Zelnorm (tegaserod) is a prescription medication for women with irritable bowel syndrome with constipation (IBS-C). Zelnorm is for women less than 65 years old. Zelnorm was previously on the market until it was voluntarily withdrawn in 2007 due to safety concerns. A complete safety review was completed by the United States Food and Drug Administration and a committee called the Gastrointestinal Drugs Advisory Committee (GIDAC). The thorough review concluded the Zelnorm was safe for use in individuals with IBS-C, and in 2019, Zelnorm was reintroduced into the market.1
Zelnorm is a selective serotonin type-4 (5-HT4) receptor agonist and is the only one of its kind currently available for IBS-C. By activating this specific serotonin receptor on cells in the gastrointestinal tract, Zelnorm increases and stabilizes gut motility and intestinal secretions to increase the frequency of bowel movements. It also inhibits aspects of gut sensitivity, potentially decreasing the abdominal pain that can come along with IBS-C.1,2
The recommended dose of Zelnorm is 6 mg taken two times a day. The medication comes in a tablet form that is taken orally, and should be administered at least 30 minutes before meals. It is important to take Zelnorm exactly how it is prescribed and to seek emergency medical attention if you take too much of the medicine. If there is no improvement in IBS-C symptoms after four to six weeks of treatment, the medication should be discontinued.
Who shouldn’t take Zelnorm
At this time, the safety and efficacy of Zelnorm in men and children with IBS-C is not known, and these groups should not take this medication. Women over 65 years old should also not take Zelnorm.
Zelnorm may cause serious side effects including major cardiovascular events, inflammation or injury of the intestines, profuse diarrhea, and suicidal thoughts or behaviors. For this reason, individuals who have one or more of the following conditions should not take Zelnorm:
History of a cardiovascular event, including a stroke, heart attack, transient ischemic attack, or angina (chest pain)
Ischemic colitis (a lack of blood flow to the intestines) or a history of other inflammatory conditions within the intestines
End-stage kidney disease or severe kidney problems
Moderate or severe liver problems
Dysfunction of any intestinal valves or a past intestinal blockage (bowel obstruction)
Past surgeries or other conditions that may have led to significant scar tissue in the abdomen
Zelnorm’s effects on an unborn baby are unknown, and therefore, Zelnorm may not be appropriate for use in pregnant women. Additionally, it is not known if Zelnorm can pass into breastmilk, and should not be used when breastfeeding. Talk to your doctor or healthcare provider if you are currently pregnant, planning to become pregnant, or breastfeeding before or while taking Zelnorm.
Possible side effects when taking Zelnorm
Aside from the rare, serious side effects previously listed that Zelnorm can cause, there have been other, more common and less severe side effects reported while taking the medication. These include, but are not limited to:
Individuals who experience severe diarrhea or changes in the mood or behavior should contact their doctor or healthcare provider immediately.1
Additional treatment options for IBS
There are other medical and alternative treatment options for IBS. Since a serotonin imbalance may cause IBS symptoms, some individuals may benefit from treatment with anti-depressants or other kinds of serotonin-impacting medications. Depending on an individual’s specific IBS symptoms, treatment with antispasmodic medications, antibiotics, antidiarrheal medications, or anti-anxiety therapies may be helpful.
In addition to traditional treatment options, alternative therapies and lifestyle modifications may also be beneficial for those with IBS. Some of these include exercise, dietary changes, adding fiber, acupuncture, and more. It is often a trial and error process to determine which treatment options provide the most relief.
FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65. PR Newswire. https://www.prnewswire.com/news-releases/fda-approves-the-reintroduction-of-zelnorm-tegaserod-for-irritable-bowel-syndrome-with-constipation-ibs-c-in-women-under-65-300821611.html. Published April 1, 2019. Accessed April 22, 2019.
Zelnorm Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021200Orig1s015lbl.pdf. Published March 2019. Accessed April 2019.