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Wondering how drug adverse reactions are reported after the product goes to market? The FDA’s Adverse Event Reporting System (FAERS) contains adverse event reports from manufacturers (required by regulation) as well as reports from consumers and healthcare professionals.

How does the FDA use FAERS? If a safety concern is made, the FDA may take regulatory action to improve product safety such as updating a product’s labeling info, restricting the use of the drug, communicating new safety info to the public, or removing the product from the market.

If you experience an adverse reaction after accepting a product, the FDA wants you to report it!

How are reports made? Per the FDA, health care providers are not required to report adverse reactions to the FDA. Because of this, adverse reactions are largely underreported (more later), however as a patient or consumer you can report an adverse reaction online through MedWatch (see below).

Can I search FAERS reports? Yes! FAERS data is available to the public through a dashboard which is interactive, best on desktop, and has reports from 1968 to present available. Data files are also available which are raw data and harder to search query.

If you are researching a specific drug, FAERS is an excellent tool, however, understand it is a passive surveillance system. Its accuracy is based on the people that input the reports. If individuals do not report reactions, then it will be hard to fully grasp the frequency or seriousness of adverse reactions.

Can you search FAERS for vaccine adverse reactions? No, there is a whole separate reporting system for vaccines. Head to the next section to learn everything you need to know about vaccines!