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
Plain-language summary, compiled from the cited regulatory records
Balsalazide is a medication classified as an aminosalicylic acid and similar agent [1]. It is approved for treating mildly to moderately active ulcerative colitis in patients aged 5 years and older [1].
The safety and effectiveness of balsalazide disodium capsules have been studied for specific durations. For pediatric patients aged 5 to 17 years, efficacy has not been established beyond 8 weeks of treatment. Similarly, for adult patients, safety and effectiveness have not been established beyond 12 weeks [1].
This medication is available under various brand names [1]. In the past 12 months, there have been no adverse event reports for this active ingredient [2].
This is not medical advice. Consult a qualified healthcare professional.
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.