Drug products: Diflucan, Diflucan®, Fluconazol Actavis, Fluconazol Aurobindo, Fluconazol Bluefish, Fluconazol Copyfarm, Fluconazol Fresenius Kabi, Fluconazol Hexal, Fluconazol HEXAL, Fluconazol Krka, Fluconazol Navamedic, Fluconazol Pharmathen, Fluconazol Takeda, Fluconazole, Fluconazole Abacus Medicine, Fluconazole Accord, Fluconazole B. Braun, Fluconazole Baxter, Fluconazole CC Pharma, Flukonazol 2care4, Flukonazol Ebb, Flukonazol Medartuum, Flukonazol Mylan, Larfungo, Solona
ATC code: J02AC01
Published controlled studies on differences between men and women regarding fluconazole efficacy in adults are lacking.
Pharmacokinetics and dosing
A pharmacokinetic study in healthy volunteers (26 men, 33 women) receiving an oral dose of fluconazole 100 mg showed that women had 36% higher Cmax, 17% lower volume of distribution and 20% shorter half-life than men, after adjusting for total bodyweight. The authors suggest that the observed differences in volume of distribution are likely because of differences in total body water, which generally is higher in men . Similar results were observed in a study in Chinese volunteers (5 men, 5 women) receiving fluconazole 200 mg single dose . A study in HIV-positive patients (93 men, 29 women) observed no effect on patient’s sex on fluconazole pharmacokinetics .
Fluconazole efficacy was compared with nystatin in a randomized study in immunocomprised children with oropharyngeal thrush (in total 182, 5 months-14 years old). No differences in responses between girls and boys were observed (data not shown). Reported side effects were not stratified by patient's sex .
Fluconazole has been associated with rare cases of serious hepatic toxicity, but no obvious relationship to sex or age of the patient has been observed. Caution is recommended if fluconazole is used in patients with liver dysfunction .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-08-02
- Carrasco-Portugal Mdel C, Flores-Murrieta FJ. Gender differences in the oral pharmacokinetics of fluconazole. Clin Drug Investig. 2007;27:851-5. PubMed
- Guo T, Sun WJ, Xia DY, Zhao LS. The pharmacokinetics of fluconazole in healthy Chinese adult volunteers: influence of ethnicity and gender. J Clin Pharm Ther. 2010;35:231-7. PubMed
- Csajka C, Décosterd LA, Buclin T, Pagani JL, Fattinger K, Bille J et al. Population pharmacokinetics of fluconazole given for secondary prevention of oropharyngeal candidiasis in HIV-positive patients. Eur J Clin Pharmacol. 2001;57:723-7. PubMed
- Flynn PM, Cunningham CK, Kerkering T, San Jorge AR, Peters VB, Pitel PA et al. Oropharyngeal candidiasis in immunocompromised children: a randomized, multicenter study of orally administered fluconazole suspension versus nystatin The Multicenter Fluconazole Study Group. J Pediatr. 1995;127:322-8. PubMed
- Diflucan (flukonazol). Summary of Product Characteristics. Medical Products Agency Sweden; 2015.
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-08-02.] Socialstyrelsens statistikdatabas
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson