Should Farxiga Be Held During a UTI?
Yes, temporarily withhold Farxiga (dapagliflozin) when a patient develops a urinary tract infection, particularly if the UTI is symptomatic, complicated, or the patient has risk factors for serious infection. The FDA label explicitly states to "withhold DAPAGLIFLOZIN TABLETS, if possible, in temporary clinical situations that could predispose patients to ketoacidosis" and to "resume DAPAGLIFLOZIN TABLETS when the patient is clinically stable and has resumed oral intake" 1.
Rationale for Holding Dapagliflozin
Increased Risk of Serious Urinary Infections
The FDA warns that dapagliflozin increases the risk of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization 1. The mechanism involves persistent glucosuria creating a favorable environment for bacterial growth in the urinary tract 1, 2.
Postmarketing surveillance has documented cases of septic shock and life-threatening infections in patients on dapagliflozin, particularly in immunosuppressed individuals 3. One case report described a 69-year-old immunosuppressed woman who developed septic shock within hours of admission for pyelonephritis while taking dapagliflozin 3.
The risk is particularly elevated in patients with urinary tract outlet obstruction or incomplete bladder emptying, where urinary stasis combined with drug-induced glucosuria creates ideal conditions for bacterial proliferation 4.
Clinical Decision Algorithm
Hold dapagliflozin if ANY of the following are present:
- Symptomatic UTI with systemic symptoms (fever, rigors, altered mental status, flank pain) 5, 1
- Complicated UTI (anatomic abnormalities, catheterization, diabetes with poor control, immunosuppression) 5
- Pyelonephritis or upper tract involvement 5, 1
- Male patients with evidence of bladder outlet obstruction 4
- Immunocompromised patients 3
- Patients requiring hospitalization for UTI 1
May continue with caution if ALL of the following are true:
- Uncomplicated lower UTI (cystitis only) in otherwise healthy female 5
- Mild symptoms without systemic involvement 2
- No history of recurrent UTIs on dapagliflozin 2
- Close monitoring is feasible 1
Evidence Supporting Temporary Discontinuation
Drug-Specific Data
Clinical trials demonstrated that 4.3-5.7% of dapagliflozin-treated patients developed diagnosed UTIs compared to 3.7% on placebo 2. While most infections were mild to moderate, the FDA label emphasizes that serious infections including urosepsis have occurred 1.
Urinary glucose excretion persists for 3 days after discontinuing dapagliflozin, though some cases report glucosuria lasting up to 2 weeks 1. This prolonged effect means the infection risk doesn't immediately resolve upon stopping the medication.
A 2025 comparative study found significantly higher urinary frequency (
55% vs ~25%) and urgency (48% vs ~20%) in patients taking 10 mg versus 5 mg dapagliflozin, suggesting dose-dependent effects on genitourinary symptoms 6.
UTI Management Guidelines
The European Association of Urology 2024 guidelines emphasize managing underlying complicating factors as a strong recommendation for complicated UTI treatment 5. Dapagliflozin-induced glucosuria represents a modifiable complicating factor.
For complicated UTIs, empirical treatment should include combination therapy with aminoglycosides plus beta-lactams or third-generation cephalosporins, with treatment duration of 7-14 days 5.
When to Resume Dapagliflozin
Resume dapagliflozin only after ALL of the following criteria are met:
- Complete resolution of UTI symptoms 1
- Patient is clinically stable and afebrile for at least 48 hours 5
- Completion of appropriate antibiotic course 5
- Patient has resumed normal oral intake 1
- Any underlying urological abnormalities have been addressed 5
Critical Pitfalls to Avoid
Do not continue dapagliflozin in patients with recurrent UTIs - if a patient develops multiple UTIs while on dapagliflozin, consider permanent discontinuation rather than repeated temporary holds 2, 3.
Do not restart dapagliflozin prematurely - the FDA specifically instructs to wait until the patient is "clinically stable" 1. Restarting during active infection or before completing antibiotics increases risk of treatment failure.
Do not ignore volume depletion - UTIs combined with dapagliflozin-induced osmotic diuresis can cause significant volume depletion, acute kidney injury, and hypotension 1. Assess volume status before restarting.
Screen for bladder outlet obstruction in males - one case series documented E. coli septicemia in a male patient with 180 mL post-void residual who had no further UTIs after permanently discontinuing dapagliflozin 4.
Special Populations Requiring Extra Caution
Immunosuppressed patients should have dapagliflozin held at the first sign of UTI, as they are at markedly increased risk for progression to septic shock 3.
Elderly patients and those on loop diuretics are at higher risk for volume depletion and should have volume status carefully assessed before restarting 1.
Patients with diabetes are already at increased risk for CA-UTI (catheter-associated UTI), with prolonged catheterization, female sex, and diabetes identified as key risk factors 5.