Mifepristone, a medication used for medical abortion through 10 weeks of pregnancy, has maintained a strong safety profile over more than two decades of FDA monitoring, according to the agency's latest postmarket review. Since the FDA first approved mifepristone in September 2000, the agency has continuously tracked safety data and found no new safety concerns with the medication when used as directed .

How Does Mifepristone Work for Early Pregnancy Termination?

Mifepristone works by blocking progesterone, a hormone essential for pregnancy to continue. The medication is used in combination with another drug called misoprostol, and the process involves a specific timeline that patients and healthcare providers should understand .

• Day One: A patient takes 200 milligrams of mifepristone by mouth
• 24 to 48 Hours Later: The patient takes 800 micrograms of misoprostol placed in the cheek pouch at a location appropriate for the patient
• Follow-up Care: The patient meets with their healthcare provider about 7 to 14 days after taking mifepristone to confirm the pregnancy has ended

The FDA extended approval for mifepristone from 7 weeks to 10 weeks gestation in 2016, and a generic version became available in April 2019. The generic version is considered therapeutically equivalent to the brand-name product Mifeprex and can be safely substituted .

What Does the Safety Data Actually Show?

The FDA's safety monitoring reveals that serious adverse events associated with mifepristone remain uncommon. As of December 31, 2024, the agency had received 36 reports of deaths in patients associated with mifepristone since the product was approved in September 2000. This includes two cases of ectopic pregnancy, a pregnancy that develops outside the uterus, resulting in death, and several fatal cases of severe systemic infection, also called sepsis .

However, the FDA emphasized that these adverse events cannot be definitively linked to mifepristone alone because patients often used other medications concurrently, received other medical or surgical treatments, had existing medical conditions, or had incomplete health information available for review. The FDA reviewed this safety data and did not identify any new safety signals, meaning the medication's risk profile has not changed .

Who Should Not Use Mifepristone?

While mifepristone is generally safe for eligible patients, certain medical conditions and circumstances make it inappropriate for use. Healthcare providers must screen patients carefully before prescribing the medication .

• Pregnancy Duration: The medication cannot be used if more than 70 days have passed since the first day of the last menstrual period
• Ectopic Pregnancy: Patients with a confirmed or suspected ectopic pregnancy should not use mifepristone, as the medication is designed for intrauterine pregnancies only
• Adrenal Gland Disorders: Patients with problems affecting the adrenal glands, which are located near the kidneys, should not take this medication
• Corticosteroid Use: Those currently receiving long-term corticosteroid therapy are not eligible
• Allergies: Patients with allergic reactions to mifepristone, misoprostol, or similar drugs should avoid the medication
• Bleeding Disorders: Individuals with bleeding problems or those taking anticoagulant medications, commonly called blood thinners, should not use mifepristone
• Rare Genetic Conditions: Patients with inherited porphyria, a rare disorder affecting the liver and other organs, are not candidates
• Intrauterine Devices: Those with an IUD in place must have it removed before taking mifepristone

Understanding these contraindications is critical because they help prevent serious complications. For example, ectopic pregnancies occur in approximately 2 percent of all pregnancies and develop outside the womb, usually in the fallopian tubes. As the fetus grows, the tube cannot accommodate it, potentially causing the tube to rupture and bleed. Unless discovered and treated early, nearly 40 percent of ectopic pregnancies rupture suddenly, causing severe pain and abdominal bleeding, while the remaining 60 percent typically cause slow bleeding in the abdomen. Ruptured ectopic pregnancies can be fatal, which is why mifepristone is contraindicated in these cases .

What Monitoring Does the FDA Require?

The FDA maintains a Risk Evaluation and Mitigation Strategy, or REMS, program for mifepristone to ensure safe use. This program is designed to mitigate the risk of serious complications by requiring specific safeguards beyond the medication's standard labeling. Healthcare providers must follow these protocols and watch for specific signs and symptoms in patients who have taken mifepristone .

The FDA continues to monitor postmarket safety data on mifepristone and its approved generic version. The agency receives reports of adverse events from healthcare providers and patients and reviews this information to determine whether new safety concerns are emerging. As with all approved medications, the FDA takes action when necessary, which could include providing updates to healthcare providers and patients about how to use the drug safely .

The 24-year safety record of mifepristone demonstrates that when used appropriately in eligible patients and with proper medical oversight, the medication remains a safe option for medical termination of early pregnancy. Patients considering this option should discuss their medical history thoroughly with their healthcare provider to ensure they are appropriate candidates and understand the process and what to expect.