Original data report · FDA + CMS
Drug Safety Data: Key U.S. Statistics
A plain-English snapshot of U.S. medication safety, compiled live from federal records: adverse-event reports, recalls, shortages, interactions, and generic pricing. Every figure links to its source and is free to cite.
- 682
- Medications tracked
- 25,544,484
- FDA adverse-event reports
- 1,179
- Recalls on record
- 35
- Drugs in active shortage
PlainMeds compiles US drug-safety statistics from FDA and CMS data: 25,544,484 adverse-event reports across 682 medications, 1,179 recalls, and 35 active shortages, all free to cite.
These statistics come from public FDA and CMS datasets: FAERS adverse-event reports, FDA drug recalls and shortages, and CMS NADAC pricing. PlainMeds summarizes 25,544,484 adverse-event reports across 682 drugs, 1,179 recalls by class, and 35 active shortages, plus generic-vs-brand savings. Every figure is recomputed from source data and free to cite with attribution. Educational information, not medical advice.
The picture in the data
PlainMeds tracks 25,544,484 FDA adverse-event reports across 524 medications, 1,179 recalls, and 35 active shortages, while a switch to the generic cuts the average drug's price by 85%.
Adverse-event report volume reflects how widely a drug is used and studied, not how dangerous it is. A FAERS report documents a temporal association, never proof of cause.
Adverse-event reporting
The FDA Adverse Event Reporting System (FAERS) is the United States' main post-market drug-safety database. Across the 524 medications PlainMeds summarizes, FAERS holds 25,544,484 reports. Report volume is driven mostly by how many people take a drug and how closely it is studied, so the most widely prescribed medicines naturally sit at the top. Because a single report can name more than one medicine, a report is counted once for each drug it mentions, so this figure reflects report volume across these drugs rather than a count of unique cases. See the most-reported drugs for the full ranking.
Recalls, by severity
Of the 1,179 recall actions on record, most are Class II (a temporary or reversible health risk). Class I recalls, which carry a reasonable probability of serious harm or death, are the smallest group.
Source: FDA Enforcement Reports. See the most-recalled drugs.
Generic pricing
Among the 572 medications with CMS NADAC acquisition-cost pricing, 500 have a generic available, and switching from brand to generic cuts the average drug's per-unit cost by 85%. NADAC reflects what pharmacies pay, not the patient's out-of-pocket price. See drug costs and the most expensive drugs.
Drug interactions
PlainMeds documents 3,919 drug-drug interaction pairs from FDA labeling, of which 268 are flagged major. Check any pair with the interaction checker.
Source: FDA drug labeling. Severity reflects FDA labeling, not a per-patient risk estimate.
Drug shortages
71 medications are in an active FDA-listed shortage, and a further 172 are flagged to be discontinued. Shortages cluster in a few therapeutic classes. See the live drug shortages tracker for current status.
Therapeutic classes with the most drugs in shortage
Source: FDA Drug Shortage Database (current shortages), grouped by PlainMeds drug class.
Download the data
Get the full dataset as a CSV, one row per medication with FDA report counts, interactions, recalls, generic availability and savings, and shortage status. Free to reuse with attribution (CC BY-SA 4.0).
Download CSV (682 medications)Read our methodology for how each figure is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.