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Diflucan and Pregnancy

Based on the results of animal studies and a few reports of problems in humans, Diflucan (fluconazole) may not be safe for pregnant women. There have been reports of multiple, serious birth defects in infants whose mothers took the drug during early pregnancy. If you are taking Diflucan and pregnancy occurs, talk to your healthcare provider.

Is Diflucan Safe While Pregnant?

Diflucan® (fluconazole) is a prescription antifungal medication approved to treat vaginal yeast infections as well as several more serious fungal infections. It is also approved to prevent certain fungal infections in specific situations. Based on the results of animal studies and a few reports of problems in humans, Diflucan may not be safe for use in pregnant women.

Diflucan and Pregnancy Category C or D

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Diflucan is rated as a pregnancy Category C medication when used as a single dose for the treatment of vaginal yeast infections but as a Category D medication for all other uses.
When given to pregnant rats or rabbits, Diflucan caused the following problems:
  • Reduced weight gain in the mother
  • Miscarriages
  • Increased weight of the placenta
  • Birth defects, such as cleft palate and head or face abnormalities.
There have been a few reports of multiple, serious birth defects in infants whose mothers took Diflucan in early pregnancy (usually high doses for an extended period of time). Because the birth defects were distinctive and similar in these cases, it is assumed that the medication probably caused the defects. However, statistics generally do indicate that short-term use (such as the single dose used to treat vaginal yeast infections) does not seem to cause such problems.
A pregnancy Category C or D medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. When treating a vaginal yeast infection, the risks the medication presents to the fetus almost always outweigh the benefits, and a different medication should be chosen. However, for more serious infections, Diflucan may be appropriate during pregnancy.

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‣ Final Thoughts
Last reviewed by: Kristi Monson, PharmD
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