Asacol

Asacol is a prescription medication used to treat ulcerative colitis, or inflammation of the lining of the colon. It helps relieve the symptoms of ulcerative colitis including diarrhea, rectal bleeding, and stomach pain. Asacol belongs to a group of drugs called aminosalicylates. These work by stopping the body from producing a certain substance that may cause pain or inflammation in the colon.

Asacol comes in delayed-release tablets and are usually taken 3 times a day, with or without food. 

Asacol also comes in a high dose delayed-release tablet (Asacol HD). It is taken 3 times a day, with or without food.

Swallow tablets whole (do not chew, crush, or split).

​Common side effects of Asacol include stomach pain and constipation. Asacol can also cause dizziness. Do not drive until you know how it affects you. 

Asacol is a prescription medication used to treat ulcerative colitis (UC). UC is a condition in which part or all of the lining of the colon (also known as the large intestine) is swollen or worn away. It is used to keep it from coming back ("maintain remission").

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Warner Chilcott (US), LLC

Serious side effects have been reported with Asacol. See “Asacol Precautions” section.

Common side effects of Asacol include:

• headache
• nausea
• sneezing
• runny nose
• flatulence
• stomach pain
• constipation
• diarrhea
• dizziness
• back pain
• rash
• cough

This is not a complete list of Asacol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines that can damage the kidneys, including non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• azathioprine (Imuran)
• 6-mercaptopurine (Purinethol)
• antacids such as Maalox, Mylanta, Mag-Ox, Caltrate, Tums, or Rolaids

This is not a complete list of Asacol drug interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Asacol including:

• Kidney problems. Tell your doctor if you take non-steroidal anti-inflammatory drugs or have kidney disease. Your doctor will check your kidney function with a simple blood test before you start taking Asacol.
• Mesalamine may worsen ulcerative colitis. Tell your doctor if you experience the following symptoms:
  • cramping
  • acute abdominal pain
  • bloody diarrhea
  • fever
  • headache
  • rash
• Hypersensitivity reaction. An allergic reaction is possible with Asacol. Tell your doctor if you are allergic to sulfasalazine (Azulfidine) or Asacol. Serious reactions can lead to heart problems, like myocarditis or pericarditis.
• Liver failure is possible with Asacol. Tell your doctor if you have liver disease.
• Upper GI tract obstruction. Pyloric stenosis or an obstruction in the digestive tract could prevent Asacol from reaching the colon and treating ulcerative colitis.
• Pericarditis (inflammation of the lining around the heart). Tell your doctor if you experience symptoms of pericarditis including chest pain, rapid heartbeat, difficulty breathing, and fever. Your doctor may want to temporarily stop use of Asacol.

Intact, partially intact, and/or capsule shells have been reported in the stool. Contact your doctor if this occurs repeatedly.

Do not take Asacol if you:

• have kidney disease
• are allergic to mesalamine or any ingredients in Asacol
• are allergic to salicylates (including aspirin)

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Asacol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Asacol, tell your doctor about all your medical conditions. Especially tell your doctor if you:

• have had an allergic reaction to sulfasalazine (Azulfidine), salicylates (such as aspirin), or Asacol
• are taking nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil) and aspirin (Ecotrin) or other drugs that affect the kidneys
• are taking azathioprine (Imuran) or 6-mercaptopurine (Purinethol)
• have cramping, abdominal pain, bloody diarrhea, fevers, headaches, or rashes
• have a history of myocarditis or pericarditis
• have had inflamed pancreas (pancreatitis)
• are allergic to other things, such as foods, preservatives, or dyes
• have kidney, liver, or heart disease
• have a history of stomach blockage
• repeatedly see intact, partially intact, and/or capsule shells in the stool
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescriptions medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.  

The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Asacol: Limited published data on Asacol use in pregnant women are insufficient to inform a drug-associated risk. 

Asacol HD:

Asacol HD falls into category C. There are no well-controlled studies in pregnant women. Asacol HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in Asacol is excreted in human breast milk. The effect of Asacol on the nursing infant is not known.

Take Asacol exactly as prescribed. Do not change the dose or stop taking Asacol without talking to your doctor.

Asacol comes in delayed-release tablets and are usually taken 3 times a day, with or without food.

Asacol also comes in a high dose delayed-release tablet (Asacol HD). It is taken 3 times a day, with or without food.

Swallow tablets whole (do not chew, crush, or split).

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• Asacol (mesalamine delayed release tablets)
  • For the treatment of mildly to moderately active ulcerative colitis, the usual dosage in adults is two 400 mg tablets to be taken 3 times a day for a total daily dose of 2.4 grams.
• Asacol HD (mesalamine delayed release tablets)
  • The recommended dosage is two 800 mg tablets three times daily (4.8 grams/day) with or without food.
  • NOTE: one Asacol HD 800 mg tablet cannot be substituted for two Asacol delayed-release 400 mg tablets. 

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Asacol at room temperature.
• Keep this and all medicines out of the reach of children.