The FDA Adverse Event Reporting System (FAERS) contains over nine million reports of adverse events and reflects data from 1969 to the present. FDA moved data from our legacy system (AERS) to FAERS on August 28, 2012.
Data from FAERS are presented here as summary statistics. These summary statistics cover data received over the last ten years. These data are presented at the individual report level; some of the numbers may reflect duplicate reporting due to factors such as follow-up reports received on a case or different persons reporting on the same patient case. We will update these data files each quarter; therefore, the most recent year displayed may contain only partial year data.
- Reports Received and Reports Entered into FAERS by Year. Number of reports received by FDA and entered into FAERS by type of report since the year 2004.
- Domestic and Foreign Reports by Year. Number of domestic (U.S.) and foreign reports in FAERS since the year 2004.
- Reporting by Healthcare Providers and Consumers by Year. Number of reports in FAERS by type of reporter (Healthcare Professional [HCP] or consumer) since the year 2004.
- Reporting by Patient Outcomes by Year. Patient outcome(s) for reports in FAERS since the year 2004. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.