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Medications and More during pregnancy and breastfeeding

Fluconazole (Diflucan®)

Selected References:

  • Aleck KA & Bartley DL. 1997. Multiple malformation syndrome following fluconazole use in pregnancy: report of an additional patient. Am J Med Genet 72:253-6.  
  • Alsaad AM, et al. 2015. Exposure to fluconazole and risk of congenital malformations in the offspring: a systematic review and meta-analysis. Reprod Toxicol 52: 78-82. 
  • Bérard A, et al. 2019. Associations between low- and high-dose oral fluconazole and pregnancy outcomes: 3 nested case-control studies. CMA J 2019;191: E179-E187. 
  • Budani, M. C., et al. 2021.. Maternal use of fluconazole and congenital malformations in the progeny: A meta-analysis of the literature. Reproductive toxicology, 100:42–51.  
  • Diflucan® Drug Label. 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019949s072lbl.pdf. [Accessed 8/2025]. 
  • Carey JC, et al. 2009. Determination of human teratogenicity by the astute clinician method: review of illustrative agents and a proposal of guidelines. Birth Defects Res A Clin Mol Teratol. 85(1):63-8.  
  • Centers for Disease Control and Prevention (CDC). 2021. Vulvovaginal Candidiasis (VVC) STI Treatment Guidelines. Available at: https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm 
  • el-Medany AH, Hagar HH. 2002. Effect of fluconazole on fertility of male rabbits. Arzneimittelforschung. 52:636-40.  
  • Force RW. 1995. Fluconazole concentrations in breast milk. Pediatr Infect Dis J. 14:235-6. 
  • Howley MM, et al, the National Birth Defects Prevention Study. 2016. Fluconazole use and birth defects in the National Birth Defects Prevention Study. Am J Obstet Gynecol 214:657.e1-9. 
  • Inman W, et al. 1994. Safety of fluconazole in the treatment of vaginal candidiasis. A prescription-event monitoring study, with special reference to the outcome of pregnancy. Eur J Clin Pharmacol 46:115-8.  
  • Jick SS. 1999. Pregnancy outcomes after maternal exposure to fluconazole. Pharmacotherapy 19:221-2.  
  • Kaplan YC, et al. 2015. Fluconazole use during breastfeeding. Can Fam Phys. 61:875-6. 
  • Latour M, et al. 2024. Risk of congenital malformations and miscarriages following maternal use of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis. Eur J Epidemiol. 39(12):1325-1340. 
  • Lee BE, et al. 1992. Congenital malformations in an infant born to a woman treated with fluconazole. Pediatr Infect Dis J 11:1062-4.  
  • Liu D, et al. 2020. Fetal outcomes after maternal exposure to oral antifungal agents during pregnancy: A systematic review and meta-analysis. Int J Gynaecol Obstet 148(1): 6-13.  
  • Lopez-Rangel E & Van Allen MI. 2005. Prenatal exposure to fluconazole: an identifiable dysmorphic phenotype. Birth Defects Res A Clin Mol Teratol 73:919-23.  
  • Mastroiacovo P, et al. 1996. Prospective assessment of pregnancy outcomes after first-trimester exposure to fluconazole. Am J Obstet Gynecol 175:1645-50.  
  • Mølgaard-Nielsen D, et al. 2013. Use of oral fluconazole during pregnancy and the risk of birth defects. N Engl J Med 369:830-9.  
  • Mølgaard-Nielsen D, et al. 2016. Association between use of oral fluconazole during pregnancy and risk of spontaneous abortion and still birth. JAMA 315(1):58-67. 
  • Moorhead AM, et al. 2011. A prospective study of fluconazole treatment for breast and nipple thrush. Breastfeed Rev 19:25-9. 
  • Nørgaard M, et al. 2008. Maternal use of fluconazole and risk of congenital malformations: a Danish population-based cohort study. J Antimicrob Chemother 62:172-6.  
  • Pasternak B, et al. 2018. Oral fluconazole in pregnancy and risk of stillbirth and neonatal death. JAMA. 319(22):2333-2335. 
  • Pursley TJ, et al. 1996. Fluconazole-induced congenital anomalies in three infants. Clin Infect Dis 22:336-40.  
  • Sorensen HT, et al. 1999. Risk of malformations and other outcomes in children exposed to fluconazole in utero. Br J Clin Pharmacol. 48(2):234-8.  
  • US Food and Drug Administration (FDA). 2019. FDA Drug Safety Communication: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy. https://www.fda.gov/Drugs/DrugSafety/ucm497482.htm.  
  • Zhang Z, et al. 2019.The safety of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis. BJOG. Aug 24. doi: 10.1111/1471-0528.15913. 
  • Zhu Y, et al. 2020. Oral fluconazole use in the first trimester and risk of congenital malformations: population-based cohort study. BMJ 369: m1494. 

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