The Abortion Pill Harms Women:Insurance Data Reveals One in Ten PatientsExperiences a Serious Adverse Event

Policy Papers
Written By Caleb Slagle

Jamie Bryan Hall, Director of Data Analysis, Ethics and Public Policy Center

Ryan T. Anderson, President, Ethics and Public Policy Center

April 28, 2025

Summary

  • This largest-known study of the abortion pill is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.

  • 10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.

  • The real-world rate of serious adverse events following mifepristone abortions is at least 22 times as high as the summary figure of “less than 0.5 percent” in clinical trials reported on the drug label.

  • The FDA should immediately reinstate its earlier, stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects.

  • The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether.

Danco Laboratories markets Mifeprex as “the safe and effective abortion pill,” but our research shows that mifepristone abortion, as currently practiced in the U.S., is not safe and effective.1 The manufacturer and the FDA rely on the results of 10 clinical trials with a total of 30,966 participants, less than 0.5 percent of whom reportedly experienced serious adverse reactions. In contrast, we analyzed real-world insurance claims data for 865,727 prescribed mifepristone abortions, broadly representative of women who obtain mifepristone abor-tions in the U.S. today, and we find a serious adverse event rate of 10.93 percent—at least 22 times as high as the summary figure reported on the drug label. In light of this research, we urge the FDA to reinstate earlier, stronger patient safety protocols and reconsider its approval of mifepristone altogether. Women deserve better than the abortion pill.

Caleb Slagle