Asacol (mesalamine) is a prescription medicine for ulcerative colitis, an inflammatory condition affecting the lining of the colon and rectum. Mesalamine belongs to the aminosalicylate class of anti-inflammatory medicines and acts primarily within the intestinal tract. Per FDA labeling, Asacol delayed-release tablets are indicated for mildly to moderately active ulcerative colitis in patients aged 5 and older, and for maintenance of remission in adults.
Asacol contains mesalamine (5-aminosalicylic acid, or 5-ASA) in a delayed-release formulation. The tablet coating delays release until the medicine reaches the intestinal tract, supporting localized activity in the colon. Different mesalamine products are not necessarily interchangeable. Formulation, strength, and dosing instructions should be verified for the specific product being dispensed or discussed.
A healthcare professional may prescribe Asacol for: Mildly to moderately active ulcerative colitis Achieving improvement during an active ulcerative-colitis episode Maintaining remission of mildly to moderately active ulcerative colitis in adults
Mesalamine is thought to work through a local anti-inflammatory effect in the intestinal tract. Its precise mechanism has not been fully established, but it affects inflammatory pathways involved in ulcerative colitis.
Per the FDA labeling for Asacol 400 mg delayed-release tablets: Active ulcerative colitis in adults: 800 mg (two 400 mg tablets) three times daily for 6 weeks. Maintenance of remission in adults: 1.6 g (four 400 mg tablets) daily, in two to four divided doses. Pediatric patients aged 5 and older: Dosing is weight-based and should follow the prescribing information and the healthcare professional's instructions.
Take exactly as prescribed May be taken with or without food Swallow tablets whole — do not cut, break, or chew them Maintain adequate fluid intake throughout treatment Safety Information Kidney function: Renal function should be assessed before starting treatment and monitored periodically during therapy. Patients with kidney impairment need specific medical consideration. Acute intolerance syndrome: Mesalamine can trigger a serious acute intolerance reaction that may resemble an ulcerative-colitis flare. Symptoms can include abdominal cramping, abdominal pain, bloody diarrhea, fever, headache, weakness, and rash. Contact a healthcare professional promptly if these develop. Hypersensitivity: Serious hypersensitivity reactions have been reported, sometimes involving the heart, kidneys, liver, lungs, or blood system. Liver disease: Patients with existing liver impairment should discuss the risks and benefits of treatment with a healthcare professional before starting. Kidney stones: Mesalamine has been associated with nephrolithiasis. Adequate fluid intake is recommended. Common Side Effects Adverse effects reported with mesalamine products may include: Abdominal discomfort or pain Headache Nausea Diarrhea Indigestion Rash Side-effect profile varies by formulation and patient. Serious kidney, liver, hypersensitivity, or intolerance reactions require medical evaluation.
Store as directed on the product packaging and prescribing information. Keep in the original container, away from heat and moisture, and out of reach of children.
Asacol is used to treat mildly to moderately active ulcerative colitis and, in adults, to help maintain remission.
Mesalamine, also known as 5-aminosalicylic acid (5-ASA).
Yes. Mesalamine belongs to the aminosalicylate class and works primarily within the intestinal tract.
The referenced FDA labeling covers 400 mg delayed-release tablets. Other mesalamine products, including Asacol HD, have different strengths and formulations. Verify the specific product before dispensing or publishing.
Yes. The FDA labeling states that Asacol delayed-release tablets may be taken with or without food.
No. Swallow them whole. Do not cut, break, or chew the tablets.
Yes. Mesalamine reduces inflammation associated with ulcerative colitis and helps maintain remission in eligible adult patients.
Yes. Renal function should be evaluated before treatment begins and checked periodically while taking Asacol.
Do not stop without speaking to your healthcare professional. Mesalamine may be prescribed to maintain remission even when symptoms are not active.
No. Different mesalamine products have different formulations, release characteristics, strengths, and dosing instructions. They should not be substituted for one another without clinical confirmation.