Adverse Events & The Adverse Event Reporting System
The Adverse Event Reporting System (AERS) is a database
designed to support the FDA's post-marketing safety surveillance program for all
approved drug and therapeutic biologic products. The ultimate goal of AERS is to
improve the public health by providing the best available tools for storing and
analyzing safety reports.
FDAble provides the only public search engine for AERS data.
Download Sample AERS Report.
See limitations of interpreting AERS data.
Reference:
FDA Web-site.