EMPAGLIFLOZIN

Background and Date of Approval

Empagliflozin is an antidiabetic medication approved by the Food and Drug Administration (FDA) on August 1, 2014. It is indicated to improve glycemic control in adults with type 2 diabetes, reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and lower the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure.

Uses

Empagliflozin helps reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure, lowers the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and improves glycemic control in adults with type 2 diabetes when combined with diet and exercise.

How is it administered?

Empagliflozin should be taken as directed, once daily in the morning, with or without food. Do not break, crush, or chew the tablets. For dosage instructions, consult a healthcare professional. Do not skip or double the dose.

Side Effects

Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them. Common side effects of Empagliflozin: Urinary tract infections Genital yeast infections Increased urination Thirst Fatigue Nausea Serious side effects of Empagliflozin: Ketoacidosis (high ketone levels in blood or urine) Dehydration (dizziness, fainting, light-headedness) Low blood sugar (hypoglycaemia) Kidney problems or sudden worsening of kidney function Urinary tract infections with serious complications (e.g., pyelonephritis) Bone fractures (in some cases) Serious allergic reactions (rash, itching, swelling, trouble breathing)

Warnings

Ketoacidosis: Can cause life-threatening ketoacidosis, even with blood sugar <250 mg/dL. Seek immediate medical help if nausea, vomiting, abdominal pain, or shortness of breath occur. Volume Depletion: This may lead to dehydration, low blood pressure, and kidney injury. Watch for dizziness, light-headedness, or reduced urine output. Urinary Tract Infections: Increases risk of serious infections like urosepsis and pyelonephritis. Seek medical attention for fever, chills, or burning during urination. Hypoglycemia: The Risk increases when used with insulin or insulin secretagogues. Adjust doses as directed to avoid low blood sugar. Fournier’s Gangrene: A Rare, serious genital infection. Seek emergency care for genital pain, swelling, redness, or fever. Genital Mycotic Infections: Higher risk of fungal infections. Report itching, redness, or unusual discharge. Hypersensitivity Reactions: Serious allergic reactions can occur. Stop the drug and seek emergency help for swelling, difficulty breathing, or rash.

Precautions

Before starting empagliflozin, assess for factors that may increase the risk of ketoacidosis, such as insulin deficiency, dehydration, or heavy alcohol use. Monitor kidney function, especially in elderly patients or those with impaired renal function. Stay hydrated, and adjust insulin or sulfonylurea doses to prevent hypoglycemia when used together. Discontinue the drug before surgery or during prolonged fasting.

Word of Advice

Take empagliflozin exactly as prescribed by your doctor. Maintain adequate hydration and monitor blood sugar levels regularly. Watch for signs of ketoacidosis including nausea, vomiting, or abdominal pain. Inform your doctor of any unusual symptoms, including genital infections or indicators of dehydration. Avoid alcohol and inform your doctor before undergoing surgery or prolonged fasting.

References

1. Sizar O, Podder V, Talati R. Empagliflozin. [Updated 2023 May 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532925/ 2. Forycka J, Hajdys J, Krzemińska J, Wilczopolski P, Wronka M, Młynarska E, Rysz J, Franczyk B. New Insights into the Use of Empagliflozin-A Comprehensive Review. https://pmc.ncbi.nlm.nih.gov/articles/PMC9775057/ 3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf 4. https://www.ema.europa.eu/en/documents/product-information/jardiance-epar-product-information_en.pdf

Frequently Asked Questions

What is empagliflozin used for?

Empagliflozin is used to help manage blood sugar levels in adults with type 2 diabetes. It may also reduce the risk of heart-related complications in people with type 2 diabetes and established heart disease.

Is empagliflozin safe to use with insulin?

Yes, empagliflozin can be used with insulin, but it may increase the risk of low blood sugar (hypoglycemia). Your doctor may adjust your insulin dose to minimise this risk. Monitor your blood sugar regularly and be alert for signs of hypoglycemia, such as shakiness, sweating, or confusion. Always follow your doctor’s instructions regarding insulin adjustments.

What should I avoid while taking empagliflozin?

Avoid dehydration, excessive alcohol, and prolonged fasting. Also, consult your doctor before stopping or starting any new medications. Additionally, be cautious with activities that may lead to dehydration, such as intense exercise in hot weather.

How does empagliflozin work?

Empagliflozin works by blocking a protein in the kidneys called SGLT2, which helps the body remove excess sugar through urine. This lowers blood sugar levels and may also help with weight loss.

How long does it take for empagliflozin to lower blood sugar?

Empagliflozin starts working within a few days, but it may take several weeks to see the full effect on blood sugar levels. Regular monitoring is important.

Available Brands 1

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS