Does Farxiga (dapagliflozin) cause urinary symptoms?

From the Guidelines

Farxiga (dapagliflozin) is associated with urinary symptoms, including urinary tract infections (UTIs) and genital yeast infections, as a result of its mechanism of action, which increases glucose excretion in the urine. This medication works by helping the kidneys remove glucose from the bloodstream through urine, creating an environment where bacteria and fungi can thrive 1. According to the 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes, the adverse effects to monitor for SGLT2 inhibitors, including dapagliflozin, include genital fungal infections and urinary tract infections 1.

Key Points to Consider

• The increased sugar in the urine creates an environment where bacteria and fungi can thrive, leading to UTIs and genital yeast infections 1.
• Women may experience UTIs at rates of 4-8%, while men have slightly lower rates, and genital yeast infections occur in about 5-10% of women and 3-4% of men taking Farxiga 1.
• To reduce these risks, patients should maintain good hygiene, stay well-hydrated, urinate after sexual activity, and contact their healthcare provider if they experience burning during urination, cloudy urine, unusual discharge, or genital itching.
• These side effects, while common, rarely require discontinuation of the medication, and the benefits of Farxiga in reducing cardiovascular risk and improving glycemic control often outweigh the risks of urinary symptoms 1.

Recommendations for Patients Taking Farxiga

• Monitor for signs and symptoms of UTIs and genital yeast infections, such as burning during urination, cloudy urine, unusual discharge, or genital itching 1.
• Maintain good hygiene and stay well-hydrated to reduce the risk of UTIs and genital yeast infections 1.
• Contact your healthcare provider if you experience any symptoms of UTIs or genital yeast infections, or if you have concerns about the risks and benefits of Farxiga 1.

From the FDA Drug Label

DAPAGLIFLOZIN TABLETS may cause serious side effects, including: • Serious urinary tract infections. • changes in urination, including urgent need to urinate more often, in larger amounts, or at night Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure which is believed to be mediated by increased tubuloglomerular feedback. Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following the administration of dapagliflozin Dapagliflozin doses of 5 or 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day at Week 12. This urinary glucose excretion with dapagliflozin also results in increases in urinary volume [see Adverse Reactions (6. 1)].

Yes, Farxiga (dapagliflozin) may cause urinary symptoms, including:

• Serious urinary tract infections
• Changes in urination, such as an urgent need to urinate more often, in larger amounts, or at night
• Increases in urinary volume 2 2

From the Research

Urinary Symptoms Associated with Farxiga (Dapagliflozin)

• Farxiga (dapagliflozin) has been associated with an increased risk of urinary tract infections (UTIs) in patients with type 2 diabetes 3, 4, 5, 6, 7.
• The incidence of UTIs in patients taking dapagliflozin has been reported to be around 3.6-5.7% 3 and 5.3% 4.
• UTIs were generally mild to moderate and responded to standard antimicrobial treatment 3, 4.
• The dose strength of dapagliflozin was not associated with an increased risk of UTIs in some studies 4, while others found a slightly increased risk with higher doses 3.
• Female patients and those older than 50 years were found to be at a higher risk of developing UTIs while taking dapagliflozin 4, 7.
• Dapagliflozin was found to be well-tolerated in patients with diabetes, but caution should be taken when used in patients at risk of urinary tract infections and dehydration 6.

Risk Factors for Urinary Tract Infections

• Patients treated with SGLT2 inhibitors, including dapagliflozin, had a higher risk of UTIs compared to those treated with non-SGLT2 inhibitors 7.
• Significant risk factors for UTIs found in patients taking dapagliflozin included gender, age, and occupation 7.
• Female patients and those of older age had a significantly higher risk of UTIs when treated with SGLT2 inhibitors, whereas those with permanent jobs had a lower risk 7.