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.
If you cannot reach your healthcare provider, go to the nearest hospital emergency room. Take the Medication Guide (PDF) 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.
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.
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.
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.
Some women should not take Mifeprex. Do not take Mifeprex if you:
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.
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.
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).
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. Please see additional Important Safety Information and the Medication Guide.
Show moreIf 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.
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.
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.
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.
Some women should not take Mifeprex. Do not take Mifeprex if you:
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.
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.
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).
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By completing and signing the agreement on the next page, you agree that you are executing the agreement electronically, with the same legal effect and validity as a written signature, and you agree to our processing of personal information as described in our Privacy Policy.