Does Farxiga Cause Bladder Cancer? FDA Findings

What does the FDA label say about bladder cancer?

The Farxiga prescribing information effective June 3, 2026, contains no bladder cancer warning, and it contains no lower limb amputation warning either [1][2]. It also carries no boxed warning [1]. What it does warn about is ketoacidosis, volume depletion and acute kidney injury, genitourinary infections including urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier gangrene) and genital mycotic infections, and hypoglycemia when Farxiga is used with insulin or an insulin secretagogue [1].

What did DECLARE-TIMI 58 measure?

DECLARE-TIMI 58 enrolled 17,160 adults with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease [3]. Participants received dapagliflozin 10 mg or placebo and were followed for a median of 4.2 years [3]. The trial's primary outcomes were major adverse cardiovascular events and a composite of cardiovascular death or hospitalization for heart failure; secondary outcomes included a renal composite and death from any cause [3]. Diabetic ketoacidosis occurred in 0.3% of the dapagliflozin group versus 0.1% of the placebo group [3].

What genitourinary risks does the label list?

The label's genitourinary warnings are about infections [1]. In a pooled analysis of 12 placebo-controlled trials in adults with type 2 diabetes, female genital mycotic infections occurred in 8.4% with dapagliflozin 5 mg and 6.9% with 10 mg, versus 1.5% with placebo [1]. Male genital mycotic infections occurred in 2.8% and 2.7%, versus 0.3% with placebo [1]. Urinary tract infections occurred in 5.7% and 4.3%, versus 3.7% with placebo [1].

The label describes the serious end of that spectrum: urosepsis, pyelonephritis, and Fournier gangrene, a rare life-threatening infection requiring urgent surgical intervention, with cases requiring hospitalization and outcomes including multiple surgeries and death [1]. The label says that patients with pain, tenderness, erythema or swelling in the genital or perineal area, along with fever or malaise, should be evaluated immediately for necrotizing fasciitis [1].

What other risks does the label name?

The label also names ketoacidosis, which can present with blood glucose below 250 mg/dL and has been reported fatally in type 2 diabetes [1]. Volume depletion and acute kidney injury carry higher risk at eGFR under 60, in older adults and in people on loop diuretics [1]. Hypoglycemia is a concern when Farxiga is combined with insulin or a sulfonylurea [1]. The label states that Farxiga is not recommended for glycemic control in type 1 diabetes, where it significantly increases the risk of diabetic ketoacidosis [1].