Sulfasalazine
Aminosalicylic Acid and Similar Agents
- Drug class
- Aminosalicylic Acid and Similar Agents
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 24
- FDA reports (12 mo)
- 3,381
Overview
Plain-language summary, compiled from the cited regulatory records
Sulfasalazine is a medication classified as an aminosalicylic acid and similar agent [1]. It is approved for use in treating ulcerative colitis. Specifically, sulfasalazine is indicated for the treatment of mild to moderate ulcerative colitis and can be used as an add-on therapy for severe cases [1]. Additionally, it is used to help maintain remission periods between flare-ups of ulcerative colitis [1].
In the market, sulfasalazine is available under various brand names [1]. Recent adverse event reports indicate a count of 3381 within a 12-month period [2]. The most frequently reported events include off-label use, perceptions of the drug being ineffective, rheumatoid arthritis, rash, and pain [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 18 | May 15, 2026 |
| CA Canada | Health Canada | 5 | December 16, 2025 |
| US United States | FDA | 1 | December 12, 2022 |
GBUnited Kingdom· MHRA
18 products
Uses
Induction and maintenance of remission of ulcerative colitis and treatment of active Crohn's disease.
How to take
CACanada· Health Canada
5 products
How to take
C. should be adjusted according to the response to the treatment and the patient's tolerance to the drug. The tablets / delayed-release tablets should be taken at regular and even intervals over the 24-hour period. C. tablets should preferably be taken with a meal.
For intestinal inflammatory diseases, the night-time doses interval should not exceed 8 hours. Patients not previously treated with sulfasalazine should increase the dose gradually during the first few weeks. The incidence of adverse reactions tends to increase with daily dosages of 4 g or more; patients receiving these doses should be advised of this possibility and should be carefully observed for the appearance of adverse reactions.
Recommended Dose and Dosage Adjustment Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease 1.
Acute attacks:
Adults: Severe attacks: 2–4 tablets, 3–4 times daily Moderate and mild attacks: 2 tablets, 3–4 times daily. Children: 25–35 kg body weight: 1 tablet, 3 times daily 35–50 kg body weight: 2 tablets, 2-3 times daily 2.
USUnited States· FDA
1 product
Uses
INDICATIONS AND USAGE
Sulfasalazine Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.
How to take
Drug interactions
Known interactions involving Sulfasalazine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 362. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL004270196 · revised October 18, 2024
- [2]Health Canada (DPD) · 00598461 · revised March 22, 2025
- [3]FDA DailyMed · 029716bd-ee1a-48… · revised December 12, 2022 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.