What is Colazal used for?

Colazal is used to treat the signs and
symptoms of mild to moderately active ulcerative colitis. The safety and efficacy of
Colazal are not known after 12 weeks.

Who should not take Colazal?

You should not take Colazal if you are allergic to medicines containing:

• salicylates, such as aspirin
• mesalamine (Rowasa®, Asacol®, or Pentasa®)

General Precautions with Colazal:

Some people experience a worsening of their colitis symptoms possibly related to
the use of Colazal.

What should I tell my doctor or health care provider?

Tell your doctor or health care provider if you have kidney disease or a history
of kidney problems. Patients taking products that contain the same active ingredient as
Colazal have sometimes had kidney problems.

Tell your health care provider if you are trying to become pregnant, are already
pregnant, or are breast-feeding.

Tell your health care provider if you have pyloric stenosis, a narrowing of the
muscle that controls the emptying of the stomach.

Because certain other medications such as antibiotics may interact with Colazal,
review all medications that you are taking with your health care provider, including those
that you take without a prescription.

What are some possible side effects of Colazal? (This is NOT
a complete list of side effects reported with Colazal. Your health care provider can
discuss with you a more complete list of side effects.)  

Common side effects include:

• Headache
• Stomach pain
• Nausea
• Diarrhea

Reports of patients’ experience with similar products:

In patients taking products that contain the same active ingredient as
Colazal (mesalamine), several serious liver-related side effects have been reported,
including abnormal liver function tests, jaundice, cirrhosis, liver damage, and liver
failure. It is not possible to determine how often these side effects occur or whether
these events are directly related to the active ingredient.

For more detailed information about Colazal, ask your health care provider.

http://www.fda.gov/cder/foi/label/2000/20610lbl.pdf    Link to
Colazal’s Labeling 

Posted: 6/18/01