Type 2 diabetesActive ingredient
Empagliflozin
SGLT2 inhibitor1 FDA label read
Empagliflozin is sold as Jardiance, and its label reaches well beyond blood sugar. Alongside improving glycemic control in type 2 diabetes, it is approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, and to slow the decline of kidney function in adults with chronic kidney disease - the last two regardless of whether the person has diabetes.
Highlights of the labels
- Jardiance
- Type 2 diabetes, heart failure, chronic kidney diseasecovers type 2 diabetes
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| JardianceBoehringer Ingelheim Pharmaceuticals, Inc. | What its label approvesType 2 diabetes, heart failure, chronic kidney diseaseCovers type 2 diabetes | SupplyPrescription | Label version30 January 2026 |
How it works
Empagliflozin blocks SGLT2, the transporter in the kidney that returns filtered glucose from urine back into the blood. With the transporter inhibited, more glucose leaves the body with urine and blood glucose falls. The mechanism works in the kidney rather than through insulin.
Mechanism of action, Jardiance label
Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.
What the FDA approved it for
The approved uses, as worded in the label.
- JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
- JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
- To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
- It may increase the risk of diabetic ketoacidosis in these patients.
- JARDIANCE is not expected to be effective in these populations.
Forms and strengths
The presentations and strengths listed in the label.
- JARDIANCE tablets available as: 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with "S 10" on one side and the Boehringer Ingelheim company symbol on the other side. 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with "S 25" on one side and the Boehringer Ingelheim company symbol on the other side.
- Tablets: 10 mg, 25 mg
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating.
- Recommended dosage is 10 mg orally once daily in the morning, taken with or without food.
- For additional glycemic control, dosage may be increased to 25 mg orally once daily in patients tolerating JARDIANCE.
- Withhold JARDIANCE for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting.
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.
Warnings and precautions
The warnings and precautions section of the label.
- Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue JARDIANCE if ketoacidosis is suspected.
- Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.
- Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections: Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated.
- Hypoglycemia: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher regardless of insulin use. Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE.
- Lower Limb Amputation: Monitor patients for infections or ulcers of lower limbs, and institute appropriate treatment
- Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., angioedema) have occurred with JARDIANCE. If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.
Contraindications
Situations in which the label states the medication must not be used.
- JARDIANCE is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred.
- Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.
Drug interactions
Interactions the label singles out.
- See Table 4 for clinically relevant interactions with JARDIANCE.
- See full prescribing information for information on drug interactions and interference of JARDIANCE with laboratory tests.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.
Generic or brand
There is no FDA-approved generic empagliflozin: the register of approved applications lists brand approvals only. The same ingredient also appears in combination products with metformin and with linagliptin, which are separate approvals with their own labels.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Jardiance is brand-only, and the acquisition cost below reflects that. Combination products that contain empagliflozin are priced separately and are not shown on this page. What a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per tablet, capsule or pen | Brand$11.20 (range $11.19 to $11.20, 204 listings) |
Median of 204 listings. Effective dates 2026-01-01 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is Jardiance only for diabetes?
- No. Its label carries four indications: improving glycemic control in type 2 diabetes in adults and children aged 10 and older, reducing cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, reducing cardiovascular death and hospitalization in adults with heart failure, and slowing kidney function decline in adults with chronic kidney disease at risk of progression. The heart failure and kidney indications do not require having diabetes.
- How is Jardiance different from Ozempic?
- Different classes working in different organs. Jardiance is an SGLT2 inhibitor: it acts in the kidney, making glucose leave with urine, and is a once-daily tablet. Ozempic is a GLP-1 receptor agonist: it works through gut hormone receptors and is a once-weekly injection. The comparison page sets the two labels side by side.
- Is Jardiance approved for weight loss?
- No. Weight reduction is not among the indications in the Jardiance label. Its approved uses are type 2 diabetes, cardiovascular risk in type 2 diabetes, heart failure and chronic kidney disease.
- Does Jardiance have a boxed warning?
- No. The Jardiance label carries no boxed warning. Its warnings section covers, among others, ketoacidosis, volume depletion and serious urinary tract and genital infections, and the full list from the label is on this page.
Other medications under type 2 diabetes
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Jardiance
Boehringer Ingelheim Pharmaceuticals, Inc.. Label version 31, effective 30 January 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.