Is Mifepristone Safe?


Although it’s been prescribed for over two decades, mifepristone, or Mifeprex, is still steeped in controversy.

The nicknamed “abortion pill” mifepristone is often the focal point of many abortion ban discussions and political hearings. A 2023 lower court ruling to ban pandemic-era mail-order deliveries and telemedicine prescriptions of the drug, as well as limit its use from a typical 10 weeks to seven weeks, was put on hold in April 2024. A high court decision is expected in June 2024.

Aside from ongoing legal implications, here’s what you should know about the safety of taking mifepristone and how you can access the medication if you need it.

What Is Mifepristone?

Mifepristone is a medication that blocks progesterone, an essential hormone for a developing pregnancy. During a healthy pregnancy, progesterone thickens the uterine lining, aiding egg implantation.

Medical professionals prescribe mifepristone for two primary reasons during pregnancy:

To induce first-trimester abortion. Mifepristone is often used in conjunction with another medication called misoprostol, or Cytotec. “Mifepristone blocks the hormonal support for the pregnancy, and then misoprostol then helps the uterus expel the pregnancy,” explains Dr. Tessa Madden, a professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine. She is also a Yale Medicine OB-GYN and complex family planning specialist in New Haven, Connecticut. Misoprostol does this by increasing hormone-like substances called prostaglandins. Prostaglandins induce uterine contractions and soften the cervix. Both of these actions lead to easier passage of fetal tissue through the cervix and vagina.

To medically manage miscarriage. After confirming a miscarriage through a blood test or an ultrasound, you have some options for how to manage the miscarriage. Many people opt for mifepristone and misoprostol to pass fetal remains because it avoids surgery, like dilation and curettage, and it can be done in the comfort and privacy of your own home. This method is typically not recommended for pregnancies over 11 weeks, says Dr. Jessica Lee, an OB-GYN at the University of Maryland Medical Center and assistant professor at the University of Maryland School of Medicine in Baltimore. It also varies based on individual circumstances, like personal preferences or health conditions.

Whether you use mifepristone to terminate a pregnancy or to medically manage miscarriage, it works in the same manner.

[Early Signs of Pregnancy: Symptoms to Watch For]

Mifepristone regimen

To terminate a pregnancy up to 10 weeks gestation, the approved regimen is as follows, according to the Food and Drug Administration:

Day 1. On the first day, you’ll take 200 milligrams of mifepristone orally.

Days 2-3. One to two days after the initial dose, you’ll take 800 micrograms of misoprostol. The medication is taken by placing it in the cheek pouch and allowing it to absorb (buccally).

Days 7-14. One to two weeks after taking the medication, you’ll follow up with your health care provider. If you have concerns or side effects prior to then, you may follow up immediately.

[READ: What Is an Ectopic Pregnancy and Symptoms to Watch For]

Is Mifepristone Safe?

There is a substantial body of evidence supporting the safety and efficacy of both mifepristone and misoprostol.

“This is more data than we have for some other medications commonly used in health care,” Madden explains.

Some of this data includes:

FDA safety data. The FDA conducts periodic reviews for Mifeprex, the brand name of the drug, and the administration has not identified safety concerns for using the medication up to 70 days of gestation.

The American College of Obstetricians and Gynecologists safety data. Madden adds that ACOG data demonstrates the combination of mifepristone and misoprostol is very effective, with a failure rate as little as 0.3% to 3.4% depending on gestational duration. “The risk of complication is low, much less than 1%,” she adds.

Independent studies. Multiple studies show that mifepristone and misoprostol can be provided safely via telehealth appointments.

[READ: Pregnancy and Body Image in a Post-Roe World]

Is Mifepristone FDA-approved?

The FDA approved Mifeprex, the brand name for mifepristone, over two decades ago. Since, there have been extensive studies to support its safety and efficacy.

“Mifepristone and misoprostol are widely used, accounting for 63% of all abortions in 2023,” Madden says.

According to its post-market safety information, the FDA claims Mifeprex is approved based on a “thorough and comprehensive review of the scientific evidence presented that determined that it was safe and effective for its indicated use.”

The FDA has additionally instituted a Risk Evaluation and Mitigation Strategy program to reduce potential complications from mifepristone.

This includes precautions like:

— Ensuring the medication is prescribed by a qualified health care provider, certified under the REMS program.

— Requiring patients to sign a patient agreement form after reviewing the risks of mifepristone treatment with their health care provider.

— Enforcing that pharmacies complete a pharmacy agreement form and agree to dispense the medication in a timely manner.

Mifepristone Side Effects

The most common side effect of mifepristone is light bleeding or spotting. The bleeding occurs due to the expulsion of pregnancy tissues, and temporary alterations to the cervix and uterine lining.

Dr. Kelly Culwell, a board-certified OB-GYN and complex family planning specialist based in San Diego, says, “Some people will have spotting or bleeding after taking mifepristone, but there is usually no spotting or bleeding until you take the second set of pills for medication abortion, which is the misoprostol.”

Lee adds, “In cases where a single-drug protocol is used, just misoprostol, there is a 15% failure rate, which would potentially necessitate re-administration of the drug or a surgical procedure.”

In some cases, other side effects may include:

— Chills.

— Dizziness.


— Severe cramping.

— Heavy bleeding.


— Allergic reaction.

— Severe pain.

These side effects are rare, and if they do occur, you should contact your health care provider immediately for medical attention.

Where to Get Mifepristone

You have a few options to get mifepristone. Some of these include:

— An in-person clinic visit.

— A telehealth appointment.

— A Planned Parenthood center.

— Retail pharmacies in certain states.

“Access is such an important factor. It isn’t practical or compassionate to expect anyone to drive a long distance while experiencing a miscarriage or medical abortion,” Lee says.

Given mifepristone’s safety profile and importance to health care, access should not be hindered, Lee adds.

Is Mifepristone Legal in All States?

In states where abortion care is available, mifepristone is available, Culwell says.

“The medication is not illegal, even in states where abortion is legally restricted,” she explains. “Prescribing the medication for abortion might be illegal, but the medication is still FDA approved and can be provided via telehealth by providers in states where abortion is not restricted.”

This is because many states have “shield laws,” which serve to protect medical providers when they prescribe medications to individuals in other states.

To learn more about the laws in your state, where to get mifepristone and if you have any legal risk to self-managing an abortion at home, visit the following resources:

Mayday Health.

Plan C.

Abortion Finder.

These sites will help you determine if medical abortion with mifepristone and misoprostol is safe for you by asking screening questions.

“State laws vary regarding whether someone who takes medication abortion pills can be prosecuted, but these websites can provide guidance on this as well as how to stay safe,” Culwell explains.

There are current cases moving through the court challenging the FDA’s approval of mifepristone and recent changes to the requirements for how mifepristone is provided, including a case that will be decided by the Supreme Court later this summer.

The Bottom Line

Mifepristone is a medication commonly used for medical abortion and miscarriage management. It has a low complication rate, supported by its FDA data, ongoing safety data and ACOG recommendations. Mifepristone is the drug of choice for nearly two-thirds of the abortions conducted in the United States.

Despite ongoing legal battles and regulatory changes surrounding mifepristone, mifepristone remains safe and effective. You can learn more about access to mifepristone by talking to your health care provider or visiting resources like Mayday Health, Plan C, or Abortion Finder.

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