Zelnorm

Irritable Bowel Syndrome

Treatment

5 Active Studies for Zelnorm

What is Zelnorm

Tegaserod

The Generic name of this drug

Treatment Summary

Zelnorm is a medication developed by Novartis that was first approved by the FDA in 2002 to treat irritable bowel syndrome with constipation (IBS-C). In 2007, due to concerns of potential cardiovascular risks, the drug was removed from the US market, but was re-approved in 2019 for female patients under 65 who are at a lower risk of a cardiovascular event. Zelnorm works by targeting serotonin-4 (5-HT(4)) receptors in the gut wall and smooth muscle cells to help with esophageal relaxation, peristaltic gut movement, and natural secretions. However, it is still not

Zelnorm

is the brand name

image of different drug pills on a surface

Zelnorm Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zelnorm

Tegaserod

2002

5

Effectiveness

How Zelnorm Affects Patients

Tegaserod works by activating serotonin type-4 (5-HT(4)) receptors and blocking 5-HT(2B) receptors. It has no effect on 5-HT(1), 5-HT(3) or dopamine receptors. In clinical studies, the drug did not cause a dangerous increase in heart rate, though it did lead to an increase of up to 60 milliseconds in 7% of patients. The same studies showed that tegaserod and its main metabolite could increase platelet aggregation in laboratory tests, but it is unclear what this means for people taking the drug.

How Zelnorm works in the body

Irritable bowel syndrome (IBS) is a condition that causes abdominal pain, bloating, and other uncomfortable issues with the digestive system. One potential way to treat IBS-C (constipation-predominant IBS) is through 5-hydroxytryptamine (5-HT or serotonin). 5-HT can cause the release of chemicals in the gut that help move material through it, as well as relax the esophagus and reduce muscle contraction in the colon. It also helps to create natural fluid secretion in the gut. Tegaserod is a medication that works by activating 5-HT(4) receptors

When to interrupt dosage

The recommended amount of Zelnorm is contingent upon the specified condition. The dosage can be located in the table below, in correlation with the method of administration.

Condition

Dosage

Administration

Irritable Bowel Syndrome

6.0 mg, 2.0 mg,

Tablet, Oral, , Tablet - Oral

Warnings

Zelnorm Contraindications

Condition

Risk Level

Notes

Abdomen

Do Not Combine

Stroke

Do Not Combine

Gall Bladder Diseases

Do Not Combine

Angina Pectoris

Do Not Combine

Colitis, Ischemic

Do Not Combine

History of bowel obstruction

Do Not Combine

Transient Ischemic Attack

Do Not Combine

History of forms of intestinal ischemia

Do Not Combine

Severe Hepatic Impairment

Do Not Combine

Kidney Failure

Do Not Combine

Moderate Hepatic Impairment

Do Not Combine

Sphincter of Oddi Dysfunction

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Tegaserod may interact with Pulse Frequency

There are 20 known major drug interactions with Zelnorm.

Common Zelnorm Drug Interactions

Drug Name

Risk Level

Description

Acenocoumarol

Major

The metabolism of Acenocoumarol can be decreased when combined with Tegaserod.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Tegaserod.

Amiodarone

Major

The metabolism of Amiodarone can be decreased when combined with Tegaserod.

Anagrelide

Major

The metabolism of Anagrelide can be decreased when combined with Tegaserod.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Tegaserod.

Zelnorm Toxicity & Overdose Risk

Taking more than the recommended dose of Tegaserod can cause diarrhea, headaches, abdominal pain, flatulence, nausea, and vomiting. Pregnant women should be cautious when taking Tegaserod, as animal studies have shown decreased body weight, delays in developmental landmarks, and decreased survival in rat pups. Breastfeeding is not recommended while taking Tegaserod due to the potential for serious reactions in the breastfed infant. The safety and effectiveness of Tegaserod in pediatric patients and those over the age of 65 has not been established. In animal studies, there was no evidence of carcinogenicity at lower doses but mucosal hyperpl

image of a doctor in a lab doing drug, clinical research

Zelnorm Novel Uses: Which Conditions Have a Clinical Trial Featuring Zelnorm?

Four ongoing trials are investigating the potential of Zelnorm to provide relief from Constipation-predominant Irritable Bowel Syndrome (IBS-C).

Condition

Clinical Trials

Trial Phases

Irritable Bowel Syndrome

3 Actively Recruiting

Phase 2, Phase 3

Zelnorm Reviews: What are patients saying about Zelnorm?

5

Patient Review

12/1/2010

Zelnorm for Chronic Difficulty having a Bowel Movement

This treatment is really effective for those suffering from IBS. It helped me a lot and I only take it now when I have a flare up. The FDA made a mistake by making this unavailable to people.

5

Patient Review

6/20/2011

Zelnorm for Irritable Bowel Syndrome with Constipation

This drug is the only one that has ever kept me free of obstruction, pain, and hospitalization. I was told 4 years ago that it had been taken off the market and I have had another severe attack again, severe pain, distention , projectile vomiting.

5

Patient Review

1/8/2011

Zelnorm for Irritable Bowel Syndrome with Constipation

This medication was a complete game-changer for me when I first took it. I had no idea that I was constipated before, and this drug provided such amazing relief. It also helped me lose weight, which was an added bonus.

5

Patient Review

4/20/2014

Zelnorm for Irritable Bowel Syndrome with Constipation

I was taking Zelnorm for three years before it was taken off the market. I'm devastated that I can't get it anymore; it did wonders for me, making me feel like a normal person who could do things other people take for granted. Now I use an herbal supplement with senna in it, even though I know I shouldn't because of the potential side effects. Has anyone had any luck buying Zelnorm from other countries?

5

Patient Review

9/24/2013

Zelnorm for Irritable Bowel Syndrome with Constipation

IBS was a twenty year nightmare for me, and this medication finally put an end to most of it. For five wonderful years I was able to live relatively symptom-free. But now it's back and there's nothing else like it on the market. We need to find a way to get this treatment available again!

5

Patient Review

4/14/2014

Zelnorm for Chronic Difficulty having a Bowel Movement

Zelnorm was effective for me and I experienced no negative side effects.

5

Patient Review

9/16/2019

Zelnorm for Irritable Bowel Syndrome with Constipation

I'm so glad Zelnorm is back on the market!

5

Patient Review

11/3/2010

Zelnorm for Irritable Bowel Syndrome with Constipation

I'm really hoping that Zelnorm makes a comeback soon. It worked great for me and I haven't been able to find anything else that works as well.

5

Patient Review

8/17/2013

Zelnorm for Chronic Difficulty having a Bowel Movement

I want ZELNORM back on the market! The only over-the-counter medication I have found that is somewhat compatible is magnesium citrate, but I can only take it once a week. Two women complained and they took it off the market?

5

Patient Review

3/22/2010

Zelnorm for Chronic Difficulty having a Bowel Movement

5

Patient Review

4/29/2010

Zelnorm for Irritable Bowel Syndrome with Constipation

5

Patient Review

2/1/2012

Zelnorm for Chronic Difficulty having a Bowel Movement

Zelnorm was an amazing drug that really helped with my chronic constipation. I haven't been able to find anything that works as well since it was taken off the market.

5

Patient Review

9/13/2013

Zelnorm for Irritable Bowel Syndrome with Constipation

I was really struggling before I found this medication, and it honestly changed my life for the better. I'm so disappointed that it's no longer available; it was the only thing that ever helped me.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about zelnorm

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is ZELNORM?

"Zelnorm is a prescription medicine used to treat the symptoms of Irritable Bowel Syndrome (IBS) with Constipation. Zelnorm may be used alone or as an adjunct to other medications. Zelnorm is a member of a class of agents referred to as IBS Agents."

Answered by AI

How quickly does ZELNORM work?

"Zelnorm may start to improve symptoms within one week. However, if there is no improvement after four to six weeks, speak to a healthcare provider as a different medication may be required."

Answered by AI

What is ZELNORM prescribed for?

"ZELNORM™ is a prescription medication used to treat adult women less than 65 years of age with IBS-C."

Answered by AI

Why ZELNORM was taken off the market?

"- Zelnorm, a drug used to treat constipation caused by irritable bowel syndrome, has been recalled due to an increased risk of heart attack, stroke, and death. This was announced by U.S. health officials on Friday, March 30."

Answered by AI

Clinical Trials for Zelnorm

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