What are the side effects of Jardiance (empagliflozin)?

Side Effects of Jardiance (Empagliflozin)

Jardiance causes genital mycotic infections (especially in women), urinary tract infections, and volume depletion as its most common side effects, while serious but rare complications include ketoacidosis, acute kidney injury, and Fournier's gangrene. 1

Common Side Effects

Genitourinary Infections

• Genital mycotic infections occur in approximately 6% of patients on SGLT2 inhibitors versus 1% on placebo, with significantly higher rates in females than males 2, 3
• Women may experience vaginal yeast infections with symptoms including vaginal odor, white or yellowish discharge, and vaginal itching 1
• Men, particularly uncircumcised males, may develop balanitis or balanoposthitis with redness, itching, swelling, rash, or foul-smelling discharge from the penis 1
• These infections can be managed with proper genital hygiene and over-the-counter antifungal medications 4
• Urinary tract infections may occur, though clinical trials show no significant difference in rates compared to placebo 4

Volume-Related Effects

• Empagliflozin causes osmotic diuresis leading to increased urinary frequency and volume depletion 2
• Dehydration may manifest as dizziness, faintness, lightheadedness, or weakness, especially upon standing (orthostatic hypotension) 1
• Blood pressure typically decreases by approximately 4 mmHg systolic and 2 mmHg diastolic 2
• Elderly patients and those taking diuretics are at higher risk for volume depletion and hypotension and require careful monitoring 4, 1

Metabolic Effects

• Low blood sugar (hypoglycemia) can occur when Jardiance is combined with insulin or sulfonylureas, requiring dose adjustments of these medications 1
• Symptoms of hypoglycemia include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking, dizziness, and sweating 1
• Increased LDL cholesterol may occur, though HDL cholesterol and triglycerides typically improve 5

Serious but Less Common Side Effects

Ketoacidosis

• Diabetic ketoacidosis (DKA) can occur even with normal blood glucose levels (euglycemic DKA), representing a life-threatening emergency 1, 6
• Symptoms include nausea, vomiting, abdominal pain, tiredness, and labored breathing 1
• Discontinue Jardiance immediately and seek emergency care if ketoacidosis is suspected 1
• Risk factors include insulin deficiency, acute illness, reduced food intake, surgery, or excessive alcohol consumption 1

Acute Kidney Injury

• Sudden kidney injury has been reported in patients taking Jardiance 1, 6
• Temporarily discontinue Jardiance during acute illness with reduced oral intake, vomiting, diarrhea, or excessive heat exposure 1
• Monitor renal function prior to initiation and periodically thereafter 1

Serious Urinary Tract Infections

• Serious UTIs including pyelonephritis and urosepsis requiring hospitalization have been reported 4, 1
• Symptoms include burning with urination, urinary urgency, urinary frequency, pelvic pain, blood in urine, fever, back pain, nausea, or vomiting 1

Fournier's Gangrene

• Necrotizing fasciitis of the perineum (Fournier's gangrene) has been reported in rare cases, though causal relationship remains unclear 4

Hypersensitivity Reactions

• Serious allergic reactions including urticaria and angioedema have occurred 1
• Symptoms include swelling of face, lips, throat, difficulty swallowing or breathing, and hives 1
• Discontinue Jardiance immediately and seek emergency care if hypersensitivity reactions occur 1

Special Population Considerations

Renal Impairment

• Glycemic efficacy is reduced when eGFR <45 mL/min/1.73m², though cardiovascular and renal protective benefits persist 4, 2
• Jardiance can be initiated if eGFR is above 20 mL/min/1.73 m² 2
• Continue Jardiance for cardiovascular and kidney benefits even when eGFR falls below 45 mL/min/1.73 m² until dialysis or transplantation 2
• Do not use in patients with severe kidney problems (eGFR <30 mL/min/1.73 m²) or on dialysis 1

Pregnancy and Breastfeeding

• Jardiance may harm the unborn fetus and should be avoided during pregnancy 1
• Breastfeeding is not recommended during treatment with Jardiance 1

Dose-Related Considerations

• No significant difference in adverse event rates between 10 mg and 25 mg doses for drug-related adverse effects, discontinuation rates, or serious adverse events 3
• Genital and urinary tract infections remain more common in females regardless of dose 3

Important Clinical Pitfalls

• Do not confuse the osmotic diuresis and increased urination as a treatment failure—this is the expected mechanism of action 2
• Elevated glucose in urinalysis is expected and should not prompt concern 1
• The cardiovascular benefits appear related to prevention of heart failure rather than prevention of atherosclerotic complications like myocardial infarction or stroke 7