Prescription medicine
Dapagliflozin Brand names: Farxiga
Dapagliflozin (Farxiga) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.184 per dapagliflozin 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dapagliflozin FDA label on DailyMed (effective June 3, 2026, AstraZeneca Pharmaceuticals LP); the NDA 202293 record on Drugs@FDA; every dapagliflozin label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFARXIGA (dapagliflozin) is indicated:
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.
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- January 8, 2014 Farxiga, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first April 6, 2026; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 22 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- October 1, 2041 Farxiga tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.184 per tablet Dapagliflozin 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 56,884 through July 30, 2026
What is dapagliflozin used for?
From the label: indications and usageFARXIGA (dapagliflozin) is indicated:
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. […]
Conditions named in the indications of dapagliflozin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (FARXIGA), AstraZeneca Pharmaceuticals LP, effective June 3, 2026 (SPL set 72ad22ae-efe6-4cd6-a302-98aaee423d69), via openFDA; the full label on DailyMed
What does the patient leaflet for dapagliflozin 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 FARXIGA?FARXIGA can cause serious side effects, including: • Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. FARXIGA 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. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: ∘ pain or tenderness ∘ swelling ∘ redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: ∘ Urinary tract infection: ▪ burning feeling when you urinate ▪ need to urinate often or right away ▪ pain in the lower part of your stomach (pelvis) ▪ blood in your urine You may also have a fever, back pain, nausea, or vomiting. ∘ Vaginal yeast infection: ▪ vaginal odor ▪ white or yellowish vaginal discharge (may be lumpy or look like cottage cheese) ▪ vaginal itching ∘ Yeast infection of the skin around the penis (balanitis or balanoposthitis): If you are uncircumcised, swelling may make it difficult to pull back the skin around the tip of your penis. […]
From the patient leaflet: How should I store FARXIGA?Store FARXIGA at room temperature between 68°F and 77°F (20°C and 25°C).
Source: FDA drug label (FARXIGA), AstraZeneca Pharmaceuticals LP, effective June 3, 2026 (SPL set 72ad22ae-efe6-4cd6-a302-98aaee423d69), via openFDA; the full label on DailyMed
Is there a generic for dapagliflozin (Farxiga)?
The FDA approved the first generic dapagliflozin on April 6, 2026. 15 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dapagliflozin from 22 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 17 patents for Farxiga tablets: the compound patent runs to December 16, 2029 (pediatric exclusivity to June 16, 2030), and the last listed entry to October 1, 2041. 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
- 2026 first generic approved
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dapagliflozin (Farxiga)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.184 per Dapagliflozin 10 mg tablet, down 98% from $11.51 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. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Dapagliflozin 5 mg tablet (generic)
- Farxiga 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dapagliflozin 10 mg tablet | Generic | $0.184 per tablet | $5.52 | -98% |
| Dapagliflozin 5 mg tablet | Generic | $0.163 per tablet | $4.88 | -99% |
| Farxiga 10 mg tablet | Brand | $12.08 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $362.31 | -37% |
| Farxiga 5 mg tablet | Brand | $12.08 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $362.27 | -37% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dapagliflozin label say about other medicines?
The dapagliflozin label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name dapagliflozin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bumetanide | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Bumetanide (1 mg); Dapagliflozin (Dose Regimen): 10 mg once daily for 7 days; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Digoxin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Digoxin (0.25 mg); Dapagliflozin (Dose Regimen): 20 mg loading dose then 10 mg once daily for 7 days; Effect on Coadministered Drug Exposure (% Change [90% CI]): ↔; ↔ |
| Glimepiride | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Glimepiride (4 mg); Dapagliflozin (Dose Regimen): 20 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Hydrochlorothiazide | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Hydrochlorothiazide (25 mg); Dapagliflozin (Dose Regimen): 50 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Lithium | drug interactions | Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during FARXIGA initiation and dosage changes. |
| Mefenamic acid | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Mefenamic Acid (loading dose of 500 mg followed by 14 doses of 250 mg every 6 hours); Dapagliflozin (Dose Regimen): 10 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↑13% [↑3%, ↑24%]; ↑51% [↑44%, ↑58%] |
| Metformin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Metformin (1000 mg); Dapagliflozin (Dose Regimen): 20 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Pioglitazone | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Pioglitazone (45 mg); Dapagliflozin (Dose Regimen): 50 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Rifampin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Rifampin (600 mg once daily for 6 days); Dapagliflozin (Dose Regimen): 10 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↓7% [↓22%, ↑11%]; ↓22% [↓27%, ↓17%] |
| Simvastatin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Simvastatin (40 mg); Dapagliflozin (Dose Regimen): 20 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Sitagliptin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Sitagliptin (100 mg); Dapagliflozin (Dose Regimen): 20 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↔; ↔ |
| Valsartan | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Valsartan (320 mg); Dapagliflozin (Dose Regimen): 20 mg; Effect on Dapagliflozin Exposure [% Change (90% CI)]: ↓12% [↓3%, ↓20%]; ↔ |
| Warfarin | drug interactions | Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.: Warfarin (25 mg); Dapagliflozin (Dose Regimen): 20 mg loading dose then 10 mg once daily for 7 days; Effect on Coadministered Drug Exposure (% Change [90% CI]): ↔; ↔ |
Source: FDA drug label (FARXIGA), AstraZeneca Pharmaceuticals LP, effective June 3, 2026 (SPL set 72ad22ae-efe6-4cd6-a302-98aaee423d69), via openFDA; the full label on DailyMed
What do FAERS reports show for dapagliflozin?
The FDA Adverse Event Reporting System holds 56,884 reports that list dapagliflozin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,831 are coded as a death and 16,246 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 rose sharply in 2025 (12,921, against a median of 1,725 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dapagliflozin?
9 other medicines are given the same way (oral) and in the same FDA class as dapagliflozin or labeled mainly for the same use (chronic kidney disease), the same class first. Chronic kidney disease lists all 8 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.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Empagliflozin | Heart failure, Type 2 diabetes, Chronic kidney disease | none listed | $11.19 per tablet 10 mg tablet | No current entry |
| Canagliflozin and metformin | Type 2 diabetes | none listed | $9.58 per tablet 150-1,000 mg tablet | No current entry |
| Empagliflozin and metformin | Type 2 diabetes | none listed | $5.60 per tablet 12.5-1,000 mg tablet | No current entry |
| Canagliflozin | Type 2 diabetes, Chronic kidney disease | none listed | $19.13 per tablet 100 mg tablet | No current entry |
| Empagliflozin and linagliptin and metformin | Type 2 diabetes | none listed | $11.28 per tablet 10-5-1,000 mg tablet | No current entry |
| Bexagliflozin | Type 2 diabetes | none listed | n/a | No current entry |
| Empagliflozin and linagliptin | Type 2 diabetes | none listed | $11.24 per tablet 10 mg-5 mg tablet | No current entry |
| Sotagliflozin | Heart failure | none listed | $20.37 per tablet 200 mg tablet | No current entry |
Every medicine labeled for the same conditions as dapagliflozin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dapagliflozin compare with medicines for the same use?
5 side-by-side pages set dapagliflozin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dapagliflozin
- 9 medicines for the same use
- Other SGLT2 inhibitors
- the pharmacologic class, with prices and generics
- Dapagliflozin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other