Treatment and Efficacy
Approved indications: Jardiance is approved in adults to reduce the risk of cardiovascular death and hospitalization for heart failure in heart failure of any ejection fraction, to slow chronic kidney disease progression and reduce kidney failure, cardiovascular death, and hospitalization in adults with CKD at risk of progression, to reduce cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and as an add-on to diet and exercise to improve glycemic control in adults and children 10 years and older with type 2 diabetes.
Off-label uses: Clinically meaningful off-label uses are limited because many earlier “off-label” roles (for heart failure or chronic kidney disease, including in people without diabetes) are now formally approved; use for type 1 diabetes or for general weight loss has been studied but is discouraged in routine practice because of ketoacidosis risk and limited benefit compared with approved options.
Efficacy expectations:
- Type 2 diabetes: Blood sugar levels begin to improve within days, with most of the HbA1c reduction (typically about 0.5% to 1%) seen over 3 months; modest weight loss (around 4–7 lb) and slight blood pressure reductions are common.
- Heart failure: Benefits on symptoms and reduced risk of hospitalization can appear within the first few weeks to months, with about a 20–30% relative reduction in combined cardiovascular death and heart-failure hospitalization compared with placebo on top of standard therapy.
- Chronic kidney disease: Jardiance slows the rate of kidney function decline and lowers the risk of kidney failure and kidney- or heart-related death, with event curves separating within months; effects are broadly similar to other SGLT2 inhibitors, and it is often chosen alongside them based on individual patient factors and formulary coverage.
Dosage and Administration
Typical dosing by indication and age:
- Adults (heart failure or chronic kidney disease indications): 10 mg by mouth once daily in the morning, with or without food; higher doses are not required for cardiorenal benefit.
- Adults (type 2 diabetes glycemic control): Start with 10 mg by mouth once daily; if tolerated and additional blood sugar lowering is needed, the dose may be increased to 25 mg once daily.
- Pediatric patients ≥10 years (type 2 diabetes glycemic control): 10 mg by mouth once daily, with possible increase to 25 mg once daily if needed and well tolerated.
- Renal function: For glycemic control, use is not recommended if eGFR is below 30 mL/min/1.73 m²; for heart failure and CKD indications, it can often be continued in moderate to severe impairment but has not been adequately studied in patients on dialysis.
How to take the medicine:
- Swallow the tablet whole once daily, preferably at the same time each morning, with or without food.
- Maintain adequate fluid intake, especially in hot weather, with vomiting/diarrhea, or when starting diuretics or blood-pressure medicines.
- When used with insulin or sulfonylureas, those doses may need to be reduced to lower the risk of hypoglycemia.
Special dosing instructions:
- Assess kidney function and volume status before starting, and periodically during treatment.
- Temporarily stop Jardiance at least 3 days before major surgery or procedures involving prolonged fasting, during severe acute illness, or when unable to eat or drink normally, to reduce ketoacidosis risk; restart when clinically stable and eating and drinking again.
Missed dose and overdose:
- Missed dose: Take the missed dose as soon as remembered the same day, but skip it if it is almost time for the next dose; do not double the next dose.
- Overdose: Seek urgent medical care or contact Poison Control (1-800-222-1222); monitoring and supportive care (especially for dehydration, low blood pressure, and electrolyte changes) are usually required.
Safety and Side Effects
Common side effects (usually mild to moderate):
- Genital yeast infections and urinary tract infections, especially in people with a history of these problems or in uncircumcised men; these often occur in the first months of therapy and are usually treatable.
- Increased urination, thirst, and mild dehydration, sometimes causing dizziness or low blood pressure, particularly in older adults or those on diuretics.
- Nausea, mild increases in cholesterol, and, in children and in adults using insulin or sulfonylureas, low blood sugar episodes.
Serious or rare adverse effects requiring immediate medical attention:
- Diabetic ketoacidosis (DKA) or other ketoacidosis, which can occur even with only moderately elevated or near-normal blood sugars; symptoms include nausea, vomiting, abdominal pain, deep or rapid breathing, unusual fatigue, or confusion.
- Severe genitourinary infections such as urosepsis, pyelonephritis (kidney infection), and necrotizing fasciitis of the perineum (Fournier’s gangrene), presenting with fever, feeling very ill, and severe pain, redness, or swelling in the genital or perineal area.
- Severe dehydration or acute kidney injury, with symptoms such as fainting, marked dizziness, or sharp decreases in urine output.
- Serious allergic reactions including angioedema (swelling of face, lips, tongue, or throat), hives, or difficulty breathing.
- Increased risk of lower-limb amputation in susceptible patients with severe peripheral artery disease, prior amputations, or diabetic foot ulcers, though the absolute risk remains low.
Warnings and precautions:
- Pregnancy: Use is generally avoided, especially in the second and third trimesters, because of potential effects on fetal kidney development.
- Breastfeeding: Not recommended while nursing, as it is unknown if the drug passes into human milk and there is potential risk to the infant’s kidneys.
- Children: Approved for glycemic control in type 2 diabetes only in patients 10 years and older; not established or recommended in younger children.
- Kidney disease: Can be used for heart failure and CKD indications in adults with moderate to severe impairment, but is not recommended when used only for blood sugar control if eGFR is below 30 mL/min/1.73 m², and is not studied in people on dialysis.
- Liver disease, elderly, or volume depletion: Use with caution because of higher risks of low blood pressure, dehydration, and kidney injury.
- Type 1 diabetes or history of ketoacidosis: Not recommended due to substantially increased risk of DKA.
Safety compared with other options and reporting side effects:
- Overall, Jardiance has a safety profile similar to other SGLT2 inhibitors, with class-characteristic risks of genitourinary infections, volume depletion, and ketoacidosis, but generally low rates of severe events when patients are carefully selected and monitored.
- Suspected side effects can be reported to the FDA MedWatch program (online or by calling 1-800-FDA-1088), and updated safety communications can be found on the FDA and manufacturer websites.
Interactions and Precautions
Drug, supplement, food, and alcohol interactions:
- Other diabetes medicines: Insulin and sulfonylureas increase the risk of hypoglycemia when combined with Jardiance, so their doses may need reduction.
- Diuretics and blood-pressure–lowering drugs: Loop and thiazide diuretics, ACE inhibitors, ARBs, and other antihypertensives can add to the blood-pressure–lowering and volume-depleting effects, increasing risk of dizziness, fainting, and kidney injury.
- Nephrotoxic agents and NSAIDs: Frequent use of NSAIDs or other nephrotoxic drugs may raise the risk of acute kidney injury when combined with Jardiance, especially in dehydrated or elderly patients.
- Digoxin and other transport-substrate drugs: Empagliflozin can cause small changes in digoxin levels; clinically significant effects are uncommon but may warrant closer monitoring in high-risk patients.
- Alcohol: Heavy or binge drinking increases the risk of dehydration and ketoacidosis; alcohol should be limited and avoided during illness or fasting.
- Foods and diagnostic procedures: There are no major food interactions; SGLT2 inhibition causes glucose to appear in the urine, which can affect urine glucose tests but not standard blood glucose measurements.
Conditions and co-medications that require extra caution:
- History of diabetic ketoacidosis, very low-carbohydrate or ketogenic diets, or factors that predispose to ketosis (e.g., severe illness, major surgery, heavy alcohol use, reduced insulin doses).
- Chronic or recurrent genital or urinary tract infections.
- Peripheral artery disease, previous amputations, or chronic foot ulcers, due to small but real amputation risk.
- Moderate to severe kidney disease, liver disease, low blood pressure, advanced age, or use of high-dose diuretics.
Monitoring needs:
- Kidney function (serum creatinine and eGFR) at baseline and periodically.
- Blood pressure, volume status, and body weight, especially after initiation or dose changes of diuretics or antihypertensives.
- Blood glucose and HbA1c for diabetes control; in high-risk situations, consider blood or urine ketone monitoring.
- Feet, perineal, and genital areas for signs of infection, sores, or ulcers.
Disposal Guidance
Storage: Store Jardiance tablets at room temperature (68°F to 77°F / 20°C to 25°C), in a tightly closed container, protected from excessive heat, moisture, and light, and keep out of reach of children and pets.
Disposal: If tablets are expired or no longer needed, use a local drug take-back program when available, or mix the tablets (do not crush for your own use) with an undesirable substance such as used coffee grounds or cat litter, seal in a bag or container, and place in household trash; do not flush down the toilet unless specifically instructed by local guidance or the product label.
Common Questions and Answers
Q: What is Jardiance used for?
A: Jardiance is an oral SGLT2 inhibitor used to improve blood sugar control in adults and children 10 years and older with type 2 diabetes, and in adults it also reduces the risk of cardiovascular death and hospitalization in heart failure and slows progression and complications of certain forms of chronic kidney disease.
Q: How long does it take for Jardiance to start working?
A: Jardiance begins lowering blood sugar within days, but the full effect on HbA1c and on outcomes like heart-failure hospitalizations or kidney function is usually evaluated over weeks to months, typically around 3 months for blood sugar and longer for cardiovascular and kidney outcomes.
Q: Will I lose weight on Jardiance?
A: Many people lose a modest amount of weight (often a few pounds) over several months because extra glucose calories are lost in the urine, but Jardiance is not approved or used primarily as a weight-loss drug.
Q: Can I take Jardiance if I have kidney problems?
A: Jardiance is specifically approved to slow chronic kidney disease progression and reduce related risks in many adults with CKD, but its ability to lower blood sugar decreases when kidney function is poor, and it is not recommended solely for glycemic control at very low eGFR or in people on dialysis, so individual dosing and suitability must be assessed by a clinician.
Q: Is it safe to drink alcohol while taking Jardiance?
A: Light to moderate alcohol use may be acceptable for some people, but heavy drinking or drinking while fasting or ill can increase the risk of dehydration and ketoacidosis with Jardiance, so alcohol should be limited and avoided in higher-risk situations.