New Analysis Suggests Adverse Drug Events Are the 3rd Leading Cause of Death in the USA

According to an analysis conducted by the American Society of Pharmacovigilance (ASP), adverse drug events (ADEs) are now the third leading cause of death in the United States. This figure combines ADEs that result from several causes including prescribing errors, prescription drug overdoses, prescription drug misuse, drug-drug interactions, allergic reactions, and adverse drug reactions (ADRs). The ASP launched the “Third Cause Campaign” in response to the new data, estimating that ADEs account for ~250,000 deaths each year, a greater number than deaths caused by stroke and respiratory disease. These findings were announced in conjunction with National Adverse Drug Event Awareness Day, March 24, 2025.

The summary of the analysis, published on the ASP website, explains that it is difficult to estimate the number of deaths related to ADEs due to underreporting in databases like the Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) and ambiguity regarding death certificates. The ASP states that, when accounting for all causes of fatal ADEs based on hospital records and epidemiologic studies, including overdoses, fatal medication errors, and drug-induced anaphylaxis, an estimated 250,000 to 300,000 deaths in the US each year may be attributable to ADEs.

In response to these data, the ASP initiated the Third Cause National Action Plan consisting of the following:

• The establishment of a national medication safety task force
• The launch of expanded pharmacovigilance and medication safety training
• The advancement of pharmacogenomic and precision medicine
• The mobilization of the public and patient empowerment through social media

"Adverse drug events are a leading cause of death in this country," said Congressman Eric Swalwell, Co-Founder of the Personalized Medicine Caucus. "By factoring genetic testing results into medical prescription decisions, we can have the knowledge to better treat a range of conditions while reducing adverse drug events. PGx [pharmacogenomics] will help medical professionals and patients be well informed to decide effective treatments for each clinical case."