Rybelsus (semaglutide tablets): transition to new formulation and risk of medication error

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a Drug Safety Update for Rybelsus (semaglutide) tablets. 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 on the market. The original and new formulations have different stated mg doses but are bioequivalent.

Medication errors may result in overdose if healthcare professionals prescribe more than one tablet per day of the new formulation to try to match the dose to the old strengths. This could affect disease control and increase the risk of side effects.

Healthcare systems are advised that a co-ordinated response is required to manage switching patients to the new formulation. Healthcare professionals should be aware that the original formulation is anticipated to be available until approximately 31st January 2026 however, original formulation stock of imported Rybelsus may be within supply chains beyond this date.

Further information and advice can be found in the Drug Safety Update.