FDA Adverse Event Report Statistics

Reports per year

Adverse event reports submitted to the FDA rose steadily from about 205,064 in 2004 to a peak of roughly 1.57 million in 2021, then eased to about 1.31 million in 2025, the most recent complete year. These are counts of reports received, which reflect reporting activity and program changes, not confirmed changes in drug safety. Figures for 2026 are partial, through March 31, 2026.

Most-reported reactions

Across all medications, the reactions reported most often to the FDA are broad symptoms and reporting terms like drug ineffective, nausea, and fatigue. A reaction appearing here means it was named in a report alongside a medication, not that the medication was confirmed to cause it.

Death appears in this table as a reported outcome term (837,474 reports). Separately, 1,859,588 reports carry a death seriousness flag. These are recorded differently and should not be summed or treated as the same figure.

Reported outcomes

When a report is marked serious, it can also be flagged for specific outcomes. Each flag describes what a report noted, not a confirmed effect of any medication. Reports can carry more than one flag.

• About 1,859,588 reports (9.1 percent of all reports) were flagged as involving a death, meaning a death was noted in the report, not that a medication was confirmed to have caused it.
• About 4,346,326 reports (21.4 percent of all reports) were flagged as involving hospitalization.
• About 565,962 reports (2.8 percent of all reports) were flagged as life-threatening.
• Overall, about 57.5 percent of reports were classified as serious and 42.5 percent as non-serious, a classification of the report, not a confirmed outcome of the medication.

Reports by sex

Where the patient's sex was recorded (about 87.4 percent of all reports), women accounted for 60.3 percent of FDA adverse event reports and men 39.7 percent. Sex was not specified in the remaining reports, so these shares describe reports with a recorded sex, not all reports.

Women 60.3% (10,722,518)  |  Men 39.7% (7,054,595)

Reports by reporter type

Nearly half of FDA adverse event reports (about 47.3 percent of those with a reporter type recorded) came from consumers rather than health professionals, a sign that these are voluntary reports from many sources, not verified clinical determinations.

Most-reported medications

Report volume reflects how widely a medication is used and how actively reports are collected, not how risky it is. Adalimumab (Humira) tops this list largely because biologics manufacturers run patient-support programs that actively gather and submit reports, not because it is the most dangerous medication in America. Widely used over-the-counter products and supplements reported to the FDA, such as aspirin, acetaminophen, and vitamin D (ergocalciferol), also appear here, which further shows that this list tracks usage and reporting, not risk.

About this data

These statistics cover the entire FDA Adverse Event Monitoring System (AEMS), compiled by PillSignal directly from openFDA's public aggregate data. They are not limited to the medications with pages on PillSignal.

All figures are counts of reports. Because reporting is voluntary and a single report can name several medications and several reactions, these numbers describe reporting activity and cannot be read as rates of harm or as confirmed effects of any medication.

In the most-reported medications list, dose and formulation variants of the same medication are combined under one name, and each medication's count reflects its single most-reported variant. True molecule-level totals, adding every brand and formulation together, would be higher, so the figures shown are conservative undercounts.

We do not show an age breakdown. Patient age group is recorded on only about 18 percent of reports, too few to represent the database fairly.

Data is drawn from openFDA and runs through March 31, 2026. This page updates automatically when PillSignal refreshes its data. Last updated June 2026.

How to cite this page