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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Gastroenterology | Family Medicine | Infections and Infectious Diseases

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Zelnorm (tegaserod maleate) Tablets

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Novartis
Approval Status: Approved July 2002
Treatment Area: irritable bowel syndrome (IBS)

General Information

Zelnorm aids in the movement of stools through the bowels by selectively activating 5HT4 receptors present throughout the gastrointestinal tract. Zelnorm has been approved by the FDA for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation as their main symptom. Other problems associated with IBS include abdominal pain and bloating. Although Zelnorm treats the symptoms of IBS, it is not a cure for the disorder.

Clinical Results

Three multicenter, double blind, placebo-controlled studies evaluated Zelnorm in 2,470 women with irritable bowel syndrome (IBS) symptoms, namely abdominal pain, bloating and constipation. Two studies were fixed dose studies and the third was a dose-titration study. In all three studies Zelnorm was administered for 12 weeks and efficacy was evaluated based on patients' ratings of their relief of symptoms and the intensity of symptoms. Zelnorm-treated patients reported greater relief from symptoms and greater increase in number of stools than placebo-treated patients, with the difference being largest during the first four weeks.

Side Effects

Adverse events associated with the use of Zelnorm (tegaserod maleate) may include (but are not limited to) the following:


  • Abdominal pain
  • Diarrhea
  • Nausea
  • Flatulence
  • Headache
  • Dizziness
  • Back pain
  • Influenza-like symptoms

Mechanism of Action

Tegaserod is a partial agonist that binds with high affinity at human 5-HT4 receptors, whereas it has no appreciable affinity for 5-HT3 or dopamine receptors. It has moderate affinity for 5-HT1 receptors. Tegaserod, by acting as an agonist at neuronal 5-HT4 receptors, triggers the release of further neurotransmitters such as calcitonin gene-related peptide from sensory neurons. The activation of 5-HT4 receptors in the gastrointestinal tract stimulates the peristaltic reflex and intestinal secretion, as well as inhibits visceral sensitivity (From FDA Label).

Additional Information

For additional information on Zelnorm, please visit www.zelnorm.com.