From the Guidelines
Yes, Jardiance (empagliflozin) may increase the risk of urinary tract infections (UTIs) [ 1 ]. As a sodium-glucose cotransporter 2 (SGLT2) inhibitor, Jardiance works by removing excess glucose from the body through urine, which can lead to changes in the urinary tract that may increase the risk of UTIs.
Key Points to Consider
- Patients taking Jardiance, especially women, should be aware of this potential risk and report any symptoms of UTIs, such as burning during urination, frequent urination, or abdominal pain, to their healthcare provider [ 1 ].
- The risk of UTIs with Jardiance is a known adverse effect, and patients with a history of recurrent UTIs should be monitored closely while taking Jardiance [ 1 ].
- Genital mycotic infections are also a known complication of SGLT2 inhibitors, and daily hygienic measures may lessen this risk [ 1 ].
- It is essential to evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated [ 1 ].
From the FDA Drug Label
There have been reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization in patients receiving JARDIANCE. Treatment with JARDIANCE increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated [see Adverse Reactions (6)].
Jardiance (Empagliflozin) increases the risk of Urinary Tract Infections (UTI), including serious infections such as urosepsis and pyelonephritis. Patients should be evaluated for signs and symptoms of UTI and treated promptly if indicated 2.
From the Research
Incidence of Urinary Tract Infections (UTIs) with Jardiance (Empagliflozin)
- The incidence of UTIs in patients taking empagliflozin has been studied in several trials, with varying results 3, 4, 5, 6, 7.
- A real-world observational study found that patients treated with SGLT2 inhibitors, including empagliflozin, had a higher incidence of UTIs compared to those treated with non-SGLT2 inhibitors, with an incidence rate of 33.03% for empagliflozin 3.
- An analysis of the FDA Adverse Event Reporting System found a strong association between SGLT2 inhibitors, including empagliflozin, and UTIs, with a potential positive signal for UTIs identified for empagliflozin 4.
- A retrospective chart review of patients with concurrent catheter use and empagliflozin treatment found no statistically significant difference in UTI rates when comparing catheters alone to concurrent catheter and empagliflozin use 5.
- A systematic review and meta-analysis of randomized controlled trials found that SGLT2 inhibitors, including empagliflozin, were not associated with an increased risk of UTIs overall, although higher doses of dapagliflozin were associated with an increased risk 6.
- A pooled safety and tolerability analysis of empagliflozin in patients with type 2 diabetes mellitus found that the incidence of events consistent with UTIs was similar for the empagliflozin group versus placebo 7.
Risk Factors for UTIs with Empagliflozin
- A real-world observational study found that patients of female gender and older age had a significantly higher risk of UTIs when treated with SGLT2 inhibitors, including empagliflozin 3.
- A pooled safety and tolerability analysis found that history of UTI was identified as a risk factor for UTI during treatment with empagliflozin 7.
- A systematic review and meta-analysis found that higher doses of dapagliflozin were associated with an increased risk of UTIs, although this was not found for empagliflozin 6.
Comparison to Other SGLT2 Inhibitors
- A real-world observational study found that the incidence rates of UTIs were not different between dapagliflozin and empagliflozin treatment 3.
- An analysis of the FDA Adverse Event Reporting System found a strong association between SGLT2 inhibitors, including empagliflozin, dapagliflozin, canagliflozin, and ertugliflozin, and UTIs 4.
- A systematic review and meta-analysis found that SGLT2 inhibitors, including empagliflozin, dapagliflozin, and canagliflozin, were associated with an increased risk of genital tract infections, although the risk of UTIs was not increased overall 6.