# How the FDA reviews drug safety signals

> Overview of how the FDA monitors post-market drug safety through FAERS, Sentinel, and other surveillance systems.

**Canonical URL:** https://drugsmonitor.com/guides/inside-the-fda-safety-review-process
**Last updated:** 2026-06-11

After a drug is approved, the FDA continues to monitor its safety through multiple systems. The FDA Adverse Event Reporting System (FAERS) collects spontaneous reports from patients, providers, and manufacturers. The Sentinel System proactively analyzes electronic health data from millions of patients.

When a safety signal is detected, the FDA may require label changes, issue a Drug Safety Communication, require additional studies, or in rare cases request a market withdrawal. These actions are documented on the FDA's website and are publicly accessible.

Understanding the FDA's post-market safety framework helps patients make informed decisions about their medications. Our FAERS and MedWatch guide white paper explains how to interpret adverse event data and what to do if you experience a side effect.

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*Educational guide from DrugsMonitor.com. Not legal advice.*