FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports¹. All FAERS reports are easily accessible to the public.  

FAERS is utilized to look for safety concerns of a product and evaluate the manufacturer’s compliance. If a safety concern is identified through the event reporting system additional evaluation for the product is completed. The FDA can take regulatory actions to ensure the safety and effectiveness of the product to protect overall public health.  

Consumers, manufacturers, and healthcare professionals can easily submit a report to FAERS. if a manufacturer receives a report from a consumer or healthcare provider, they are required to transfer the report to the FDA for submission. All adverse event reporting is completed through electronic submissions. The FAERS data has limitations on the factors that can influence whether an even or error occurred with the product. Some factors include the time the product has been marketed, the publicity of the event, and the recurrence of an event.  

All adverse event reports from 1968 to the present can be easily acquired through the FAERS public dashboard¹. A user can view the summary of adverse event reports and search based on their product of interest within any timeframe since 1968. If you or your company needs assistance with submissions of adverse events or any other aspects of FAERS, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.  

^{1FDA (June 2018) FDA’s Adverse Event Reporting System (FAERS), retrieved on June 27, 2022, from https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers}