Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that has demonstrated favorable efficacy in the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease. As a prescription medication, it is also associated with a range of potential side effects and serious risks that require high vigilance.

What Are the Side Effects of Empagliflozin?

Urinary System-Related Side Effects

Urinary tract infections (UTIs): The incidence rate ranges from 7.6% to 9.3%, including urinary tract infections, asymptomatic bacteriuria, cystitis, etc. The risk is particularly higher in female patients, with an incidence rate of 16.6% to 18.4%, compared to 3.2% to 4.1% in male patients.

The incidence rate in female patients (16.6%-18.4%) is higher than that in male patients (3.2%-4.1%). Patients with a history of chronic or recurrent urinary tract infections face an even higher risk.

Reproductive System-Related Side Effects

Genitourinary tract fungal infections in females: The incidence rate is as high as 5.4% to 6.4%, including vulvovaginal fungal infections, vaginal infections, vulvitis, vaginal candidiasis, etc. Patients with a history of chronic or recurrent infections have an increased risk.

Genital fungal infections in males: The incidence rate is 1.6% to 3.1%, and symptoms may include balanoposthitis, balanitis, fungal genital infections, etc. Uncircumcised males are at a relatively higher risk.

Serious Side Effects of Empagliflozin Requiring High Vigilance

Risk of Ketoacidosis

Patients with type 1 diabetes mellitus: Empagliflozin significantly increases the risk of developing ketoacidosis (a life-threatening condition) beyond the background incidence rate.

Patients with type 2 diabetes mellitus and pancreatic diseases (e.g., history of pancreatitis or pancreatic surgery) are also high-risk groups for ketoacidosis.

Perineal Necrotizing Fasciitis (Fournier's Gangrene)

Description: This is a rare but severe and life-threatening necrotizing infection that requires emergency surgical intervention.

Symptom Recognition: Patients may experience pain or tenderness, erythema (redness), or swelling in the genital or perineal area, accompanied by fever or malaise.

Severe Urinary Tract Infections

There have been cases where patients receiving Empagliflozin treatment developed severe urinary tract infections requiring hospitalization, including urosepsis and pyelonephritis.

Precautions for Empagliflozin Administration

Pre-Administration Assessment

Renal function assessment: It is recommended to assess renal function before initiating Empagliflozin treatment and to re-evaluate it when clinically necessary.

Recognition and Management of Ketoacidosis

Inform all patients about the signs and symptoms of ketoacidosis, including nausea, vomiting, abdominal pain, fatigue, and difficulty breathing.

If symptoms of ketoacidosis occur, instruct patients to stop taking Empagliflozin and seek medical attention immediately.

Fluid Management and Dehydration Prevention

This is especially important in hot weather, if the patient reduces dietary intake or fluid consumption, or begins to lose fluids (e.g., due to vomiting, diarrhea, or prolonged exposure to the sun).

Healthcare providers should advise patients to maintain adequate fluid intake and closely monitor for early signs of dehydration (e.g., dizziness, weakness, feeling faint when standing, etc.).