Report an adverse drug reaction

EudraVigilance is a shared database of adverse drug reactions used by medicines agencies in the European Economic Area.

Medicines agencies in the European Economic Area and marketing authorisation holders are required to submit the reports they receive to the shared adverse drug reaction database of the European Medicines Agency (EMA), EudraVigilance (EV). Adverse reaction reports enable health authorities to monitor the safety of medicines, and reviewing all reports increases knowledge of the safety and effectiveness of medicines.

Statistics on adverse reaction reports

The general public and healthcare professionals can access information in the publicly accessible part of the EudraVigilance database. It provides information on the number of adverse reactions reported to EV concerning medicines authorised in the European Economic Area.

Questions about EudraVigilance can be directed to the Icelandic Medicines Agency (IMA).

• For medicines granted a marketing authorisation by EMA, searches can be made by medicine name or active substance. For medicines with a national marketing authorisation, searches can only be made by active substance. The information on the website concerns suspected adverse reactions, namely unwanted symptoms observed during the use of a medicine that are not necessarily related to the medicine itself.

• Information on suspected adverse reactions must not be interpreted as meaning that the medicine or its active substance is unsafe to use. Conclusions about the benefits and risks of medicines can only be drawn through scientific assessment.

• EMA publishes this data to give stakeholders and the general public easy access to information used by health authorities to assess the safety of medicines.

• It is important to consider data from the database in the context of the medicine’s known adverse reactions, as listed in the Summary of Product Characteristics (SmPC) or package leaflet.