When you need to know if a drug is truly safe or why a medication was pulled from shelves, the FDA archive, a public database of approved drugs, safety alerts, and clinical trial data maintained by the U.S. Food and Drug Administration. Also known as Drugs@FDA, it’s the only place where you can see the original approval letters, labeling changes, and adverse event reports that pharmacies and doctors rely on. This isn’t marketing material or blog speculation—it’s the raw, unfiltered record of what the government knows about your medications.
The FDA archive, a public database of approved drugs, safety alerts, and clinical trial data maintained by the U.S. Food and Drug Administration. Also known as Drugs@FDA, it’s the only place where you can see the original approval letters, labeling changes, and adverse event reports that pharmacies and doctors rely on. This isn’t marketing material or blog speculation—it’s the raw, unfiltered record of what the government knows about your medications.
People often confuse the FDA archive with general drug info sites. But the archive doesn’t just list drugs—it shows you adverse drug events, official reports of harmful reactions submitted by patients, doctors, and manufacturers to the FDA, tied to specific drug names and batch numbers. It tracks drug approval records, the complete history of how a medication was tested, reviewed, and authorized for sale in the U.S., including when warnings were added or when a drug was withdrawn. And it’s not just for doctors—anyone can search it to check if a generic version of their pill was approved the same way as the brand name, or if a side effect they’re experiencing shows up in thousands of other reports.
You’ll find real-world data here: how many people reported nausea with Zofran, why Compazine got a black box warning, or when the FDA first flagged neuroleptic malignant syndrome linked to antipsychotics. These aren’t guesses—they’re documented events. If you’ve ever wondered why your doctor switched your blood pressure med from lisinopril to losartan, the FDA archive holds the answer: maybe it was a safety update, a new interaction warning, or a change in approval status. The same goes for EpiPen disposal guidelines, expired patch risks, or why certain anticholinergics can’t be mixed with sleep aids.
The posts below pull directly from this archive. You’ll find step-by-step guides on how to search Drugs@FDA, real examples of side effect reports tied to metformin and SGLT-2 inhibitors, and breakdowns of how the FDA’s decisions on alpelisib or dutasteride changed treatment options. These aren’t opinions—they’re facts pulled from official filings, safety alerts, and approval documents. Whether you’re tracking a rare reaction like Guillain-Barré after a vaccine, comparing antihistamines for your kid, or checking if your generic Lasix is legally approved, the answers start here.
