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Drugs with Most Adverse Event Reports

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All tracked drugs ranked by total FDA adverse event reports filed through FAERS.

What This Ranking Tells Us

The FDA Adverse Event Reporting System (FAERS) collects reports of adverse drug reactions from healthcare professionals, patients, and manufacturers. A high number of reports does not necessarily mean a drug is dangerous — widely prescribed drugs naturally accumulate more reports. Common over-the-counter medications like aspirin and acetaminophen often appear near the top due to massive usage volumes. Report counts should be interpreted relative to the number of patients taking the drug.

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Primary source: FDA Adverse Event Reporting System (FAERS). Supplementary labeling: FDA Drug Labels (SPL). These rankings are for informational purposes only and should not be used to make medical decisions.

Frequently Asked Questions

What does a FAERS report mean?

A FAERS report documents a suspected adverse event associated with a drug. Reports come from healthcare providers, patients, lawyers, and drug manufacturers. A report does not prove the drug caused the event — it only documents a temporal association. FDA uses patterns across many reports to identify safety signals.

Why do common drugs have the most reports?

Drugs prescribed to millions of patients naturally accumulate more reports even if their individual risk is low. Aspirin, acetaminophen, and other widely used medications appear near the top because of sheer volume. A per-patient reporting rate would be more meaningful but is difficult to calculate from FAERS data alone.

How should I interpret these rankings?

Do not use report counts alone to judge drug safety. A drug with 500,000 reports prescribed to 50 million people may be far safer per-patient than a drug with 5,000 reports prescribed to 10,000 people. Consult your healthcare provider for personalized risk assessment.

Reading the Drugs with Most Adverse Event Reports

This table ranks all tracked drugs by total reports, sourced from FDA Adverse Event Reporting System (FAERS). The dataset is published by the relevant federal agency and updated as new reports and surveys come in. Each row links to a full drug profile so readers can move from headline number to the underlying FDA data — labeling, FAERS reports, recalls, pricing, and shortage status — that explains why a particular drug sits where it does.

The FDA Adverse Event Reporting System (FAERS) collects reports of adverse drug reactions from healthcare professionals, patients, and manufacturers. A high number of reports does not necessarily mean a drug is dangerous — widely prescribed drugs naturally accumulate more reports. Common over-the-counter medications like aspirin and acetaminophen often appear near the top due to massive usage volumes. Report counts should be interpreted relative to the number of patients taking the drug.

Rankings are diagnostic, not prescriptive. Absolute numbers are shaped by exposure volume, reporting practices, and data-collection methodology, so a drug near the top is not automatically "worse" than a drug near the bottom — it may simply be older, more widely prescribed, or manufactured by firms with more visible reporting. Context from FDA Adverse Event Reporting System (FAERS) updates continuously, which means the relative order here can change from one refresh to the next. Rankings on this page are for educational research only and must not be used as a substitute for medical advice from a licensed clinician.

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Data sourced from official U.S. government datasets. See our methodology for details.