The FDA’s Drug Adverse Event Database Is Now Updated in Real Time: Here’s How to Use It

On Friday, August 22, the Food and Drug Administration (FDA) announced in a press release that it would begin updating its Adverse Events Reporting System (FAERS) in real time, replacing the agency’s previous quarterly update schedule. The agency said the change “demonstrates [the FDA’s] commitment to radical transparency and real-time protection of public health.”

Patients, doctors, and even family members can submit reports directly to the FAERS database if they suspect a symptom is related to a medication. Reports can include both side effects and cases where a medication that once worked no longer seems effective.

To report your experience to FAERS, click here.

FDA scientists routinely monitor the database for patterns of serious side effects or signs of inefficacy that warrant further investigation. Those investigations can lead the agency to add new warnings to medication labels, downgrade a generic drug’s bioequivalence status (meaning it is no longer considered interchangeable with the brand-name drug), or even remove the medication from the market.

While this public, searchable database is useful for keeping track of certain medications, it does not provide a complete or verified picture of a drug’s side effects or safety profile, and individual reports are not independently confirmed. Madris Kinard, who previously worked in post-market safety at the FDA, told STAT that the move was a step in the right direction, but without fuller context on each report, the data may have limited value unless someone is closely monitoring a specific medication.