The European Medicines Agency's central database for adverse drug reaction reporting across the EU
EudraVigilance is the European Medicines Agency's (EMA) centralised database for adverse drug reaction (ADR) reports from across the European Union. It serves as the primary pharmacovigilance infrastructure for the EU's 27 member states, enabling coordinated signal detection and regulatory response at a pan-European level.
Covers all 27 EU member states plus EEA countries (Iceland, Liechtenstein, Norway). All nationally authorised and centrally authorised medicines including vaccines are monitored.
Operated by the European Medicines Agency (EMA) in Amsterdam. EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviews safety signals identified in EudraVigilance.
The European database of suspected adverse drug reactions (www.adrreports.eu) provides public access to aggregated ADR data for all medicines with EU marketing authorisation.
EudraVigilance data directly informs PRAC assessments, European Public Assessment Reports (EPARs), and regulatory decisions including label updates and market withdrawals.
EMA. "EudraVigilance." European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance/eudravigilance
EMA. "European database of suspected adverse drug reaction reports." https://www.adrreports.eu
EMA. "Pharmacovigilance Risk Assessment Committee (PRAC)." European Medicines Agency. https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac
EMA. "COVID-19 vaccine safety updates." European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines