Balsalazide
Aminosalicylic Acid and Similar Agents
- Drug class
- Aminosalicylic Acid and Similar Agents
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 1
- Products on record
- 2
Overview
Balsalazide 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 |
|---|---|---|---|
| US United States | FDA | 2 | June 13, 2025 |
USUnited States· FDA
2 products
Uses
1 INDICATIONS AND USAGE Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
Limitations of Use:
Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide disodium capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
( 1 ) Limitations of Use: Safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. ( 1 )
Drug interactions
Known interactions involving Balsalazide. Select one for details. This list is informational and not a complete interaction checker.
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]FDA DailyMed · 029833fa-ec5c-6a… · revised February 18, 2025 [PDF]
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.