U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS): Archived Reports
  1. Surveillance: Post Drug-Approval Activities

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS): Archived Reports

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS): Archived Reports

The following reports list potential signals of serious risks/new safety information that were identified using the FAERS database during the indicated quarter. Data from AERS was moved to FAERS for the launch of FAERS on September 10, 2012.

After FDA has either determined that no regulatory action is required or has taken a regulatory action for each issue on a quarterly report, we will stop updating it and will add it to the list of archived reports on this page.

Archived Quarterly Reports

FDA is no longer updating these reports.

2013

2011

2010

2009

2008