Mesalamine: Side Effects, Uses & Monitoring
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
- Data source
- FDA labeling via NIH DailyMed (label 83864c82…)
- 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* |
|---|---|
| Headache | 36% |
| Abdominal pain | 18% |
| Eructation | 16% |
| Nausea | 15% |
| Asthenia | 15% |
| Pain | 14% |
| Pharyngitis | 11% |
| Diarrhea | 9% |
| Dizziness | 8% |
| Fever | 8% |
| Back pain | 7% |
| Flatulence | 7% |
| Rash | 6% |
| Dyspepsia | 6% |
| Rhinitis | 5% |
| Arthralgia | 5% |
| Hypertonia | 5% |
| Vomiting | 5% |
| Constipation | 5% |
| Dysmenorrhea | 3% |
*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)
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Conditions associated with Mesalamine in labeling
Frequently Asked Questions
What is Mesalamine 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 Mesalamine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Mesalamine. Individual risk varies.
Does Mesalamine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Mesalamine.
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.