Consumer Safety Information | Mifeprex (mifepristone)

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

What symptoms should I be concerned with?

Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of Mifeprex and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your healthcare provider.

Be sure to contact your healthcare provider promptly if you have any of the following:

Heavy 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. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C).
Abdominal Pain or “Feeling Sick.” If you have abdominal pain or discomfort, or you are “feeling sick,” including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your healthcare provider without delay. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb).
Fever. In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your healthcare provider right away. Fever may be a symptom of a serious infection or another problem.

If you cannot reach your healthcare provider, go to the nearest hospital emergency room.

What to do if you are still pregnant after Mifeprex with misoprostol treatment. If you are still pregnant, your healthcare provider will talk with you about a surgical procedure to end your pregnancy. In many cases, this surgical procedure can be done in the office/clinic. The chance of birth defects if the pregnancy is not ended is unknown.

Talk with your healthcare provider.

Before you take Mifeprex, you should read the Medication Guide (PDF) and you and your healthcare provider should discuss the benefits and risks of your using Mifeprex.

What is Mifeprex?

Mifeprex is used in a regimen with another prescription medicine called misoprostol, to end an early pregnancy. Early pregnancy means it is 70 days (10 weeks) or less since your last menstrual period began. Mifeprex is not approved for ending pregnancies that are further along. Mifeprex blocks a hormone needed for your pregnancy to continue.

When you use Mifeprex on Day 1, you also need to take another medication called misoprostol 24 to 48 hours after you take Mifeprex, to cause the pregnancy to be passed from your uterus.

The pregnancy is likely to be passed from your uterus within 2 to 24 hours after taking Mifeprex and misoprostol. When the pregnancy is passed from the uterus, you will have bleeding and cramping that will likely be heavier than your usual period. About 2 to 7 out of 100 women taking Mifeprex will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.

Who should not take Mifeprex?

Some women should not take Mifeprex. Do not take Mifeprex if you:

Have a pregnancy that is more than 70 days (10 weeks).
Are using an IUD (intrauterine device or system) (must be taken out before you take Mifeprex).
Have been told by your healthcare provider you have a pregnancy outside the uterus (ectopic pregnancy).
Have problems with your adrenal glands.
Take medicine to thin your blood.
Have a bleeding problem.
Have porphyria.
Take certain steroid medicines.
Are allergic to mifepristone, misoprostol or other prostaglandins.

Mifeprex cannot be used in cases of confirmed or suspected ectopic pregnancy as MIFEPREX is not effective for terminating those pregnancies. If you are using an IUD, it must be taken out before you take Mifeprex.

What are the possible side effects of Mifeprex and misoprostol?

Mifeprex may cause serious side effects. See “What is the most important information I should know about Mifeprex?” above.

Cramping and Bleeding. Cramping and vaginal bleeding are expected with this treatment. Usually, these symptoms mean that the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must follow-up with your healthcare provider approximately 7 to 14 days after taking Mifeprex. See “How should I take Mifeprex?” in the Medication Guide (PDF) (link to Medication Guide) for more information on your follow-up assessment. If you are not already bleeding after taking Mifeprex, you probably will begin to bleed once you take misoprostol, the medicine you take 24 to 48 hours after Mifeprex. Bleeding or spotting can be expected for an average of 9 to16 days and may last for up to 30 days. Your bleeding may be similar to, or greater than, a normal heavy period. You may see blood clots and tissue. This is an expected part of passing the pregnancy.

The most common side effects of Mifeprex treatment include: nausea, weakness, fever/chills, vomiting, headache, diarrhea and dizziness. Your provider will tell you how to manage any pain or other side effects. These are not all the possible side effects of Mifeprex.

Call your healthcare provider for medical advice about any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088.

General Information about the safe and effective use of Mifeprex.

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide(PDF). The Medication Guide summarizes the most important information about Mifeprex. If you would like more information, talk with your healthcare provider. If you would like information about Mifeprex that is written for healthcare professionals you may download the Prescribing Information(PDF).

Important Safety Information

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

What symptoms should I be concerned with?

Be sure to contact your healthcare provider promptly if you have any of the following:

Heavy 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. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical aspiration or D&C).
Abdominal Pain or “Feeling Sick.” If you have abdominal pain or discomfort, or you are “feeling sick,” including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your healthcare provider without delay. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb).
Fever. In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your healthcare provider right away. Fever may be a symptom of a serious infection or another problem.

If you cannot reach your healthcare provider, go to the nearest hospital emergency room. Take the Medication Guide (PDF)(link to Medication Guide) with you. When you visit an emergency room or a healthcare provider who did not give you your Mifeprex, you should give them your Medication Guide so that they understand that you are having a medical abortion with Mifeprex.

Talk with your healthcare provider.

Before you take Mifeprex, you should read the Medication Guide (PDF) and you and your healthcare provider should discuss the benefits and risks of your using Mifeprex.

What is Mifeprex?

When you use Mifeprex on Day 1, you also need to take another medication called misoprostol 24 to 48 hours after you take Mifeprex, to cause the pregnancy to be passed from your uterus.

Who should not take Mifeprex?

Some women should not take Mifeprex. Do not take Mifeprex if you:

Have a pregnancy that is more than 70 days (10 weeks).
Are using an IUD (intrauterine device or system) (must be taken out before you take Mifeprex).
Have been told by your healthcare provider you have a pregnancy outside the uterus (ectopic pregnancy).
Have problems with your adrenal glands.
Take medicine to thin your blood.
Have a bleeding problem.
Have porphyria.
Take certain steroid medicines.
Are allergic to mifepristone, misoprostol or other prostaglandins.

What are the possible side effects of Mifeprex and misoprostol?

Mifeprex may cause serious side effects. See “What is the most important information I should know about Mifeprex?” above.

Call your healthcare provider for medical advice about any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088.

General Information about the safe and effective use of Mifeprex.

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide (PDF). The Medication Guide summarizes the most important information about Mifeprex. If you would like more information, talk with your healthcare provider. If you would like information about Mifeprex that is written for healthcare professionals you may download the Mifeprex Prescribing Information (PDF).