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Rybelsus® (oral semaglutide) update: Transition to new formulation and risk of medication error

NCL Wide

The Medicines and Healthcare Regulatory Agency (MHRA) has updated the safety information for Rybelsus® (semaglutide tablets) due to a transition to new formulation.

There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus® tablets will both be available to prescribe and in the supply chain. The new formulation of Rybelsus® has increased bioavailability therefore lower strength tablets achieve the same drug exposure and clinical effect as the previous formulation.

Healthcare providers to refer to the drug safety update for full details.

The NCL ICB's Medicines Optimisation Team, jointly with the NCL Diabetes Network and system partners have issued a detailed system-wide communication regarding the introduction of a new formulation of Rybelsus® (semaglutide tablets). The guidance was developed to support prescribers and dispensers. It provides risk minimisation strategies and guidance on switching patients on the original formulation of Rybelsus® (semaglutide tablets) to the new formulation and covers the MHRA advice. The NCL guidance and recommended advice is below. 

The two formulations will temporarily co-exist on the market until approximately 31 January 2026. However, original formulation stock of imported Rybelsus® may be within supply chains beyond this date.

Report medication errors or near misses via local risk management systems and medication errors resulting in patient harm on the MHRA Yellow Card reporting site.

ScriptSwitch® messages have been enabled to provide information to support primary care.

This item was updated on 24 December 2025 to highlight the MHRA safety information update.

This item was updated on 18 November 2025 to highlight the introduction of the newly changed formulation of Rybelsus® (oral semaglutide) on that date. NCL ICS supporting information is available for prescribers.

Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication error (MHRA, December 2025)


Safety information update
https://www.gov.uk
November 2025

Diabetes: Rybelsus® - oral semaglutide formulation change NCL ICS supporting information

NCL Wide
Expiry date: Tuesday, 31 March 2026