Is Zelnorm back on the market?

Q: Is Zelnorm back on the market?

Yes . The FDA approved the reintroduction of Zelnorm (tegaserod) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65 years of age, in late March 2019. It is expected to become available in the months following the announcement. Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. In March 2007, Zelnorm was voluntarily withdrawn from the U.S. market because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with those who were treated with a placebo. In July 2007, the FDA announced that it was permitting the restricted use of Zelnorm for certain patients when there was no satisfactory alternative treatment available. In March 2019, the FDA approved the reintroduction of Zelnorm for the treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Approval came after a complete safety review by the FDA and the Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.

Medically reviewed by Drugs.com. Last updated on March 25, 2025.

Official Answer by Drugs.com

Zelnorm was withdrawn from the U.S. market in 2007. Has it been reintroduced?

Yes. The FDA approved the reintroduction of Zelnorm (tegaserod) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65 years of age, in late March 2019.

It is expected to become available in the months following the announcement.

Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women.
In March 2007, Zelnorm was voluntarily withdrawn from the U.S. market because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with those who were treated with a placebo.
In July 2007, the FDA announced that it was permitting the restricted use of Zelnorm for certain patients when there was no satisfactory alternative treatment available.
In March 2019, the FDA approved the reintroduction of Zelnorm for the treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Approval came after a complete safety review by the FDA and the Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.

How long do venlafaxine withdrawal symptoms last?

Venlafaxine withdrawal symptoms typically last up to 3 to 4 weeks, but may persist even longer. You should avoid abruptly stopping venlafaxine treatment unless otherwise directed by your healthcare provider. Gradually reducing the dose over 4 weeks can help to prevent severe withdrawal symptoms in most people. Continue reading

Is psyllium husk an affordable weight loss option to Ozempic?

While psyllium husk products like Metamucil may be more affordable than Ozempic, it may not be an equivalent alternative for weight loss. Head-to-head studies have not been done to compare these products, they have different actions in the body and separate studies have shown greater weight loss with Ozempic. Continue reading

What is Trimebutine used for?

Trimebutine relieves abdominal pain and helps to restore normal bowel function and may be used to treat motility disorders of the gastrointestinal tract such as irritable bowel syndrome and paralytic ileus after abdominal surgery. It is an antispasmodic. Continue reading

Is Zelnorm back on the market?

Read next

How long do venlafaxine withdrawal symptoms last?

Is psyllium husk an affordable weight loss option to Ozempic?

What is Trimebutine used for?

See also:

Aimovig

Botox

Trodelvy

Nurtec ODT

Vyepti

Depakote

Topamax

Emgality

Inderal

Ajovy

Related medical questions

Drug information

Related support groups