A treatment for moderately active ulcerative colitis

If you have been diagnosed with moderately active ulcerative colitis (UC), it is likely your doctor will recommend a medicine called mesalamine, also known as 5-ASA. This is a common treatment for UC.

  • ASACOL® HD (mesalamine) has been shown to reduce the symptoms associated with moderately active UC, including rectal bleeding and the frequency of bowel movements in adults

How ASACOL HD works

  • ASACOL HD is a delayed-release tablet
  • The way ASACOL HD works is not known, but it is thought to deliver medicine to the colon to help treat symptoms of moderately active UC

How to take ASACOL HD

It’s important to take ASACOL HD as prescribed. Always follow your
doctor’s instructions.

  • The recommended dosage for moderately active UC
    is 2 ASACOL HD 800 mg tablets 3 times a day for a total of
    4.8 g/d (6 tablets) for a duration of 6 weeks
  • It’s very important to take your tablets as prescribed
  • Be sure to swallow the ASACOL HD tablets whole. Do not
    break, cut, or chew the tablets, because the coating is an
    important part of the delayed-release formula
  • Drink an adequate amount of fluids
  • Protect your ASACOL HD tablets from moisture. Close the
    container tightly after each use
  • One ASACOL HD 800 mg tablet cannot be substituted for
    2 mesalamine delayed-release 400 mg tablets

What is ASACOL HD?

ASACOL HD (mesalamine) delayed-release tablets is a prescription medication used to treat moderately active ulcerative colitis (UC) in adults. Safety and effectiveness of ASACOL HD beyond 6 weeks has not been established.

IMPORTANT RISK INFORMATION

Do not take ASACOL HD if you are:

  • allergic to salicylates, or aminosalicylates such as aspirin or medications that contain aspirin
  • allergic to any of the ingredients of ASACOL HD

Before taking ASACOL HD tell your doctor if you:

  • have or have had kidney problems
  • are allergic to sulfasalazine
  • have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)
  • take any iron-containing supplements
  • have or have had liver problems
  • are pregnant, nursing, or are planning to become pregnant or to breastfeed
  • have any other medical conditions

Tell your doctor about all medications you are taking, including prescription and over-the-counter medicinces, vitamins, and herbal supplements. Taking ASACOL HD with nonsteroidal anti-inflammatory drugs (NSAIDs), may cause kidney problems Taking ASACOL HD with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

What are the possible side effects of ASACOL HD?

ASACOL HD may cause serious side effects, including:

  • Kidney problems: Your doctor may check to see how your kidneys are working before taking ASACOL HD.
  • Acute Intolerance Syndrome and Other Allergic Reactions: Some people who use ASACOL HD can have allergic-type reactions, including acute intolerance syndrome. Other allergic reactions can cause heart problems including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body including the kidneys, liver and lungs. When this happens, it is usually in people who have had an allergic reaction to sulfasalazine. Stop using ASACOL HD and contact your doctor right away if you get any of these symptoms: cramping, stomach (abdominal) pain, bloody diarrhea, fever, headache, chest pain, decrease in the amount of urine, shortness of breath, eye inflammation, fatigue, and rash.
  • Liver Failure: This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your doctor right away if you get any of these symptoms while using ASACOL HD: yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting.
  • Sun Sensitivity: ASACOL HD can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. Try to limit your time in the sun. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight.
  • Kidney Stones: Drink plenty of fluids when using ASACOL HD to decrease your chance of getting kidney stones. Call your doctor right away if you get any of these symptoms: severe pain in your side or your back, or blood in your urine.

The most common side effects of ASACOL HD include:

  • Headache, nausea, nasopharyngitis (common cold), stomach (abdominal) pain, and worsening of UC.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ASACOL HD.


Please see full Prescribing Information for ASACOL HD.


The product information provided on this page is intended only for residents of the United States. The products discussed on this page may have different product labeling outside of the United States.

The health information described on this page is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.

See More

What is ASACOL HD?

ASACOL HD (mesalamine) delayed-release tablets is a prescription medication used to treat moderately active ulcerative colitis (UC) in adults. Safety and effectiveness of ASACOL HD beyond 6 weeks has not been established.

IMPORTANT RISK INFORMATION

Do not take ASACOL HD if you are:

  • allergic to salicylates, or aminosalicylates such as aspirin or medications that contain aspirin
  • allergic to any of the ingredients of ASACOL HD

Before taking ASACOL HD tell your doctor if you:

  • have or have had kidney problems
  • are allergic to sulfasalazine
  • have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)
  • take any iron-containing supplements
  • have or have had liver problems
  • are pregnant, nursing, or are planning to become pregnant or to breastfeed
  • have any other medical conditions

Tell your doctor about all medications you are taking, including prescription and over-the-counter medicinces, vitamins, and herbal supplements. Taking ASACOL HD with nonsteroidal anti-inflammatory drugs (NSAIDs), may cause kidney problems Taking ASACOL HD with azathioprine or 6-mercaptopurine may cause blood problems. Ask your doctor if you are not sure if you are taking one of these medicines.

What are the possible side effects of ASACOL HD?

ASACOL HD may cause serious side effects, including:

  • Kidney problems: Your doctor may check to see how your kidneys are working before taking ASACOL HD.
  • Acute Intolerance Syndrome and Other Allergic Reactions: Some people who use ASACOL HD can have allergic-type reactions, including acute intolerance syndrome. Other allergic reactions can cause heart problems including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body including the kidneys, liver and lungs. When this happens, it is usually in people who have had an allergic reaction to sulfasalazine. Stop using ASACOL HD and contact your doctor right away if you get any of these symptoms: cramping, stomach (abdominal) pain, bloody diarrhea, fever, headache, chest pain, decrease in the amount of urine, shortness of breath, eye inflammation, fatigue, and rash.
  • Liver Failure: This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your doctor right away if you get any of these symptoms while using ASACOL HD: yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting.
  • Sun Sensitivity: ASACOL HD can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. Try to limit your time in the sun. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight.
  • Kidney Stones: Drink plenty of fluids when using ASACOL HD to decrease your chance of getting kidney stones. Call your doctor right away if you get any of these symptoms: severe pain in your side or your back, or blood in your urine.

The most common side effects of ASACOL HD include:

  • Headache, nausea, nasopharyngitis (common cold), stomach (abdominal) pain, and worsening of UC.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ASACOL HD.


Please see full Prescribing Information for ASACOL HD.


The product information provided on this page is intended only for residents of the United States. The products discussed on this page may have different product labeling outside of the United States.

The health information described on this page is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.