What are the side effects of Jardiance (empagliflozin)?

Side Effects of Jardiance (Empagliflozin)

Jardiance carries a risk of serious adverse effects including ketoacidosis, serious urinary tract infections, acute kidney injury, genital mycotic infections, and volume depletion, with the most common manageable side effects being genital infections (especially in women) and mild urinary tract infections. 1

Serious Side Effects Requiring Immediate Medical Attention

Ketoacidosis (Most Critical)

• Ketoacidosis can occur even when blood sugar is less than 250 mg/dL, making it particularly dangerous because patients may not recognize they are at risk 1
• Stop Jardiance immediately and seek emergency care if you experience: nausea, vomiting, abdominal pain, tiredness, or trouble breathing 1
• Risk is elevated during insulin pump malfunctions, significant insulin dose reductions, prolonged fasting, or carbohydrate restriction 2
• This serious complication may require hospitalization and can be fatal if untreated 1

Serious Urinary Tract Infections

• May lead to hospitalization in some patients 1
• Watch for: burning sensation during urination, frequent urination, urgent need to urinate, pelvic pain, blood in urine, fever, back pain, nausea, or vomiting 1

Acute Kidney Injury

• Sudden kidney injury has occurred in patients taking Jardiance, particularly when fluid intake is reduced or fluid losses increase 1
• Contact your doctor immediately if you reduce food or liquid intake (e.g., due to illness) or experience fluid losses from vomiting, diarrhea, or excessive sun exposure 1
• The drug should be used with caution in patients with renal insufficiency (eGFR <45 mL/min/1.73 m²) 3

Severe Allergic Reactions

• Symptoms include: swelling of face, lips, throat, or other skin areas; difficulty swallowing or breathing; raised red areas on skin (hives) 1
• Stop Jardiance and seek emergency medical care immediately if these occur 1

Common and Manageable Side Effects

Genital Mycotic Infections

• Occur more frequently, especially in women, but are usually straightforward to manage 4, 5
• These infections are typically mild and respond well to standard antifungal treatments 5

Urinary Tract Infections

• A negligible increase in mild urinary tract infections may occur 4
• Most cases are manageable with standard antibiotic therapy 5

Volume Depletion and Hypotension

• Risk of hypotension and volume depletion is generally low (symptomatic hypotension occurred in only 0.3-5.7% of patients in clinical trials) 6
• Higher risk in patients taking diuretics or antihypertensive medications concurrently 1, 4
• Should be carefully monitored in elderly patients, those with renal impairment, or patients on loop diuretics 4

Metabolic Changes

• Increased fats in blood (cholesterol) 1
• Therapeutic glucosuria (sugar in urine) is expected and will show up on urine tests 1

Hypoglycemia Risk (Context-Dependent)

• Jardiance alone does not cause hypoglycemia because it works independently of insulin secretion 3
• Risk increases significantly when combined with insulin or sulfonylureas, requiring dose adjustments of these medications 1
• Symptoms to watch for: headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking, dizziness, sweating 1

Special Population Warnings

Pregnancy and Breastfeeding

• Not recommended during pregnancy due to potential effects on fetal renal development 2
• Not recommended while breastfeeding due to potential effects on postnatal renal development 2

Important Clinical Pitfalls to Avoid

• Do not assume ketoacidosis is absent based on blood glucose levels alone—it can occur with glucose <250 mg/dL 1
• Monitor for volume depletion more carefully when combining with other diuretics or in elderly patients 4
• Adjust insulin or sulfonylurea doses downward when initiating Jardiance to prevent hypoglycemia 1
• Temporarily discontinue during periods of reduced oral intake or increased fluid losses to prevent acute kidney injury 1
• Efficacy decreases with declining renal function (eGFR <45 mL/min/1.73 m²), though cardiovascular and renal protective benefits may persist 3, 5

Cardiovascular and Renal Benefits Context

While discussing side effects, it's important to note that Jardiance demonstrated significant reductions in cardiovascular death (38%), all-cause mortality (32%), and heart failure hospitalizations in patients with type 2 diabetes and established cardiovascular disease 3, 5. These benefits appear independent of glucose-lowering effects and represent direct cardiovascular protection 6.