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Drug Notebook

Generic Name: mifepristone

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Mifeprex
A hormone - used to induce Abortion
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FDA Alerts

  • Risk of serious bacterial (e.g., Clostridium sordellii) infection and sepsis, which can present without fever, bacteremia, or significant findings on pelvic examination. Deaths reported very rarely in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. (See Infection and Sepsis under Cautions and see Advice to Patients.)
  • Prolonged heavy vaginal bleeding may be a sign of incomplete abortion or other complications; may require prompt medical or surgical intervention. (See Hemorrhage under Cautions and see Advice to Patients.)
  • Discuss medication guide and patient agreement with patients. Ensure that patients know whom to call and what to do in an emergency. If patients visit an emergency room or clinician other than the original prescriber, advise patients to present medication guide to alert clinician of recent medical abortion.

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What is the most important information I should know about mifepristone?

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What is mifepristone?

Mifepristone blocks the actions of the naturally occurring hormone progesterone, which is necessary for pregnancy to continue.

When used together with another medicine called misoprostol, mifepristone is used to end an early pregnancy.

Mifepristone may also be used for purposes other than those listed in this medication guide.

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