated 2023-09-11
• Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease
  Completed · Phase 2 · Interventional · 5 enrolled · Rutgers, The State University of New Jersey
  NCT04146038updated 2023-05-24

Frequently asked questions

How does Salsalate work?

Mechanism-of-action class: Cyclooxygenase Inhibitors.

What is Salsalate used for?

According to FDA labeling, Salsalate carries indications including: Carefully consider the potential benefits and risks of Salsalate tablets and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Salsalate?

Salsalate is classified as Salicylic acid and derivatives, Cyclooxygenase Inhibitors, Decreased Prostaglandin Production.

What are the brand names for Salsalate?

Salsalate is marketed under brand names including Disalcid.

What are the contraindications for Salsalate?

Salsalate labeling lists contraindications including: Salsalate tablets are contraindicated in patients with known hypersensitivity to salsalate. Salsalate tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.. Always consult the full prescribing information and a clinician.