Is Tegaserod approved by the US FDA?

Drugs@FDA lists 1 application product line for Tegaserod, including ZELNORM (Discontinued).

Is Tegaserod authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Tegaserod.

Are there safety signals or safety updates for Tegaserod?

US FDA: 1 entry (latest 2019-03-29).

Active substance

Tegaserod

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZELNORM	EQ 2MG BASE; EQ 6MG BASE	tablet · oral	ALFASIGMA	Discontinued	24 Jul 2002

EMA European Union — centrally authorised medicines

Zelnorm Novartis Europharm Limited · Refused · ATC A03AE02

Therapeutic indication (EMA)

Zelnorm is indicated for the repeated symptomatic short-term treatment of women with Irritable Bowel Syndrome (IBS) whose predominant bowel habit is constipation, associated with abdominal pain/discomfort or bloating (see section 4.2).

Safety signals and safety-related labeling changes

US FDA 29 Mar 2019 ZELNORM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tegaserod →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.