Possible side effects

DELZICOL may not work the same for everyone, and some people experience side effects. These are some of the risks associated with medicines containing mesalamine to treat ulcerative colitis (UC).

Make sure you understand the possible side effects and what to look out for. Tell your doctor immediately if you are experiencing any side effects.

The most common adverse reactions (observed in greater than or equal to 5% of adults in clinical trials)1:

  • belching
  • stomachache
  • constipation
  • dizziness
  • runny nose
  • back pain
  • rash

The most common adverse reactions (observed in greater than or equal to 5% of children 5 years and older in clinical trials)1:

  • inflammation of nose and throat
  • headache
  • stomachache
  • dizziness
  • inflammation of sinuses
  • rash
  • cough
  • diarrhea
  • tiredness
  • fever
  • increased lipase

Some people reported seeing the medicine capsule shell in their stool—either partially or fully intact. Tell your doctor immediately if this happens to you repeatedly.

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  • Reference

  • 1.
    Delzicol [package insert]. Parsippany, NJ: Warner Chilcott (US), LLC; 2015.
  • See More Important Risk Information

    IMPORTANT RISK INFORMATION

    Who should not take DELZICOL?

    • Do not take DELZICOL if you are allergic to:
      • salicylates, such as aspirin or medications that contain aspirin
      • aminosalicylates
      • any of the ingredients of DELZICOL

    What should I tell my healthcare provider before taking DELZICOL?

    Tell your healthcare provider 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
    • Have or have had a stomach blockage
    • Have any other medical conditions

    What are the possible side effects of DELZICOL?

    DELZICOL may cause serious side effects, including:

    • Kidney problems: Your doctor may check to see how your kidneys are working before taking DELZICOL. It is important to complete all blood tests ordered by your doctor.
    • A condition that may be hard to tell apart from a UC flare: Symptoms include cramping, stomachache, bloody diarrhea, and sometimes fever, headache, and rash. If you experience any of these symptoms while on treatment, call your doctor right away. He or she may tell you to stop taking DELZICOL.
    • Hypersensitivity (allergic) reactions: If signs and symptoms of hypersensitivity occur, immediately call your doctor.
    • Liver failure: In patients that have or have had liver disease.
    • Blood Disorders: Elderly patients and patients taking azathioprine or 6-mercaptopurine need to monitor complete blood cell counts and platelet counts while taking DELZICOL.

    The most common side effects of DELZICOL include:

    • Adults: belching, stomachache, constipation, dizziness, runny nose, back pain, rash, upset stomach, and flu symptoms.
    • Children (5 to 17 years of age): inflammation of the nose and pharynx, headache, stomachache, dizziness, inflammation of the sinuses, rash, cough, diarrhea, tiredness, fever, and increased lipase.

    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 DELZICOL.

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

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

    What is DELZICOL?

    DELZICOL (mesalamine) delayed-release capsules is a prescription medication approved for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older and for the maintenance of remission of UC in adults.

    Please see full Prescribing Information for DELZICOL.

    To report a side effect from one of our products, please call the Allergan Drug Safety Department at 1-800-678-1605.

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