Mifepristone

What Is Mifepristone

Mifepristone is a prescription drug that blocks progesterone, a hormone a pregnancy needs to continue. Taken with a second drug, misoprostol, it ends an early pregnancy, and the FDA has approved the pair through 70 days, or 10 weeks.

What Taking the Pills Involves

A medication abortion happens at home over a few days, and the FDA label spells out what a patient should expect at each step. The cramping and bleeding are the medicine working, which is why the label tells prescribers to talk with patients about where they will be when they take the second drug.

The FDA-approved regimen, step by step

1. 1 Day 1 Take mifepristone One 200 mg tablet by mouth stops the pregnancy from continuing.
2. 2 24 to 48 hours later Take misoprostol Four tablets held in the cheeks for 30 minutes. Taking them outside that window can make the regimen less effective.
3. 3 Within 2 to 24 hours The pregnancy passes Most patients expel the pregnancy in this window, with cramping and bleeding. It can begin within 2 hours of taking misoprostol.
4. 4 Days to weeks Bleeding tapers Bleeding or spotting lasts 9 to 16 days on average. Heavy bleeding lasts a median of 2 days.
5. 5 Day 7 to 14 Follow-up A follow-up with the provider confirms the pregnancy has ended.

Source: FDA-approved Mifeprex prescribing information, revised January 2023. A description of the label, not medical advice.

The label also tells prescribers to make sure patients know whom to call and what to do if they have a sustained fever, severe abdominal pain, prolonged heavy bleeding, or fainting, or pain or general malaise lasting more than 24 hours after misoprostol. The M+A Hotline above answers medical questions like these.

How Safe Mifepristone Is

Mifepristone ends the pregnancy in about 97 of every 100 cases in U.S. trials, and serious problems are rare. The strongest evidence comes from the drug’s own FDA label, which pools large clinical trials, and from a study that followed California Medicaid patients for six weeks after their abortions.

How these numbers were measured. Both come from the FDA-approved label (FDA label). The 97.4% is from U.S. trials of 16,794 patients through 70 days of pregnancy. The under-0.5% is from ten U.S. and non-U.S. studies of 30,966 patients. The 0.31% comes from a 2015 study of 2009 and 2010 abortions among fee-for-service Medi-Cal patients that counted any hospital admission, surgery, or blood transfusion within six weeks (Obstetrics & Gynecology). The FDA had 32 reports of deaths among those 5.9 million patients through 2022 and says the reported events “cannot with certainty be causally attributed” to the drug (FDA).

That record is the heart of the legal fight, but the lawsuits do not turn on whether the drug works. They turn on how it may be dispensed, and in particular whether it can be prescribed by video and sent by mail.

How People Get Mifepristone Now

The FDA loosened the rules for mifepristone in 2016 and again in 2021, and the lawsuits target those changes (SCOTUSblog). Louisiana’s suit targets the second one. The FDA first required patients to pick up the drug in person at a clinic, medical office, or hospital. It announced the end of that rule in December 2021 and approved the change on January 3, 2023, along with a path for certified retail pharmacies to fill prescriptions (FDA). Prescribers and pharmacies still have to be certified under the drug’s safety program, called the REMS.

Telehealth now reaches more than a quarter of abortion patients, and shield laws carry more than half of those visits.

A shield law protects a doctor in one state who prescribes to a patient in another, usually by refusing to help another state’s investigators or courts. Guttmacher counts 23 states and D.C. with some shield protection for reproductive or gender-affirming care, and eight that extend it to telehealth: California, Colorado, Massachusetts, Maine, New York, Rhode Island, Vermont, and Washington (Guttmacher). #WeCount counted about 14,870 abortions a month provided under shield laws by December 2025 (#WeCount).

The first test of those laws involved a single doctor. Dr. Margaret Carpenter prescribes by telehealth from Ulster County, New York. In February 2025, a Texas judge ordered her to pay more than $100,000 in penalties, after she did not appear in court, in a case accusing her of prescribing pills to a woman near Dallas, and New York Gov. Kathy Hochul refused Louisiana’s request to extradite her on charges of prescribing pills to a pregnant minor. The county clerk refused to file the Texas judgment, Texas Attorney General Ken Paxton sued him, and on October 31, 2025, a New York judge ruled the clerk had followed the shield law (Texas Tribune).

Where the Mifepristone Case Stands

Mifepristone Court Timeline, 2000 to 2026

Mifepristone was approved in 2000, cleared for mail in 2021 and pharmacies in 2023, and survived a Supreme Court challenge in 2024. Louisiana sued in October 2025, the Fifth Circuit restored the in-person rule on May 1, 2026, the Supreme Court paused that order on May 14, and the appeal was argued in September.

1. 2000 FDA approves mifepristone Approved to end early pregnancy with misoprostol.
2. Dec 2021 FDA drops the in-person rule Telehealth prescriptions and mail delivery become possible.
3. Jan 2023 Pharmacies can dispense it Certified retail pharmacies can fill prescriptions.
4. Jun 2024 Supreme Court rejects the first challenge A 9-0 ruling says the doctors who sued lacked standing.
5. Oct 2025 Louisiana sues the FDA Alliance Defending Freedom files for the state.
6. May 1, 2026 Fifth Circuit restores in-person pickup It granted Louisiana's request to reinstate the rule nationwide.
7. May 14, 2026 Supreme Court pauses the order Mail and pharmacy access continue over two dissents.
8. Sep 2026 Fifth Circuit hears the appeal A three-judge panel takes the case under review.

Sources: FDA; Supreme Court; Center for Reproductive Rights; SCOTUSblog; Courthouse News Service.

Mifepristone from approval to the Louisiana case, 2000 to 2026: 2000: FDA approves mifepristone (Approved to end early pregnancy with misoprostol.). Dec 2021: FDA drops the in-person rule (Telehealth prescriptions and mail delivery become possible.). Jan 2023: Pharmacies can dispense it (Certified retail pharmacies can fill prescriptions.). Jun 2024: Supreme Court rejects the first challenge (A 9-0 ruling says the doctors who sued lacked standing.). Oct 2025: Louisiana sues the FDA (Alliance Defending Freedom files for the state.). May 1, 2026: Fifth Circuit restores in-person pickup (It granted Louisiana's request to reinstate the rule nationwide.). May 14, 2026: Supreme Court pauses the order (Mail and pharmacy access continue over two dissents.). Sep 2026: Fifth Circuit hears the appeal (A three-judge panel takes the case under review.).

2000: The FDA approved mifepristone in 2000 to end an early pregnancy in combination with misoprostol.

December 2021: The FDA announced it would drop the requirement that patients pick up the drug in person, which opened the door to telehealth and mail delivery.

January 2023: The FDA approved the change on January 3, 2023, and let certified retail pharmacies dispense the drug.

June 2024: In FDA v. Alliance for Hippocratic Medicine, the Supreme Court ruled unanimously on June 13, 2024, that the doctors and groups who sued lacked standing (Supreme Court). It did not decide whether the FDA’s rules were lawful.

October 2025: Louisiana sued the FDA on October 6, 2025, represented by Alliance Defending Freedom.

May 1, 2026: The Fifth Circuit granted Louisiana’s request to reinstate the in-person rule nationwide while its appeal was pending, finding the state likely to win its challenge (Center for Reproductive Rights).

May 14, 2026: The Supreme Court stayed the Fifth Circuit’s order at the request of the drug’s two makers, Danco and GenBioPro. Justice Thomas argued in dissent that the 1873 Comstock Act makes mailing the drug a crime.

September 2026: A Fifth Circuit panel of Judges Stephen Higginson, Priscilla Richman, and Dana Douglas heard Louisiana’s appeal on September 9.

October 7, 2026: The FDA told the Louisiana trial court it expects to finish its safety study report by March 2027 and will decide after that whether the rules need to change (FDA status report).

Where the Disagreement Lies

The disagreement in court is mostly about how mifepristone should be dispensed, not whether it works.

Louisiana, represented by Alliance Defending Freedom, argues that the FDA’s decision to drop the in-person requirement was not backed by appropriate data and that pills mailed into the state are used to get around its abortion ban. At the September 9 argument, Louisiana’s solicitor general said, “There’s no dispute that Louisiana’s experiencing 1,000 abortions a month due to mifepristone mailed into the state.” Judge Priscilla Richman questioned the link, saying she had trouble finding “anywhere in the record that the FDA has approved the mailing of this drug into states where it’s unlawful to do that” (Courthouse News).

The drug’s makers, Danco and GenBioPro, argue that Louisiana lacks standing, as the doctors in the 2024 case did, and that pausing the order keeps the long-standing rules in place while the FDA finishes its review (SCOTUSblog). The FDA’s own label reports serious reactions in under 0.5% of patients in clinical trials.

The FDA’s review sits between the two positions. It could keep the current rules, restore the in-person visit, or add new requirements. It has not set a date for that decision, but it told the court in October that it expects its safety study report by March 2027.

Frequently Asked Questions

Is mifepristone still legal? Yes, under federal rules, as of October 6, 2026. The Supreme Court kept mail and pharmacy access in place while Louisiana’s appeal continues. States that ban abortion make providing it a crime under state law.

What happens if the Fifth Circuit rules for Louisiana? A ruling for Louisiana could restore the in-person rule, and the drug’s makers could again ask the Supreme Court to step in, as they did in May. Access would depend on what the justices do next.

What is the difference between mifepristone and misoprostol? Mifepristone blocks progesterone and stops the pregnancy from continuing. Misoprostol, taken 24 to 48 hours later, makes the uterus cramp and empty.

Can I be prosecuted for taking abortion pills? It depends on your state and your situation, and the law is changing. The Repro Legal Helpline (844-868-2812) gives free, confidential answers.

What You Can Do

1. If you need medication abortion now, start with verified sources. AbortionFinder.org lists providers by state, including telehealth. The M+A Hotline answers medical questions, and the Repro Legal Helpline answers legal ones.
2. If your state has a shield law, ask legislators to protect it. Eight states extend theirs to telehealth, so ask your state legislators, whom you can find at Open States, to keep those protections in place.
3. If your state has no shield law, ask for one. Guttmacher’s shield law tracker shows what neighboring states have passed.
4. Watch the FDA’s review. The FDA told the court on October 7, 2026 that it expects its safety study report by March 2027 and will update its timeline then. Any rule change would appear in the Federal Register.
5. Ask Congress to go on record against restoring the in-person rule. Use the letter and call script below.