FDA released the fourth quarter of Adverse Event Reporting System (FAERS) data on Thursday March 16th.  By Monday March 20th, our team had run the data through our proprietary RxFiler optimization process and the de-duplicated, cleaned, and properly cataloged data were onto our Evidex platform and ready for use by our clients.

For the fourth quarter, we processed 310,222 new unique case reports, which brought the total new unique case reports for 2016 to 1,253,464.

While a full analysis of our Q4 findings is still pending, it’s clear that the sheer volume of case reports continues to grow rapidly. 

Our infographic below provides some key details:


2016 FAERS Data Infographic_Advera Health.png

We’ve discussed our theories on why that growth is accelerating in past blog posts.  The rapid rise even made the mainstream press recently an article in USA Today and a follow-up in industry trade publication FiercePharma.

FAERS remains the best – and only – full deployed early warning system for post-approval drug safety monitoring.  As the volume of FAERS data increases, the importance of proper data management and analysis also increases. 

If you’re interested in learning more about our data management processes, our proprietary safety signaling technology, or our FAERS integrations with clinical trial data or internal safety and claims data, please contact us here.

Topics: FAERS

Brian Overstreet

Written by Brian Overstreet