Olsalazine: Side Effects, Uses & Monitoring
INDICATIONS AND USAGE: Olsalazine is indicated for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.
- Data source
- FDA labeling via NIH DailyMed (label 9dd522a3…)
- 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.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Diarrhea | 11.1% |
| Abdominal pain/cramps | 10.1% |
| Dyspepsia | 4.3% |
| Arthralgia/joint pain | 4% |
| Increased blood in stool | 3.4% |
| Nausea | 3% |
| Headache | 3% |
| Fatigue/drowsiness/lethargy | 2.9% |
| Insomnia | 2.4% |
| Rash | 2.3% |
| Heartburn | 2% |
| Bloating | 1.5% |
| Upper respiratory infection | 1.5% |
| Itching | 1.3% |
| Rectal bleeding | 1% |
| Insomina | 1% |
| Dizziness | 1% |
| Anorexia | 1% |
| Light headedness | 1% |
| Depression | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
INDICATIONS AND USAGE: Olsalazine is indicated for the maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine.
Conditions associated with Olsalazine in labeling
Frequently Asked Questions
What is Olsalazine 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 Olsalazine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Olsalazine. Individual risk varies.
Does Olsalazine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Olsalazine.
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.