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mifepristone (cont.)

What should I discuss with my healthcare provider before taking mifepristone (Mifeprex)?

Do not take mifepristone if

  • it has been more than 49 days (7 weeks) since your last menstrual period began;
  • you have an IUD;
  • your healthcare provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy);
  • you have problems with your adrenal glands (chronic adrenal failure);
  • you take a medicine such as warfarin (Coumadin) to thin your blood;
  • you have a bleeding problem;
  • you take certain steroid medicines:
  • you cannot return for the next 2 visits;
  • you cannot easily get emergency medical help in the 2 weeks after you take mifepristone; or
  • you are allergic to medicines that contain misoprostol, such as Cytotec or Arthrotec.

Before taking mifepristone, tell your healthcare provider about any other medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to take mifepristone, or you may require special monitoring during treatment.

Mifepristone is in the FDA pregnancy category X. This means that mifepristone is known to cause birth defects in an unborn baby. Mifepristone treatment that does not end in termination of pregnancy may cause birth defects in the unborn baby.

It is not known whether mifepristone passes into breast milk. Do not take mifepristone without first talking to your doctor if you are breast-feeding a baby.

How should I take mifepristone (Mifeprex)?

Take mifepristone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

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.

On Day 1 at your healthcare provider's office, you will read the Medication Guide for mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets of mifepristone.

When you return to your healthcare provider's office on Day 3, your healthcare provider will check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms.

About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare provider's office to be sure you are well and that you are not pregnant. Your healthcare provider will check to see whether the pregnancy has completely ended. 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.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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