Misoprostol is a prostaglandin analog that is registered in over 60 countries for treatment and prevention of gastric ulcers caused by prolonged use of anti-inflammatory medications. Because misoprostol causes uterine contractions, it is useful for a variety of obstetric and gynecologic purposes. In recent years, clinicians and researchers have begun building the evidence to support its "off-label" use for a number of reproductive health indications.

Frequently Asked Questions about Misoprostol

What is misoprostol?

What else can misoprostol be used for?

What are the side effects of misoprostol?

Why doesn't the FDA-approved misoprostol product, Cytotec, reflect the drug's use for reproductive health indications?

Why do we still need a dedicated misoprostol product?

Don't see your question here? Let us know.

What is misoprostol?
Misoprostol (brand name Cytotec) is a prostaglandin that has been approved by the FDA for the prevention of gastric ulcers due to use of non-steroidal anti-inflammatory drugs (NSAIDs). Misoprostol is also widely used by obstetricians and gynecologists for the induction of labor, to soften cerix prior to instrumentation, D&C, hysteroscopy, therapeutic abortion, endometrial biopsy, and as a part of the FDA approved mifepristone regimen for the early termination of pregnancy.

What else can misoprostol be used for?
Research and real world experience has demonstrated the utility of misoprostol for a variety of different obstetric and gynecological indications. Given the widespread availability of misoprostol and its low cost, in some settings, misoprostol may present a more feasible treatment option than other more effective, but expensive, drugs like mifepristone. Research to determine safety, effectiveness and optimal regimens for these indications continues. Indications for which misoprostol may be used:

• Cervical ripening before a surgical abortion in the first or second trimester
• Early abortion without mifepristone
• Labor induction in the second trimester
• Treatment of miscarriage or incomplete abortion
• Treatment of postpartum hemorrhage
• Labor induction at term

What are the side effects of misoprostol?
The side effects associated with misoprostol vary according to the dosage and route of administration, but typically include nausea, vomiting, diarrhea, abdominal pain, chills, shivering and fever.

Why doesn’t the FDA-approved misoprostol product, Cytotec, reflect the drug’s use for reproductive health indications?
Cytotec manufacturer, Pfizer, has not studied the use of misoprostol for reproductive health indications and has not applied to the FDA with data to support a new indication on the drug’s label. However, in April 2002, the FDA in conjunction with Pharmacia, removed the contraindication and precaution that Cytotec should not be used in pregnant women. The contraindication for use in pregnancy now refers specifically to the use of the drug for its approved indication — reducing the risk of gastric ulcers induced by NSAIDs. The FDA also created a new "Labor and Delivery" section of the label that acknowledges extensive use of Cytotec for the purposes of cervical ripening and labor induction and provides information about adverse events related to those uses.

Why do we still need a dedicated misoprostol product?
A dedicated product will include FDA-approved dosage and safety information specific to the use of misoprostol use in obstetrics and gynecology for indications such as cervical ripening, labor induction and as a part of the FDA approved regimen for use with mifepristone to induce abortion. As much smaller amounts of drug are needed for the majority of obstetric/gynecological indications than is available in the current pill forms, a dedicated product might allow the marketing of new dosage forms, reducing the risk of over-medication.