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Prescription medicine

Empagliflozin Brand names: Jardiance

Empagliflozin (Jardiance) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $11.19 per Jardiance 10 mg tablet in the October 7, 2026 NADAC survey.

  • No generic listed

Check it at the source: the empagliflozin FDA label on DailyMed (effective January 30, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 204629 record on Drugs@FDA; every empagliflozin label on DailyMed.

Highlights of the record

FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

Forms and strengths

  • 10 mg
  • 25 mg

Film-coated tablet.

On the market

Earliest approval on file
August 1, 2014 Jardiance, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
2 first August 3, 2022; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC)
5 of which 0 under generic applications, 5 under brand applications, repackagers included
Last listed patent
December 11, 2034 Jardiance tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$11.19 per tablet Jardiance 10 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
2 since 2022 0 Class I among all firms' recalls; latest March 9, 2023
FAERS reports
66,937 through July 30, 2026

What is empagliflozin used for?

From the label: indications and usage

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. 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. […]

Conditions named in the indications of empagliflozin's FDA labels, with every medicine labeled for each:

From other empagliflozin labels

Type 2 diabetes: … at risk of progression. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. …

FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.

Source: FDA drug label (Jardiance), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 30, 2026 (SPL set faf3dd6a-9cd0-39c2-0d2e-232cb3f67565), via openFDA; the full label on DailyMed

What does the patient leaflet for empagliflozin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about JARDIANCE?

JARDIANCE can cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. JARDIANCE can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking JARDIANCE and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing ketones in your urine or blood Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking JARDIANCE. […]

From the patient leaflet: How should I store JARDIANCE?

Store JARDIANCE at room temperature between 68°F to 77°F (20°C to 25°C). Keep JARDIANCE and all medicines out of the reach of children.

Source: FDA drug label (Jardiance), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 30, 2026 (SPL set faf3dd6a-9cd0-39c2-0d2e-232cb3f67565), via openFDA; the full label on DailyMed

Is there a generic for empagliflozin (Jardiance)?

The FDA approved the first generic empagliflozin on August 3, 2022. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 8 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

The Orange Book lists 15 patents for Jardiance tablets: the compound patent runs to August 1, 2028 (pediatric exclusivity to February 1, 2029), and the last listed entry to December 11, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2014 earliest approval on file
  • 2022 first generic approved
  • 2034 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for empagliflozin (Jardiance)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.19 per Jardiance 10 mg tablet, down 44% from $20.13 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Jardiance 10 mg tablet (brand)
$20.13
$11.19
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Jardiance 10 mg tabletBrand$11.19 per tablet$335.68-44%
Jardiance 25 mg tabletBrand$11.19 per tablet$335.69-44%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has empagliflozin been recalled?

The FDA's Enforcement Report lists 2 recalls naming empagliflozin since 2022: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
March 9, 2023Class IIBoehringer Ingelheim Pharmaceuticals, Inc.Labeling: Label Mix-up
January 26, 2022Class IICARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the empagliflozin label say about other medicines?

The empagliflozin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name empagliflozin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Lithiumdrug interactionsLithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during JARDIANCE initiation and dosage changes.

Check empagliflozin against other medicines

Source: FDA drug label (Jardiance), Boehringer Ingelheim Pharmaceuticals, Inc., effective January 30, 2026 (SPL set faf3dd6a-9cd0-39c2-0d2e-232cb3f67565), via openFDA; the full label on DailyMed

What do FAERS reports show for empagliflozin?

The FDA Adverse Event Reporting System holds 66,937 reports that list empagliflozin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,360 are coded as a death and 22,129 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Diabetic Ketoacidosis (named in the label)3,864
  • Nausea (named in the label)3,572
  • Diarrhoea3,239
  • Blood Glucose Increased3,197
  • Weight Decreased2,922
  • Fatigue2,884
  • Off Label Use (a use or a product term, not a reaction)2,787
  • Vomiting (named in the label)2,693

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as empagliflozin?

22 other medicines are given the same way (oral) and in the same FDA class as empagliflozin or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
DapagliflozinHeart failure, Type 2 diabetes, Chronic kidney disease22 labelers$0.184 per tablet 10 mg tabletNo current entry
Dapagliflozin and metforminHeart failure, Type 2 diabetes8 labelers$0.720 per tablet 10-1,000 mg tabletNo current entry
Canagliflozin and metforminType 2 diabetesnone listed$9.58 per tablet 150-1,000 mg tabletNo current entry
CanagliflozinType 2 diabetes, Chronic kidney diseasenone listed$19.13 per tablet 100 mg tabletNo current entry
BexagliflozinType 2 diabetesnone listedn/aNo current entry
SotagliflozinHeart failurenone listed$20.37 per tablet 200 mg tabletNo current entry
Dapagliflozin and saxagliptinType 2 diabetes1 labelern/aNo current entry
CarvedilolHeart failure41 labelers$0.0179 per tablet 6.25 mg tabletNo current entry

Every medicine labeled for the same conditions as empagliflozin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does empagliflozin compare with medicines for the same use?

5 side-by-side pages set empagliflozin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to empagliflozin
22 medicines for the same use
Other SGLT2 inhibitors
the pharmacologic class, with prices and generics
Empagliflozin side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other