FDA label
What is sulfasalazine used for?
The FDA-approved uses of sulfasalazine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Sulfasalazine tablets are indicated:a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted sulfasalazine?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Sulfasalazine, tablet
Indications and Usage, quoted from the label by Rising Pharma Holdings, Inc. (ANDA219046). Cross-references to other label sections are left out.
Sulfasalazine tablets are indicated:a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.
Source: DailyMed label, set id 3254432e-87a4-4af0-afd1-d9e6f1b0efd4, version 1, effective November 6, 2025. NDC 16571-261, one of 5 listings for this product.
Sulfasalazine, tablet, delayed release
Indications and Usage, quoted from the label by Sunrise Pharmaceutical, Inc. (ANDA075339). Cross-references to other label sections are left out.
SULFASALAZINE DELAYED RELEASE Tablets, USP are indicated:
a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;b)for the prolongation of the remission period between acute attacks of ulcerative colitis;c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); andd)in the treatment of pediatric patients with polyarticular-course1juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.
SULFASALAZINE DELAYED RELEASE Tablets, USP are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.
In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, SULFASALAZINE DELAYED RELEASE Tablets, USP do not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of SULFASALAZINE DELAYED RELEASE Tablets, USP is apparent.
Source: DailyMed label, set id d596ac59-b643-4181-80ba-f2db1cc3459c, version 4, effective December 11, 2025. NDC 11534-201, one of 1 listing for this product.
Questions
What is sulfasalazine used for?
The FDA label says: “Sulfasalazine tablets are indicated:a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; andb) for the prolongation of the remission period between acute attacks of ulcerative colitis.”
What drug class is sulfasalazine?
FDA lists sulfasalazine in the Aminosalicylate established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.