Clinical risk factors predicting genital fungal infections with sodium–glucose cotransporter 2 inhibitor treatment: The ABCD nationwide dapagliflozin audit


      • Dapaglilfozin, an SGLT2 inhibitor, increases the risk of genital fungal infections.
      • Women are at much greater risk of developing genital infections with dapagliflozin.
      • Patients with prior genital fungal infection are also at greater risk.
      • Higher baseline HbA1c or BMI did not increase treatment-related genital infections.
      • Rates of dapagliflozin discontinuation due to genital infections were low.



      Treatment of type 2 diabetes with sodium–glucose cotransporter 2 (SGLT2) inhibitors may result in genital fungal infections. We investigated possible risk factors for developing such infections among patients treated with the SGLT2 inhibitor dapagliflozin.


      The Association of British Clinical Diabetologists (ABCD) collected data on patients treated with dapagliflozin in routine clinical practice from 59 diabetes centres. We assessed possible associations of patient’s age, diabetes duration, body mass index, glycated haemoglobin, renal function, patient sex, ethnicity and prior genital fungal infection, urinary tract infection, urinary incontinence or nocturia, with the occurrence of ≥1 genital fungal infection within 26 weeks of treatment.


      1049 out of 1116 patients (476 women, 573 men) were analysed. Baseline characteristics were, mean ± SD, age 56.7 ± 10.2 years, BMI 35.5 ± 6.9 kg/m2 and HbA1c 9.4 ± 1.5%. Only patient sex (13.2% women vs 3.3% men) and prior history of genital fungal infection (21.6% vs 7.3%) were found to be associated with occurrence of genital fungal infections after dapagliflozin treatment, adjusted OR 4.22 [95%CI 2.48,7.19], P < 0.001 and adjusted OR 2.41 [95% CI 1.04,5.57], P = 0.039, respectively.


      Women and patients with previous genital fungal infections had higher risks of developing genital fungal infections with dapagliflozin treatment.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic and Personal
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Primary Care Diabetes
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • DeFronzo R.A.
        • Davidson J.A.
        • Del Prato S.
        The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia.
        Diabetes Obes. Metab. 2012; 14: 5-14
        • Heerspink H.J.
        • Perkins B.A.
        • Fitchett D.H.
        • Husain M.
        • Cherney D.Z.
        Sodium glucose cotransporter 2 inhibitors in the treatment of diabetes mellitus: cardiovascular and kidney effects, potential mechanisms, and clinical applications.
        Circulation. 2016; 134: 752-772
        • Zinman B.
        • Wanner C.
        • Lachin J.M.
        • Fitchett D.
        • Bluhmki E.
        • Hantel S.
        • et al.
        Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes.
        N. Engl. J. Med. 2015; 373: 2117-2128
        • Inzucchi S.E.
        • Bergenstal R.M.
        • Buse J.B.
        • Diamant M.
        • Ferrannini E.
        • Nauck M.
        • et al.
        Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes.
        Diabetes Care. 2015; 38: 140-149
        • Ptaszynska A.
        • Johnsson K.M.
        • Parikh S.J.
        • De Bruin T.W.A.
        • Apanovitch A.M.
        • List J.F.
        Safety profile of dapagliflozin for type 2 diabetes: pooled analysis of clinical studies for overall safety and rare events.
        Drug Saf. 2014; 37: 815-829
        • Johnsson K.M.
        • Ptaszynska A.
        • Schmitz B.
        • Sugg J.
        • Parikh S.J.
        • List J.F.
        Urinary tract infections in patients with diabetes treated with dapagliflozin.
        J. Diabetes Complicat. 2013; 27: 473-478
        • Rosenstock J.
        • Ferrannini E.
        Euglycemic diabetic ketoacidosis: a predictable, detectable and preventable safety concern with SGLT2 inhibitors.
        Diabetes Care. 2015; 38: 1638-1642
        • Geerlings S.
        • Fonseca V.
        • Castro-Diaz D.
        • List J.
        • Parikh S.
        Genital and urinary tract infections in diabetes: impact of pharmacologically-induced glucosuria.
        Diabetes Res. Clin. Pract. 2014; 103: 373-381
        • Johnsson K.M.
        • Ptaszynska A.
        • Schmitz B.
        • Sugg J.
        • Parikh S.J.
        • List J.F.
        Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin.
        J. Diabetes Complicat. 2013; 27: 479-484
        • Nyirjesy P.
        • Sobel J.D.
        • Fung A.
        • Mayer C.
        • Capuano G.
        • Ways K.
        • et al.
        Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical outcomes.
        Curr. Med. Res. Opin. 2014; 30: 1109-1119
        • Inagaki N.
        • Kondo K.
        • Yoshinari T.
        • Maruyama N.
        • Susuta Y.
        • Kuki H.
        Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study.
        Diabetes Obes. Metab. 2013; 15: 1136-1145
        • Yale J.F.
        • Bakris G.
        • Cariou B.
        • Yue D.
        • David-Neto E.
        • Xi L.
        • et al.
        Efficacy and safety of canagliflozin in subjects with type 2 diabetes and chronic kidney disease.
        Diabetes Obes. Metab. 2013; 15: 463-473
      1. Forxiga (dapagliflozin). Prescribing Information, 2012, Available at: (Revised October 2016).