Fluconazole Pregnancy Category and Safety
Oral fluconazole is contraindicated during pregnancy for vulvovaginal candidiasis; use topical azole antifungals for 7 days instead. 1
Pregnancy Category Classification
Fluconazole does not have a traditional FDA pregnancy category letter grade under the current labeling system, but it carries significant teratogenic warnings. High-dose fluconazole (≥400 mg/day) is associated with a distinct pattern of congenital anomalies known as "fluconazole embryopathy," including craniosynostosis, characteristic facial dysmorphisms, digital synostosis, and limb contractures. 1, 2
Critical Safety Distinction: Dose-Dependent Risk
Low-dose fluconazole (150 mg single dose) for vulvovaginal candidiasis is associated with increased risk of spontaneous abortion (OR 1.99) and cardiac malformations, including septal defects (OR 1.3) and tetralogy of Fallot (OR 3.39). 3
High-dose fluconazole (≥400 mg/day) carries substantially higher teratogenic risk and is absolutely contraindicated. 1, 2
Even though lower doses appear "safer" in some studies, the CDC and ACOG explicitly recommend against oral fluconazole at any dose during pregnancy. 1
Recommended Treatment Algorithm for Pregnant Women
First-line therapy: Choose one topical azole regimen for 7 days minimum 1:
- Clotrimazole 1% cream 5g intravaginally for 7-14 days 1
- Clotrimazole 100mg vaginal tablet once daily for 7 days 1
- Miconazole 2% cream 5g intravaginally for 7 days 1
- Terconazole 0.4% cream 5g intravaginally for 7 days 1
Treatment efficacy: Topical azoles achieve 80-90% cure rates with symptom relief and negative cultures. 1
Special Clinical Scenarios
For severe vulvovaginitis: Extend topical azole therapy to 7-14 days rather than switching to oral agents. 1
For recurrent vulvovaginal candidiasis during pregnancy: Use topical imidazoles (such as clotrimazole) for suppressive therapy; systemic azoles remain contraindicated. 2
If treatment fails: Consider non-albicans Candida species (particularly C. glabrata), which may require alternative topical regimens or longer duration, not oral therapy. 1
Critical Pitfall to Avoid
The most common error is prescribing the standard non-pregnant regimen (fluconazole 150mg single dose) to pregnant women. This must be avoided entirely. 1 If a woman becomes pregnant while on fluconazole suppressive therapy, discontinue the medication immediately. 2
Partner Treatment
Routine treatment of sexual partners is not indicated, as vulvovaginal candidiasis is not sexually transmitted. Treat partners only if they have symptomatic balanitis, using topical antifungals. 1
Key Contraindication Summary
Oral fluconazole should NOT be used at any dose during pregnancy for vulvovaginal candidiasis. 1 Only intravaginal topical azole agents applied for 7 days are considered safe and effective. 1