FOI release

Enquiry N. 171103 - Incidence of QT interval prolongation on high dose Loperamide

Case reference FOI2025/01281

Received 8 December 2025

Published 29 January 2026

Request

I would like to please request some specific data on Yellow card reports. We are currently looking into the incidence of QT interval prolongation in patients on high dose loperamide (taking more than 4mg QDS) for high output stoma/fistula. I can see the number of Torsades de pointes have been reported on the MHRA iDAPs website but would like to know how many of these are related to high dose loperamide. Please could you provide us with the number of QT interval prolongation yellow card reports that have been associated with taking high dose of loperamide (taking more than 4mg QDS).

Response

See attached

Documents

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.