Balsalazide: Side Effects, Uses & Monitoring
Balsalazide disodium tablets is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.
- Data source
- FDA labeling via NIH DailyMed (label 53d2f754…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
No structured frequency data available in current labeling. Consult the official label.
Labeled uses (from FDA prescribing information)
Balsalazide disodium tablets is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Limitations of Use: Effectiveness of balsalazide disodium tablets in the treatment of female patients was not demonstrated in clinical trials [seeClinical Trials (14) ]. Safety and effectiveness of balsalazide disodium tablets therapy beyond 8 weeks have not been established.
Conditions associated with Balsalazide in labeling
Frequently Asked Questions
What is Balsalazide used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Balsalazide?
Current labeling for this ingredient does not include a structured frequency table that we can reproduce. Review the official label linked below.
Does Balsalazide require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Balsalazide.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.