Side effects and trials

An unwanted effect of medicines or healthcare products. Everybody can report side effects to the Danish Health and Medicines Authority.

Clinical trials are undertaken to find out how a particular medicine works, what side effects it causes and how it is metabolised in the body.

Known or unknown events, incidents or errors occurring in connection with healthcare activities or in connection with the supply of or information about medicines.

A periodic safety update report (PSUR) is a report describing the safety of a medicinal product.

A Direct Healthcare Professional Communication serves the purpose of supporting safe and effective use of medicines, and it is sent out when new important safety information about a medicine has been obtained.