When you take a new medication, you trust it’s safe—but safety isn’t just proven in labs. The FAERS database, the FDA’s publicly accessible system for collecting reports of adverse drug reactions. Also known as the FDA Adverse Event Reporting System, it’s the backbone of real-world drug safety monitoring in the U.S. Every year, doctors, pharmacists, patients, and drug companies send in reports about side effects, overdoses, and unexpected reactions. These aren’t lab results—they’re real stories from real people who experienced something harmful after taking a drug.
This system doesn’t just collect data—it connects the dots. If ten people report the same rare heart rhythm issue after taking a new painkiller, the FAERS database flags it. If a generic version of a blood thinner causes more bleeding reports than the brand name, regulators dig deeper. It’s how the FDA found out that certain antibiotics could cause dangerous tendon tears, or that some antidepressants increase suicide risk in teens. The adverse drug reactions, harmful or unintended effects caused by medications tracked here include everything from mild rashes to liver failure and death. And it’s not just about new drugs. Even old medications like statins or NSAIDs show new risks when millions of people use them over time.
The FDA drug monitoring, the ongoing process of tracking medication safety after approval relies on this system because clinical trials can’t catch everything. Trials involve a few thousand people over months. The FAERS database watches millions of people over years. That’s why it’s critical for spotting interactions you won’t find in the package insert—like how a common cough medicine can trigger serotonin syndrome when mixed with an antidepressant, or how a TB drug can make birth control fail. These are the exact kinds of risks covered in posts about dextromethorphan and MAOIs, rifampin interactions, and SSRI-opioid dangers.
What you’ll find in the collection below are real-world examples of how drug safety issues get uncovered—and how they affect you. From counterfeit pills slipping through borders to combination drugs that increase bleeding risk, every article ties back to the same question: How do we know what’s truly safe? The answer starts with the FAERS database. It’s not glamorous. It’s not perfect. But without it, we’d be flying blind.
Learn how to search the FDA's FAERS database for drug side effect reports. Understand what the data shows-and what it doesn't-so you can make smarter decisions about medications.