When you take a new medication, you’re trusting that it’s been thoroughly tested for safety—but what happens after it’s on the market? That’s where FAERS reports, the FDA’s public database of adverse event reports from doctors, patients, and drug makers. Also known as FDA Adverse Event Reporting System, it’s the backbone of post-market drug safety monitoring. These reports don’t prove a drug causes harm, but they flag patterns that might otherwise go unnoticed—like a sudden spike in liver damage linked to a newly approved painkiller, or unexpected heart rhythm issues in patients taking a common antibiotic.
FAERS reports are built from real-world experiences, not clinical trials. That means they capture what happens when thousands of people use a drug under normal conditions, with different ages, health conditions, and other medications. This is where you find the hidden risks: a patient taking an SSRI and tramadol for depression and back pain who ends up in the ER with serotonin syndrome. Or someone on rifampin for tuberculosis who stops birth control because the drug made it ineffective. These aren’t theoretical risks—they’re documented in FAERS by real people, and they’re why the FDA updates warnings, adds black box labels, or even pulls drugs off the market.
What makes FAERS powerful is how it connects to other safety tools. For example, when the FDA issues a REMS program, a risk management plan requiring special training or monitoring for high-risk drugs, it’s often because FAERS data showed too many serious side effects. Or when the agency tightens rules on generic drug approvals, ensuring they match brand-name drugs in safety and effectiveness, they’re using FAERS to check if generics are causing different reaction rates. Even counterfeit drugs, fake medicines that lack active ingredients or contain toxic substances show up in FAERS—when patients report unexpected side effects from pills bought online, investigators trace them back to illegal suppliers.
You won’t find FAERS reports on your prescription label, but they’re the reason those labels exist. If you’ve ever seen a black box warning about serotonin syndrome with SSRIs and opioids, or been told to avoid grapefruit with your statin, that came from FAERS data. It’s not glamorous. It’s not flashy. But without it, we’d be flying blind when drugs turn dangerous after approval.
Below, you’ll find real-world examples of how FAERS reports have shaped medication safety—like how they exposed the dangers of dextromethorphan with MAOIs, why geriatric patients need special caution with polypharmacy, and how FDA inspections catch unsafe imports before they reach pharmacies. These aren’t abstract theories. They’re stories of people who got hurt, reports that were filed, and changes that followed. If you take medication, this is the hidden system watching over you.
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.