Sulfasalazine: Side Effects, Uses & Monitoring
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 b
- Data source
- FDA labeling via NIH DailyMed (label d596ac59…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
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-course1 juvenile 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 …
Conditions associated with Sulfasalazine in labeling
Frequently Asked Questions
What is Sulfasalazine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Sulfasalazine?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Sulfasalazine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Sulfasalazine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.