Category: Drug Safety Alerts
Pharmacally Medical news Desk
On August 22, 2025, the FDA rolled out daily updates of adverse event data via its FDA Adverse Event Reporting System (FAERS), replacing the slower quarterly updates. It’s part of the agency’s push to modernize the methods of post marketing safety surveillance of drugs and biologics.
FAERS collects reports on side effects, medication errors, and product quality complaints submitted by health professionals, consumers, and manufacturers
This stance of FDA signals their commitment to transparency and quicker detection of safety issues. FDA Commissioner Marty Makary says: “People should not have to wait months for that information to become public.” The goal is to cut that wait and “streamline the process from start to finish”
People can now access the latest adverse event data on the FAERS Public Dashboard at any time. Health professionals and consumers are still encouraged to report any issues via Med Watch.
Important Warnings to Keep in Mind
Reports are not proof of causation: Just because an event is listed doesn’t mean the drug caused it
Data may duplicate or be incomplete: Reports might be submitted by more than one source or lack key information
You can’t use this to estimate how common an event is: FAERS doesn’t track all cases and isn’t built for incidence calculations
It’s not meant to compare the safety of drugs: Differences in reporting rates could simply reflect how widely a drug is used or public awareness
Quick Takeaways
Insight | Why It Matters |
Faster updates | Data is available daily now no more waiting months. |
Clear access | Use the FAERS dashboard for real-time querying. |
Handle with care | Reports are signals and not confirmations. |
Still report issues | Peoples are part of the system use MedWatch if needed. |
By moving FAERS reporting to a daily schedule, the FDA is indicating that post-market safety should be seamless and transparent. While it is advised that data must be interpreted carefully, this change empowers clinicians, researchers, and patients with faster access to safety signals to make more informed decisions.
References
FDA Begins Real-Time Reporting of Adverse Event Data, 22 Aug 2025, US Food and Drug Administration, https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data
FDA Adverse Event Reporting System (FAERS) Public Dashboard, US Food and Drug Administration, https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard
