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
Plain-language summary, compiled from the cited regulatory records
Mesalamine is an aminosalicylate medication [1]. It is approved for treating moderately active ulcerative colitis in adults [1]. The safety and effectiveness of mesalamine for use beyond six weeks have not been established [1].
In the past 12 months, there have been 3,969 adverse event reports associated with mesalamine [2]. Common adverse events reported include off-label use, ulcerative colitis, hematochezia (blood in stool), perceived drug ineffectiveness, and diarrhea [2].
Mesalamine is available under several brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
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 proctitis. Maintenance of remission of ulcerative proctitis.
How to take
CACanada· Health Canada
21 products
Uses
ZDS–Mesalamine Suppositories (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 mesalamine suppositories in children is limited.
Therefore, use should be limited to situations where a clear benefit is expected. ZDS– Mesalamine Suppositories 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: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. • treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.
Mesalamine delayed-release tablets are an aminosalicylate indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) • treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.
( 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) · PL366330011 · revised May 1, 2026
- [2]Health Canada (DPD) · 02562367 · revised March 18, 2026
- [3]FDA DailyMed · 14ac4435-903b-41… · revised September 15, 2025 [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.