Jardiance Cancer Risk Signal Review: What the Evidence Actually Shows

What does the Jardiance label say about cancer?

Jardiance is empagliflozin, an oral SGLT2 inhibitor approved under NDA 204629 on 1 August 2014; the label in effect dates from 30 January 2026 [1][2]. It carries no boxed warning [1]. The Warnings and Precautions section has six items: ketoacidosis, volume depletion, genitourinary infections, hypoglycemia, lower limb amputation and serious hypersensitivity. Cancer is not among them [1]. The only contraindication is hypersensitivity to empagliflozin or any excipient in the tablet [1].

The adverse reactions section names urinary tract infections and female genital mycotic infections as the most common reactions. Its postmarketing list covers Fournier's gangrene, urosepsis, pyelonephritis, ketoacidosis, acute kidney injury, angioedema, rash, urticaria and constipation [1]. Neither list names a malignancy [1].

What did the large empagliflozin trials report?

EMPA-REG OUTCOME randomized 7,020 adults with type 2 diabetes at high cardiovascular risk. EMPEROR-Reduced enrolled 3,730 adults with heart failure and an ejection fraction of 40% or less, EMPEROR-Preserved 5,988 adults with an ejection fraction above 40%, and EMPA-KIDNEY 6,609 adults with chronic kidney disease [3][4][5][6]. Median follow-up across the four ran from 16 months to 3.1 years [3][4][5][6]. Each was built around a heart or kidney primary endpoint [3][4][5][6].

What the label flags in the urinary tract

The label states that Jardiance increases urinary glucose excretion and raises the risk of genitourinary infections, including urinary tract infections and genital mycotic infections, in both male and female patients [1]. In pooled placebo-controlled trials (four 24-week trials plus 18-week data from a trial with insulin), urinary tract infections were reported in 7.6% of placebo recipients, 9.3% taking Jardiance 10 mg and 7.6% taking Jardiance 25 mg, with 995, 999 and 977 people in the three arms [1]. Female genital mycotic infections were reported in 1.5%, 5.4% and 6.4% of women, and male genital mycotic infections in 0.4%, 3.1% and 1.6% of men, across the same arms [1]. Urosepsis, pyelonephritis and necrotizing fasciitis of the perineum (Fournier's gangrene) are the serious genitourinary events on the label [1].

The label directs monitoring for signs and symptoms of genitourinary infections, prompt treatment when indicated, and immediate evaluation of pain, tenderness, erythema or swelling in the genital or perineal area accompanied by fever or malaise for necrotizing fasciitis [1].