Patient Information Sheet
Tegaserod Meleate (marketed as Zelnorm)

This is a summary of the most important information about Zelnorm. For details, talk to your healthcare professional.

What is Zelnorm used for? 

Zelnorm is used for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem.  Zelnorm has not been shown to work in men with IBS. 

Zelnorm is also used for chronic idiopathic constipation (frequent constipation of unknown cause) in both male and female patients less than 65 years of age.

Who should not take Zelnorm?

You should not start taking Zelnorm if you: 

• have diarrhea or have diarrhea often 
• have bad kidney or liver disease 
• have ever had bowel obstruction (intestinal blockage), symptomatic gallbladder disease, or abdominal adhesions causing pain and/or intestinal blockage 
• are allergic to Zelnorm or any of its ingredients

What should I tell my doctor or healthcare provider?

Tell your doctor or healthcare provider if you are: 

• trying to become pregnant, are already pregnant, or are breast-feeding. Zelnorm is not recommended for use by pregnant women or women who are breast-feeding 
• are taking or planning to take any other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements

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

The most common side effects are: 

• headache 
• abdominal pain 
• diarrhea 
• nausea 
• "gas" (flatulance) 

 Reports of patients’ experience after Zelnorm became available:

Too little blood flow to the colon leading to inflammation (ischemic colitis) and other forms of intestinal blood flow problems have been reported in patients receiving Zelnorm after the drug became available.  In some cases, hospitalization was needed and even death occurred.  Zelnorm should be stopped immediately in patients who develop symptoms of ischemic colitis, such as rectal bleeding, bloody diarrhea, or new/worsening stomach pain.  Treatment with Zelnorm should not be restarted in patients who are determined to have ischemic colitis or other forms of intestinal blood flow problems after taking Zelnorm.

For more detailed information about Zelnorm, ask your healthcare provider or pharmacist.

Link to Zelnorm's Approved Labeling and Patient Information 

Back to Top     Back to Drug Index

Date created: January 10, 2003

Updated:  August 22, 2006

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research