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Mifepristone Oral tablet

It is used in combination with other medicines to end an early pregnancy (usually during the first 7... more

Generic Name: mifepristone

Brand Names: Mifeprex, Korlym

There is an FDA Alert for this drug. Click here to view it.

  • 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.


FDA approved a REMS for mifepristone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of mifepristone and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

MIFEPRISTONE (mi FE pri stone) is a hormone-like drug. It is used in combination with other medicines to end an early pregnancy (usually during the first 7 weeks). This medicine is only available in a doctor's office, health clinic, or hospital.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • adrenal gland problems
  • bleeding problems
  • cannot easily get emergency medical help in the 2 weeks after you take this medicine
  • cannot return for follow up appointments after you take this medicine
  • have intrauterine device (IUD)
  • it has been more than 49 days (7 weeks) since your last menstrual period began
  • other medical problem
  • porphyria
  • take medicines that treat or prevent blood clots like enoxaparin, warfarin
  • take steroid medicines like prednisone or cortisone
  • tubal or ectopic pregnancy
  • an unusual or allergic reaction to mifepristone, misoprostol, prostaglandins, or other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Before you take this medicine, read the information your doctor or health care provider gives you. Talk to your doctor about any questions you have. Take your medicine exactly as directed. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cerivastatin
  • cisapride
  • dofetilide
  • medicines that treat or prevent blood clots like enoxaparin, warfarin
  • pimozide
  • ranolazine
  • steroid medicines like prednisone or cortisone

This medicine may also interact with the following medications:

  • erythromycin
  • grapefruit juice
  • medicines for fungal infections like ketoconazole, itraconazole
  • medicines for seizures like carbamazepine, phenytoin, phenobarbital
  • medicines used in surgery for anesthesia
  • rifampin
  • St. John's wort or other herbal products

What should I watch for while using this medicine?

For your safety, you must visit your doctor as directed after taking this medicine. Report any unusual effects to your doctor. This medicine can cause birth defects. You will need surgery if this medicine fails to cause a full abortion.

After you take this medicine, some vaginal bleeding is normal. Heavy bleeding may be a sign that something is wrong. If you soak through 2 thick full-size sanitary pads each hour for 2 hours, get medical help right away. Tell the health care provider that you have taken this medicine.

Call your doctor if you have a fever, stomach pain or tenderness, nausea, vomiting, diarrhea, or feel weak. This may be a sign that something is wrong. You may have a serious infection or complication and need medical help.

Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide.

Last Updated: December 01, 2009
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