Women are not given true informed consent when taking the chemical abortion pill. Policymakers should consider severely restricting the use of mifepristone to protect the safety of pregnant women.

Chemical abortion is the use of the medication mifepristone, typically followed by misoprostol, to end the life of a human fetus and cause the expulsion of the fetus from the uterus.¹ ² The Guttmacher Institute, a non-profit research organization dedicated to advancing abortion in the United States and worldwide, estimates that chemical abortion represented 63 percent of abortions in 2023, up from 53 percent in 2020 and 31 percent in 2014.³ The growth in chemical abortion is likely driving the growth in total abortions in the United States, which increased 11 percent from 2020 to 2023.⁴ Despite the United States Supreme Court’s groundbreaking decision to overturn Roe v. Wade in June of 2022, abortions are increasing as abortion advocates encourage chemical abortion pill use, interstate abortion travel, and the shipping of dangerous abortion pills to circumvent prolife state laws. As the abortion industry-aligned Guttmacher Institute stated in its review of the 2023 abortion data, “Medication abortion has proven to be a game changer in expanding abortion care in the United States.”⁵

The Food and Drug Administration (FDA) and the abortion industry portray the risks of the abortion pill as low. The label acknowledges serious adverse events observed either in clinical trials or in post-approval reported cases, including sepsis, blood transfusion, hospitalization, infection, hemorrhage, uterine rupture, ruptured ectopic pregnancy, and death.⁶ The FDA label for mifepristone acknowledges that about 85 percent of users experience at least one non-serious adverse event including nausea, fever or chills, vomiting, headache, and diarrhea.⁷ However, the FDA’s interpretation of the clinical trial data determined that overall fewer than 0.5 percent of women experienced a “serious adverse event.”⁸ Planned Parenthood reiterates that serious or life-threatening complications are “extremely rare” and claims that the chemical abortion pill is “safer than Tylenol.”⁹

This paper challenges the prevailing narrative that chemical abortion is safe for women. National insurance claims data obtained by the Foundation for the Restoration of America and reviewed by our clinical team of board-certified obstetrician-gynecologists reveals the significant risks of mifepristone to women’s health. Our data shows that chemical abortion poses greater risks to women in real-world clinical use than revealed in the clinical trials of mifepristone and that the rate of serious adverse events from the chemical abortion regimen continues to grow in recent years. The risks of the widespread use of the chemical abortion pill are dire, including a rate of serious adverse events among patients at about 22 times the rate stated on the mifepristone label.

Our dataset of insurance claims¹⁰ for the years 2017 to 2023 identified 692,873 patients who obtained 865,727 chemical abortions (indicating repeat abortions among a significant portion of the dataset). This represents 25% of the chemical abortions that occurred in the US according to Guttmacher Institute’s chemical abortion estimates for the same time period.¹¹ The percentage of abortions that resulted in at least one serious adverse event was 10.9 percent over the seven-year study period.¹²,¹³ The dataset further shows an upward trend in serious adverse event rates in recent years. In 2023 alone, 154,554 chemical abortions occurred with a serious adverse event rate of 11.2 percent.

Based on the dataset, California had the most chemical abortions and the highest rate of chemical abortions in 2023. This state alone made up more than 50 percent of the total 154,554 chemical abortions for the year 2023. The next largest state contributors of chemical abortion nationally were (in order): New York, Illinois, Washington State, New Jersey, Minnesota, Maryland, and Massachusetts.

The states with the lowest rates of identified chemical abortions in 2023 were: Mississippi, Alabama, Arkansas, Oklahoma, Kansas, Kentucky, Tennessee, and Louisiana. This data shows that these states’ pro-life laws have been edective in discouraging the use of any publicly funded insurance resources for abortion, though our team still found instances of women from these states obtaining chemical abortions and billing insurance.

Our findings contradict claims that the chemical abortion pill regimen is safe. The finding from this dataset that more than 1 in 10 women who use mifepristone experience at least one serious health complication within 45 days is in stark contrast to the claims of the FDA and the manufacturer. Our dataset consists of post-market, real-world data which captures outcomes across larger, more diverse populations, over longer periods of time, and in everyday clinical settings. Unlike controlled trials, real-world evidence reflects how mifepristone performs in practice, odering a more accurate and comprehensive view of patient safety.

Our review of insurance claims data for patients who used mifepristone reveals serious dangers posed by the use of the chemical abortion pill regimen. We show that more than 1 in 10 women in the U.S. experience a serious adverse event, about 22 times the rate stated to patients by the FDA. This drastic diderence between the disclosed risk and the actual risk to patients undermines informed consent and endangers the lives of pregnant women. Policymakers and regulatory bodies should review real-world evidence and act decisively to prevent serious harms to women and their health and safety.

The list of adverse event codes was compiled using ICD-10 diagnosis codes and CPT/HCPCS procedure codes from various sources including:

• CDC’s Severe Maternal Morbidity (SMM) list¹⁴

• CMS.gov DRG 770 and DRG769¹⁵

• FAERS¹⁶ mifepristone reported adverse events

• Additional clinician suggested and verified adverse event codes

Adverse events were categorized by FDA definition¹⁷ of Serious or Non-Serious and reviewed by a team of clinicians according to the FDA standard. Only Serious Adverse Events were included for consideration.

Serious Adverse Events were segmented into 2 categories: 1) Serious Adverse Events as reported on the Mifeprex label and 2) Other Serious Adverse Events

1. Serious Adverse Events as reported on the Mifeprex label, which includes those used by the FDA for clinical trials of the medication abortion pill and reported on the Mifeprex (mifepristone) label¹⁸ or in post-market reporting. Categories include Transfusion, Sepsis, ER Visit, Hospitalization Related to Medical Abortion, Infection without Sepsis, and Hemorrhage.

2. Other Serious Adverse Events include those which were not claimed as serious adverse events on the Mifeprex label but required intervention to avoid life threatening events or death. These include ectopic pregnancies or abortion-specific complications and surgeries. In addition, they include life-threatening events studied in the clinical trials but also disclosed on the Mifeprex label, including cardiac, pulmonary, anaphylaxis and thrombosis-related events; ectopic pregnancy complications; subsequent surgical intervention within 45 days of failed medication abortion; birth resulting from a failed abortion; or “other abortion specific complications.”

Multiple Abortion Procedures: Procedures coded as surgical abortions occurring within 45 days of a previous abortion are not counted as a new and separate abortion since the likelihood of repeat pregnancy within that timeframe is infinitesimally small, but instead are categorized as evidence of the adverse event of retained tissue. Surgical abortions within 45 days of a medication abortion are considered Serious Adverse Events because they require intervention to prevent a life-threatening complication such as sepsis from retained tissue. Subsequent administration of misoprostol occurring within 45 days of a previous medication abortion are considered a non-Serious Adverse Event according to FDA definitions.

Subsequent abortions that occurred beyond 45 days are counted as a distinct and separate abortion event.

Study Disclaimer

The presence of a diagnosis or procedure code within the categories analyzed in this study does not establish a clinical diagnosis (e.g., sepsis, hemorrhage, transfusion reaction, infection), nor does it imply causation. Rather, these codes are associated with such conditions and may reflect cases where they were present, considered, or managed. Clinical confirmation and causal inference would require additional patient-level information—such as laboratory results, provider documentation, and treatment details— which are beyond the scope of this analysis.

¹ For an in-depth look at the history of the regulatory regimen surrounding chemical abortion until 2021, including the Food and Drug Administration’s approval process for mifepristone, we recommend the following
source: Israel, Melanie. “Chemical Abortion: A Review.” The Heritage Foundation,
www.heritage.org/life/report/chemical-abortion-review.

² There are other methods of chemical abortion, such as the use of misoprostol only, that are not included in this study. For clarity, only chemical abortions including mifepristone are included.

³ Jones, Rachel, and Amy Friedrich-Karnik. “Medication Abortion Accounted for 63% of All US Abortions in 2023—an Increase from 53% in 2020” Guttmacher Institute, 12 Mar. 2024, www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020.

⁴ United States, Supreme Court. Dobbs v. Jackson Women’s Health Organization. 24 June 2022, www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf.

⁵ Jones, Rachel, and Amy Friedrich-Karnik. “Medication Abortion Accounted for 63% of All US Abortions in 2023—an Increase from 53% in 2020” Guttmacher Institute, 12 Mar. 2024, www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020.

⁶ Mifeprex Label – Accessdata.Fda.Gov, www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s025Lbl.pdf. Accessed 1 Apr. 2025.

⁷ Ibid.

⁸ Ibid., (p.7).

⁹ Is the Abortion Pill Safe? | Read about Abortion Pill Safety, Planned Parenthood, www.plannedparenthood.org/learn/abortion/the-abortion-pill/how-safe-is-the-abortion-pill. Accessed 31
Mar. 2025.

¹⁰ Insurance claims data includes private insurance data, Medicaid, Medicare, and Tricare claims from 2017 to 2023.

¹¹ “Abortion in the United States.” Guttmacher Institute, 15 Apr. 2025, www.guttmacher.org/factsheet/ induced-abortion-united-states.

¹² The Food and Drug Administration (FDA) definition of “serious adverse events” can be found here: Oaice of the Commissioner. “What Is a Serious Adverse Event?” U.S. Food and Drug Administration, 18 May 2023,
www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event.

¹³ We chose to align our definition of serious adverse event with the Food and Drug Administration’s definitions and the Common Terminology Criteria for Adverse Events (CTCAE) in order to provide a close comparison to other studies. A team of clinicians reviewed all flagged events to determine that the serious adverse events identified could be realistically attributed to the use of mifepristone for the purpose of causing a chemical abortion. For more details on our methodology, please see Appendix A.

¹⁴ Maternal Infant Health. Identifying Severe Maternal Morbidity (SMM). 15 May 2024.
https://www.cdc.gov/maternal-infant-health/php/severe-maternal-morbidity/icd.html.

¹⁵ Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRG v37.0 Definitions Manual, 12 September 2019. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0287.html.

¹⁶U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) Public Dashboard, 7 December 2023. https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/fda-adverse-eventreporting-system-faers-public-dashboard.

¹⁷ U.S. Food and Drug Administration. What is a Serious Adverse Event? 18 May 2023.
https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event.

¹⁸ U.S. Food and Drug Administration. Medication Guide Mifeprex. March 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf.