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
  • 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

IMPORTANT RISK INFORMATION

Do not take ASACOL HD if you are:

  • allergic to salicylates, such as aspirin or medications that contain aspirin
  • allergic to aminosalicylates
  • 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)
  • have or have had liver problems
  • are pregnant, nursing, or are planning to become pregnant or to breastfeed
  • have any other medical conditions

What are the possible side effects of ASACOL HD?

ASACOL HD may cause serious side effects, including:

  • Kidney problems: Reports of problems with kidney function have been associated with mesalamine-containing products like ASACOL HD. Your doctor may check to see how your kidneys are working before starting and periodically while taking ASACOL HD.
  • Acute Intolerance Syndrome: Products that contain mesalamine, like ASACOL HD, have been associated with a condition, Mesalamine-Induced Acute Intolerance Syndrome, that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach-area (abdominal) pain, bloody diarrhea, and occasionally fever, headache, tiredness, itching, rash, and conjunctivitis. If you experience any of these symptoms while on treatment, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
  • Allergic reactions, including inflammation of the heart muscle or lining: Allergic reactions may involve internal organs, including inflammation of the heart muscle (myocarditis), inflammation of the lining of the heart (pericarditis), inflammation of the kidneys (nephritis), inflammation of the liver (hepatitis), inflammation of the lungs (pneumonitis), and blood abnormalities. If you experience any allergic reaction symptoms, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
  • Liver failure: Reports of liver failure have been associated with mesalamine-containing products like ASACOL HD in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.

The most common side effects of ASACOL HD include:

  • Headache, nausea, nasopharyngitis (common cold), stomach-area (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.

Before starting ASACOL HD, tell your doctor about all medications you are taking, including:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen. Taking these medications with ASACOL HD may increase your risk of kidney problems.
  • Azathioprine or 6-mercaptopurine. Taking these medications with ASACOL HD may increase your risk of blood disorders.

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.


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

IMPORTANT RISK INFORMATION

Do not take ASACOL HD if you are:

  • allergic to salicylates, such as aspirin or medications that contain aspirin
  • allergic to aminosalicylates
  • 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)
  • have or have had liver problems
  • are pregnant, nursing, or are planning to become pregnant or to breastfeed
  • have any other medical conditions

What are the possible side effects of ASACOL HD?

ASACOL HD may cause serious side effects, including:

  • Kidney problems: Reports of problems with kidney function have been associated with mesalamine-containing products like ASACOL HD. Your doctor may check to see how your kidneys are working before starting and periodically while taking ASACOL HD.
  • Acute Intolerance Syndrome: Products that contain mesalamine, like ASACOL HD, have been associated with a condition, Mesalamine-Induced Acute Intolerance Syndrome, that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach-area (abdominal) pain, bloody diarrhea, and occasionally fever, headache, tiredness, itching, rash, and conjunctivitis. If you experience any of these symptoms while on treatment, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
  • Allergic reactions, including inflammation of the heart muscle or lining: Allergic reactions may involve internal organs, including inflammation of the heart muscle (myocarditis), inflammation of the lining of the heart (pericarditis), inflammation of the kidneys (nephritis), inflammation of the liver (hepatitis), inflammation of the lungs (pneumonitis), and blood abnormalities. If you experience any allergic reaction symptoms, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
  • Liver failure: Reports of liver failure have been associated with mesalamine-containing products like ASACOL HD in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.

The most common side effects of ASACOL HD include:

  • Headache, nausea, nasopharyngitis (common cold), stomach-area (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.

Before starting ASACOL HD, tell your doctor about all medications you are taking, including:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen. Taking these medications with ASACOL HD may increase your risk of kidney problems.
  • Azathioprine or 6-mercaptopurine. Taking these medications with ASACOL HD may increase your risk of blood disorders.

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.

Please see full Prescribing Information for ASACOL HD.

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