European Medicines Agency releases a public database of suspected adverse drug reaction reports

In May 2012 the European Medicines Agency launched the new website publishing suspected side-effect reports of drugs authorised in the European Economic Area. The website for the general public is available in all official European languages.

Excerpt from the press release of the European Medicines Agency, 31 May 2012

“The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. (…)

Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines. (…)

A web report does not include reports from studies (e.g. clinical trials and non-interventional studies) or other types of reports, i.e. they only include spontaneous reports.”

European Medicines Agency boosts EU transparency with online publication of suspected side effect reports
European database of suspected adverse drug reaction reports