Pharmacovigilance

An adverse drug reaction is an adverse effect which may develop when medicinal products are consumed. Medicinal products can, for example, cause headache, abdominal pain, convulsion or rash.

A package leaflet is included in all medicinal product packages. This leaflet informs about the effect of the medicinal product and known adverse reactions of this product. Additional information is available in the summary of the product characteristic (SPC) via the search function of the website. The information in the product characteristics is primarily aimed at health-care professionals.

The Danish Medicines Agency collects and handles reports of adverse reactions in the way that both pharmaceutical companies and authorities of other countries will be informed of possible adverse reactions of medicinal products. It is the responsibility of the Danish Medicines Agency to make sure that the pharmaceutical industry acts on the adverse drug reactions reported.

In the fact box to the right The Danish Medicines Agency informs about current problems with adverse drug reactions.