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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?

Has the FDA approved misoprostol for gynecologic indications?

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).[1]  Misoprostol is also widely used by obstetricians and gynecologists for the induction of labor, to soften cervix prior to a medical procedure, D&C, hysteroscopy, therapeutic abortion, endometrial biopsy, and as a part of the FDA-approved mifepristone regimen for the early termination of pregnancy. [2]

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What else can misoprostol be used for?[3]
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 typically low cost, misoprostol may present a more feasible treatment option than other more effective, but expensive, drugs like mifepristone. Research to determine optimal safe and effective regimens for these indications continues:

  • 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

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What are the side effects of misoprostol?[4]
All women who take misoprostol should expect to experience cramping and bleeding, as this indicates that an abortion has taken place.  Additionally, side effects may include nausea, vomiting, diarrhea, abdominal pain, chills, shivering and fever.

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Has the FDA approved misoprostol for gynecologic indications?
At this time, the FDA has approved the misoprostol product, Cytotec, to prevent gastric ulcers.   Cytotec is routinely used off-label in obstetrics and gynecology practice.  It is important to note that in the United States, along with a variety of other countries, drugs can be prescribed and used legally for indications different than their specific “labeled” function.

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[1] National Institute of Health- Medline Plus. (2010). Misoprostol. Retrieved June 8, 2012, from http://www.nlm.nih.gov/medlineplus/druginfo/meds/a689009.html.

[2] UCSF Medical Center. (2012). Medical Abortion. Retrieved June 8, 2012, from http://www.ucsfhealth.org/treatments/medical_abortion/index.html

[3] National Institute of Health- Medline Plus. (2010). Misoprostol. Retrieved June 13, 2012, from http://www.nlm.nih.gov/medlineplus/druginfo/meds/a689009.html.

[4] Planned Parenthood of Central North Carolina. (2009). What to expect when having a medication abortion. Retrieved June 13, 2012, from http://www.plannedparenthood.org/centralnc/files/Central%20North%20Carolina/MAB_Expect_Eng_1-09.pdf

The Best Defense is a Good Offense: Misoprostol, Abortion, and the Law
Conference Summary and Strategic Recommendations

Misoprostol for Abortion Induction in Pregnancies Up to 9 Weeks LMP
Consensus Guidelines

Misoprostol for the Treatment of Incomplete Abortion and Miscarriage
Consensus Guidelines

Gynuity Health Projects
Gynuity Health Projects is a research and technical assistance organization dedicated to the idea that all people should have access to the fruits of medical science and technology development.

Misoprostol: An Emerging Technology for Women's Health [PDF, 565KB]
The report highlights the potential of misoprostol to improve women’s health. The meeting summarized in this report was organized because a large body of scientific work supporting the use of misoprostol for induced abortion, uterine evacuation after pregnancy failure, cervical priming, labor induction, and management of the third stage of labor, had not been synthesized in an accessible way.
Outlook: Misoprostol use in obstetrics and gynecology [PDF, 402KB]
April 2005 publication from PATH on misoprostol use, safety, research, and practice.
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