Type 2 diabetesActive ingredient
Dapagliflozin
SGLT2 inhibitor1 FDA label read
Dapagliflozin is sold as Farxiga and, unlike its closest neighbour Jardiance, already has FDA-approved generics. The label covers type 2 diabetes in adults and children aged 10 and older, heart failure, and chronic kidney disease - and, as with Jardiance, the heart and kidney indications stand on their own, without requiring diabetes.
Highlights of the labels
- Farxiga
- Type 2 diabetes, heart failure, chronic kidney diseasecovers type 2 diabetes
- Supply
- Prescription only
- Generic
- 21 approved applications
- 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 |
|---|---|---|---|
| FarxigaAstraZeneca Pharmaceuticals LP | What its label approvesType 2 diabetes, heart failure, chronic kidney diseaseCovers type 2 diabetes | SupplyPrescription | Label version3 June 2026 |
How it works
Dapagliflozin inhibits SGLT2, the transporter responsible for most of the reabsorption of filtered glucose in the kidney. Blocking it sends more glucose out with urine and lowers blood glucose independently of insulin.
Mechanism of action, Farxiga label
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion.
What the FDA approved it for
The approved uses, as worded in the label.
- To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
- To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
- To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.
- 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.
- Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.
- Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. FARXIGA is not expected to be effective in these populations.
Forms and strengths
The presentations and strengths listed in the label.
Tablets: 5 mg and 10 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 prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating.
- To improve glycemic control, the recommended starting dosage is 5 mg orally once daily. Dosage can be increased to 10 mg orally once daily for additional glycemic control.
- For all other indications, the recommended dosage is 10 mg orally once daily.
- See full prescribing information for dosage recommendations in patients with renal impairment.
- Withhold FARXIGA for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Testing Prior to Initiation of FARXIGA
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.
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 FARXIGA if ketoacidosis is suspected.
- Volume depletion: Before initiating FARXIGA, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on 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: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA. Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, FARXIGA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate.
Contraindications
Situations in which the label states the medication must not be used.
History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA.
Drug interactions
Interactions the label singles out.
- • See full prescribing information for information on drug interactions and interference of FARXIGA with laboratory tests.
- Drug Interactions In Vitro Assessment of Drug Interactions In in vitro studies, dapagliflozin and dapagliflozin 3-O-glucuronide neither inhibited CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4.
- Dapagliflozin is a weak substrate of the P-glycoprotein (P-gp) active transporter, and dapagliflozin 3-O-glucuronide is a substrate for the OAT3 active transporter.
- Dapagliflozin or dapagliflozin 3-O-glucuronide did not meaningfully inhibit P-gp, OCT2, OAT1, or OAT3 active transporters.
- Overall, dapagliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are P-gp, OCT2, OAT1, or OAT3 substrates.
- Effects of Other Drugs on Dapagliflozin Table 5 shows the effect of coadministered drugs on the pharmacokinetics of dapagliflozin in adults.
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, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see clinical considerations).
Generic or brand
Generic dapagliflozin is FDA-approved: the register lists 21 approved generic applications for this ingredient. Combination products with metformin and with saxagliptin are separate approvals and separate documents.
The FDA label database lists 21 approved generic applications for this ingredient.
What affects the cost
With approved generics on the register, the gap between the brand price and the generic price is the practical story of this ingredient, and the table below shows both where the pricing data lists them. 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 | Generic |
|---|---|---|
| per tablet, capsule or pen | Brand$12.08 (range $12.07 to $19.17, 170 listings) | Generic$0.205 (range $0.184 to $11.50, 587 listings) |
Median of 757 listings. Effective dates 2025-12-17 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
- What is the difference between Farxiga and Jardiance?
- Both are SGLT2 inhibitors with labels covering type 2 diabetes, heart failure and chronic kidney disease, and the two documents read closely in parallel. The differences sit in the details of each indication's wording, in dosing, and in supply: dapagliflozin has FDA-approved generics while empagliflozin does not. The comparison page reads both labels line by line.
- Is there a generic Farxiga?
- Yes. The FDA register lists 21 approved generic applications for dapagliflozin. The brand and generic figures in the pricing table on this page show what that does to acquisition cost.
- Is Farxiga approved for weight loss?
- No. Weight reduction does not appear among the indications in the Farxiga label. Its approved uses are type 2 diabetes, heart failure and chronic kidney disease.
- Does Farxiga have a boxed warning?
- No. The label carries no boxed warning. Its warnings cover ketoacidosis, volume depletion, urinary tract and genital infections among others, quoted on this page from the label itself.
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 Farxiga
AstraZeneca Pharmaceuticals LP. Label version 47, effective 3 June 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.