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.

Data updated 2026-05-15

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, Class II leads by count (997, 85%). Class I is the most serious FDA tier (103 actions), not the rarest. Class III has the fewest (79).

Class I (most serious) 103 (9%)
Class II 997 (85%)
Class III (least serious) 79 (7%)

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.

Major 268 (7%)
Moderate / Minor 3,651 (93%)

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

Opioid Analgesic 4
Corticosteroid 3
CNS Stimulant 3
Benzodiazepine 3
Loop Diuretic 2
Vasopressin Analog 1

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)

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. National tallies on this page are aggregated live from the same FDA and CMS extracts used on drug pages. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

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.