Mifepristone, also called “the abortion pill,” is a U.S. FDA-approved oral medication used—along with misoprostol—as part of a two-drug regimen to end a pregnancy up to 70 days into gestation.
Decades of evidence have shown that mifepristone is extremely safe and very effective, says Carolyn Sufrin, MD, PhD, MA, associate professor at the Johns Hopkins School of Medicine and in Health, Behavior and Society at the Bloomberg School.
Yet a lot of misinformation and skepticism exist around the drug’s safety. “Ongoing political discussions portray mifepristone as potentially unsafe, but this could not be further from the truth,” says Suzanne Bell, PhD ’18, MPH, associate professor in Population, Family and Reproductive Health.
The two experts explain the facts around mifepristone, how it works, how we know it’s safe, and why it’s critical to reproductive health.
How Mifepristone Works
Mifepristone blocks the hormone progesterone, which is required to sustain a pregnancy. In the absence of this hormone, a fertilized egg will detach from the uterine wall, and the uterus will contract.
Misoprostol, taken after mifepristone, brings on further contractions, causing the uterus to expel the fertilized egg and other tissue. The two-drug regimen can be used in the comfort and privacy of a person’s own home.
Is Mifepristone Safe?
Currently approved for use in 96 countries, including the U.S., mifepristone was developed in France in the 1980s and approved by the FDA in 2000. Nearly four decades of peer-reviewed research have found it to be safe.
“Mifepristone is one of the most rigorously researched medications—and has been safely and effectively used by millions of pregnant people globally during the last nearly 40 years,” says Bell. Medication abortions accounted for 63% of all U.S. abortions in 2023, according to the Guttmacher Institute, up from 53% in 2020 and 39% in 2017.
The risk of serious complications from a medication abortion is less than 1%, Sufrin says. Only 3%–5% require further intervention to complete the termination.
Childbirth carries significantly greater risks for serious complications than medication and procedural abortion, adds Bell. “A pregnancy ending in birth is 14 times more likely to result in a maternal death than a pregnancy ending in abortion,” Bell adds.
Of the more than 7.5 million people in the U.S. who used the medication between its approval in 2000 and December 31, 2004, 36 deaths associated with mifepristone were reported, per a report from FDA. No deaths have been directly attributed to the drug. A 2023 analysis by CNN found it to be safer than some common drugs like penicillin and Viagra.
Why Is Mifepristone Used With Misoprostol?
When taken together correctly, mifepristone and misoprostol are 93%–99% effective at completing medication abortion, Sufrin says. “Success is defined as passing the pregnancy without need for procedural intervention with a dilation and curettage (D&C) procedure.”
While misoprostol can be used alone to terminate a pregnancy, the success rates and safety are significantly lower than when combined with mifepristone, Sufrin says. Depending on the dosage, the route of administration, and length of gestation, misoprostol’s effectiveness can be around 80%.
Where Mifepristone Is Dispensed
Twenty-eight states currently restrict access to medication abortion; 12 states that restrict access also have total abortion bans.
In other states, mifepristone can be prescribed by certified providers, such as doctors, nurses, or health clinics that meet certain qualifications. Patients can purchase their prescriptions from retail pharmacies that are authorized to dispense mifepristone or have them delivered by mail. Mifepristone cannot be purchased over the counter.
Mifepristone is available in the U.S. under the brand name Mifeprex and as a generic manufactured by GenBioPro or Evita Solutions LLC.
The two-drug regimen, where available, varies in cost, averaging around $600 out-of-pocket. It may be covered by private insurance; federal marketplace and Medicaid plans have other restrictions.
What an FDA Review Could Mean for Mifepristone
In late September, Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced in a letter to 22 Republican attorneys general the agency would be considering modifying the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug, saying “recent studies [are] raising concerns about the safety of mifepristone as currently administered.”
A full ban is unlikely, since the available evidence shows that mifepristone is extremely safe, Sufrin says. “The review should not result in any change in current availability. However, if [the FDA’s] review disregards the decades of safety evidence that we have, the consequences will be profound.”
That means potentially creating new barriers to access, like limiting the drug’s availability through telehealth or by mail, or more stringent restrictions on who is able to prescribe it. Nurses, physicians’ assistants, and doctors currently have that power.
Reduced availability will not change the demand for these medications and will only add stress to an already difficult situation, Sufrin says. “Self-managed abortion with medications is very safe, but people need a way to access these medications.”
Without them, “people might potentially seek unsafe ways to terminate their pregnancies … like resorting to unsafe [medication] suppliers that are not in the U.S.,” she says.
Mifepristone is critical to reproductive health because abortion is critical to reproductive health, Bell says. “Abortion is essential reproductive health care and is fundamental to one’s ability to decide when and whether to have a child or continue a potentially high-risk pregnancy.”