Skip to Content

Misoprostol Pregnancy and Breastfeeding Warnings

Misoprostol is also known as: Cytotec

Misoprostol Pregnancy Warnings

Misoprostol has been assigned to pregnancy category X by the FDA. Animal studies have failed to reveal evidence of fetotoxicity and teratogenicity. In studies of women undergoing elective first trimester abortion, the administration of misoprostol 400 mcg for two doses caused increased uterine contractions and bleeding in 41% of cases, and partial or complete expulsion of uterine contents in 11% of cases. In addition, frontotemporal congenital malformations in infants born of women who took misoprostol in an attempt to abort pregnancy have been reported. The use of misoprostol during pregnancy is considered contraindicated unless being used as single dose therapy following mifepristone administration for termination of early pregnancy.

Five cases of a congenital malformation, described as an "asymmetrical defect of the cranium and overlying scalp, with exposed dura mater through which the cerebrum can be seen", have been reported. The infants were all delivered of women who took 400 to 600 mcg misoprostol in the first trimester in an attempt to abort the pregnancy. A more recent evaluation of 29 pregnant women who also unsuccessfully used misoprostol in the first trimester in an attempt to abort pregnancy, failed to reveal evidence of teratogenicity. However, the use of misoprostol endangers pregnancy due to its ability to induce uterine contractions, uterine bleeding, and expulsion of uterine contents. Whether or not misoprostol is a human teratogen remains controversial. The Latin American Collaborative Study of Congenital Malformations reports an increased frequency of the following malformations in infants exposed to misoprostol in utero: arthrogryposis, hydrocephalus, holoprosencephaly, transverse limb defects, ring-shaped constrictions of the extremities, and exstrophy of the bladder.

See references

Misoprostol Breastfeeding Warnings

Misoprostol is rapidly metabolized in the mother to misoprostol acid which is biologically active and is excreted in human breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. The manufacturer recommends that caution should be exercised when misoprostol is administered to a nursing woman.

See references

References for pregnancy information

  1. Orioli IM, Castilla EE "Epidemiological assessment of misoprostol teratogenicity." Br J Obstet Gynaecol 107 (2000): 519-23
  2. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  3. "Product Information. Mifeprex (mifepristone)" Danco Laboratories, New York, NY.
  4. Wildeman RA "Focus on misoprostol: review of worldwide safety data." Clin Invest Med 10 (1987): 243-5
  5. Bond GR, Zee AV "Overdosage of misoprostol in pregnancy." Am J Obstet Gynecol 171 (1994): 561-2
  6. Fonseca W, Alencar AJ, Mota FS, Coelho HL "Misoprostol and congenital malformations ." Lancet 338 (1991): 56
  7. "Product Information. Cytotec (misoprostol)." Searle, Skokie, IL.
  8. Castilla EE, Orioli IM "Teratogenicity of misoprostol: data from the Latin-American collaborative study of congenital malformations (ECLAMC)." Am J Med Genet 51 (1994): 161-2
  9. Goldberg AB, Greenberg MB, Darney PD "Misoprostol and pregnancy." N Engl J Med 344 (2001): 38-47
  10. Schuler L, Ashton PW, Sanseverino MT "Teratogenicity of misoprostol ." Lancet 339 (1992): 437

References for breastfeeding information

  1. "Product Information. Cytotec (misoprostol)." Searle, Skokie, IL.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.