Mesalamine
Aminosalicylic Acid and Similar Agents
Sold as OCTASA · MEZERA · DASANTA · PENTASA · SALOFALK
- Drug class
- Aminosalicylic Acid and Similar Agents
- Availability
- Prescription only
- Routes
- Rectal, Oral
- Markets covered
- 3
- Products on record
- 177
- FDA reports (12 mo)
- 3,969
Overview
Mesalamine is an active pharmaceutical ingredient in the Aminosalicylic Acid and Similar Agents group (A07EC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 149 | May 29, 2026 |
| CA Canada | Health Canada | 21 | May 13, 2026 |
| US United States | FDA | 7 | September 15, 2025 |
GBUnited Kingdom· MHRA
149 products
Uses
Treatment of acute mild to moderate ulcerative colitis that is limited to the rectum (ulcerative proctitis).
How to take
CACanada· Health Canada
21 products
Uses
SALOFALK® (mesalamine suppositories) is indicated for: • management of ulcerative proctitis. • as adjunctive therapy in more extensive distal ulcerative colitis (DUC). 1 Pediatrics Information on the safety and efficacy of SALOFALK in children is limited.
Therefore, use should be limited to situations where a clear benefit is expected. SALOFALK should not be used in infants under two years of age. 2 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
How to take
USUnited States· FDA
7 products
Uses
1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.
Limitations of Use :
Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. Mesalamine delayed-release tablets are an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults.
(1) Limitation of Use : Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established (1)
How to take
Drug interactions
Known interactions involving Mesalamine. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 272. 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) · PL086370018 · revised April 10, 2026
- [2]Health Canada (DPD) · 02112760 · revised March 22, 2025
- [3]FDA DailyMed · 00f77203-3615-47… · revised May 23, 2024 [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.