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Dapagliflozin

Dapagliflozin is an SGLT2 inhibitor tablet used to treat type 2 diabetes, heart failure, and chronic kidney disease.

Brand name Farxiga
Drug class Sodium-glucose Cotransporter 2 Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 29 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 4, 2026
Dapagliflozin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Dapagliflozin (Farxiga) makes the kidneys flush extra sugar and salt into the urine, which lowers blood sugar in type 2 diabetes and eases strain on the heart and kidneys, so this once-daily drug, around for more than a decade and available as a generic, is now a mainstay for heart failure and chronic kidney disease too. Most people tolerate it well, noticing more trips to the bathroom and, for some, genital yeast infections. Watch for diabetic ketoacidosis, a dangerous acid buildup in the blood, so nausea, vomiting, stomach pain or trouble breathing means stopping it and getting emergency care, even if your blood sugar reads normal.

Clinical pearls

  • Tell your surgeon about it, since your doctor may pause it at least 3 days before any procedure that requires fasting.
  • Drink enough fluids, especially if you are older or take a water pill, since it can cause dehydration and dizziness.
  • Urine sugar test strips and the 1,5-AG blood test become unreliable on this drug, so track blood sugar another way.
  • Groin pain, redness or swelling with fever needs same-day care, since it can signal a rare, serious infection called Fournier's gangrene.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2008
Companies listing it with the FDA24
FDA label last updatedJun 3, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Dapagliflozin, written from its FDA label.

What Dapagliflozin is used for

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Dapagliflozin is an SGLT2 inhibitor tablet approved for several distinct conditions across its supported products.

  • Improves blood sugar control in adults with type 2 diabetes (alongside diet and exercise) — both Farxiga and dapagliflozin tablets
  • Farxiga is also approved for this use in children aged 10 and older with type 2 diabetes
  • Reduces the risk of hospitalization for heart failure in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors — both Farxiga and dapagliflozin tablets
  • Farxiga reduces the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure (regardless of diabetes status)
  • Farxiga reduces the risk of sustained kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
  • Not approved to improve blood sugar control in type 1 diabetes
  • Not recommended for blood sugar control when kidney function (eGFR) is below 45 mL/min/1.73 m² — likely to be ineffective
  • Farxiga is not recommended for chronic kidney disease in patients with polycystic kidney disease or those on immunosuppressive therapy for kidney disease

How Dapagliflozin works

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Dapagliflozin blocks a protein called SGLT2 (sodium-glucose cotransporter 2) found in the kidneys' filtering tubes. Normally, SGLT2 pulls glucose back into the bloodstream after it has been filtered. By blocking SGLT2, dapagliflozin lets excess glucose pass out of the body in the urine, lowering blood sugar levels. It also reduces how much sodium the kidney reabsorbs, which decreases fluid load on the heart, lowers pressure inside the kidney's tiny filtering units, and dials down overactive nerve signals that can stress the cardiovascular system.

Dapagliflozin dosage

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Dapagliflozin tablets are taken once daily by mouth and can be taken with or without food — even a high-fat meal does not meaningfully change how much drug is absorbed. The dose your doctor prescribes will depend on your specific condition; the starting dose for blood sugar control is lower, and may be increased if more control is needed, while the dose used for heart failure and kidney disease indications is typically fixed. Before starting, your doctor will assess your kidney function and hydration status.

  • Withhold for at least 3 days before surgery or a procedure requiring prolonged fasting, if possible; restart once you are stable and eating again
  • Dose adjustments may be needed based on kidney function — follow your prescriber's guidance

Dosing details from the FDA-approved label

From the Dapagliflozin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus
    • Recommended starting dosage is 5 mg orally once daily
    • For additional glycemic control, the dosage can be increased to 10 mg orally once daily
    • eGFR greater than or equal to 45 mL/min/1.73 m2: same as normal renal function; not recommended for glycemic control if eGFR less than 45 mL/min/1.73 m2
  • Chronic kidney disease at risk of progression (to reduce the risk of sustained eGFR decline, ESKD, CV death, and hHF) in adults
    • 10 mg orally once daily
    • eGFR 25 or above: same as normal renal function; initiation not recommended if eGFR less than 25, but patients may continue 10 mg once daily if eGFR falls below 25 mL/min/1.73 m2 during treatment
  • Heart failure in adults (to reduce the risk of CV death, hHF, and urgent heart failure visit)
    • 10 mg orally once daily
    • eGFR 25 or above: same as normal renal function; initiation not recommended if eGFR less than 25 mL/min/1.73 m2
  • Type 2 diabetes mellitus with established CV disease or multiple CV risk factors (to reduce the risk of hHF) in adults
    • 10 mg orally once daily
    • eGFR 25 or above: same as normal renal function; initiation not recommended if eGFR less than 25 mL/min/1.73 m2
  • Surgery or procedures associated with prolonged fasting
    • Withhold for at least 3 days, if possible, prior to surgery or procedure
    • Resume when the patient is clinically stable and has resumed oral intake
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. (2.1) • 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. (2.2) • For all other indications, the recommended dosage is 10 mg orally once daily. (2.3) • See full prescribing information for dosage recommendations in patients with renal impairment. ( 2.2 , 2.3 ) • Withhold DAPAGLIFLOZIN TABLETS for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. (2.4) 2.1 Testing Prior to Initiation of DAPAGLIFLOZIN TABLETS • Assess renal function prior to initiation of DAPAGLIFLOZIN TABLETS and then as clinically indicated [see Warnings and Precautions (5.2) ]. • Assess volume status. In patients with volume depletion, correct this condition before initiating DAPAGLIFLOZIN TABLETS [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ] . 2.2 Recommended Dosage for Glycemic Control in Adults and Pediatric Patients Aged 10 Years and Older with Type 2 Diabetes Mellitus In adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, the recommended starting dosage of DAPAGLIFLOZIN TABLETS is 5 mg orally once daily to improve glycemic control. For additional glycemic control, the dosage can be increased to 10 mg orally once daily. For Adult and Pediatric Patients with Type 2 Diabetes Mellitus and Renal Impairment: • The recommended dosage for DAPAGLIFLOZIN TABLETS in patients with an eGFR greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. • DAPAGLIFLOZIN TABLETS are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . DAPAGLIFLOZIN TABLETS are likely to be ineffective to improve glycemic control in this setting based upon its mechanism of action.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Dapagliflozin side effects

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The most common side effects reported in clinical trials include:

Common side effects

  • Genital yeast infections (in both women and men)
  • Urinary tract infections
  • Nasopharyngitis (runny nose, sore throat)
  • Increased urination
  • Back pain
  • Nausea
  • Discomfort with urination
  • Symptoms of dehydration such as dizziness or low blood pressure

When to get medical help

  • Signs of diabetic ketoacidosis (a dangerous buildup of acids in the blood): nausea, vomiting, stomach pain, tiredness, or trouble breathing — seek emergency care immediately, even if blood sugar seems normal
  • Signs of a serious urinary tract infection spreading to the kidneys (urosepsis or pyelonephritis): fever, chills, pain in your back or side — get medical help right away
  • Pain, redness, swelling, or tenderness in the genital or perineal (groin) area, especially with fever or feeling very unwell — this could be a rare but life-threatening skin infection called Fournier's gangrene
  • Signs of low blood pressure or dehydration: dizziness, lightheadedness, feeling faint — call your doctor
  • Signs of low blood sugar (hypoglycemia) if also taking insulin or a sulfonylurea: shaking, sweating, confusion, rapid heartbeat — treat and call your doctor

More serious reactions — including diabetic ketoacidosis, severe urinary tract infections spreading to the kidneys, and a rare but life-threatening skin infection near the genitals (Fournier's gangrene) — require immediate medical attention if any warning signs appear.

Dapagliflozin warnings and precautions

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  • Diabetic ketoacidosis (DKA): A dangerous acid buildup in the blood that can be life-threatening. Risk is markedly higher in type 1 diabetes (which is why it's not approved for that use), but it can also occur in type 2 diabetes. Blood sugar may not be very high when DKA occurs. Symptoms: nausea, vomiting, stomach pain, fatigue, shortness of breath. Stop the medication and seek emergency care immediately.
  • Dehydration and low blood pressure: Dapagliflozin causes the kidneys to excrete more fluid. Elderly patients, those with kidney problems, and people on diuretics are most at risk. Signs include dizziness, lightheadedness, and fainting.
  • Serious urinary tract infections: Including infections spreading to the kidneys (pyelonephritis) or into the bloodstream (urosepsis), which can require hospitalization. Report fever, back or side pain, or chills promptly.
  • Fournier's gangrene: A rare but life-threatening bacterial infection of the tissue around the genitals or perineum. Seek emergency care for pain, redness, swelling, or fever in that area.
  • Low blood sugar (hypoglycemia): Risk increases when combined with insulin or sulfonylurea medications. Your doctor may lower those doses.
  • Genital yeast infections: More likely in people with a prior history of such infections. Treatable if they occur.

Dapagliflozin interactions

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Tell your doctor and pharmacist about all medications you take. Key interactions include:

  • Insulin and insulin secretagogues (e.g., sulfonylureas): Combining these with dapagliflozin raises the risk of low blood sugar — dose reductions of those agents may be needed
  • Lithium: Dapagliflozin can lower lithium levels in the blood — more frequent monitoring of lithium levels is recommended when starting or adjusting dapagliflozin
  • Urine glucose tests: Dapagliflozin causes glucose to appear in the urine, making these tests unreliable for tracking blood sugar control — use blood-based monitoring instead
  • 1,5-AG blood test: This glycemic control test is also unreliable in people taking SGLT2 inhibitors like dapagliflozin — your doctor should use alternative lab tests

Interactions listed in the FDA-approved label

From the Dapagliflozin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Insulin or insulin secretagogues (e.g., sulfonylurea): The risk of hypoglycemia may be increased when used concomitantly. Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia.
  • Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during initiation and dosage changes.
  • Positive urine glucose test: SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Monitoring glycemic control with urine glucose tests is not recommended; use alternative methods.
  • 1,5-anhydroglucitol (1,5-AG) assay: Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Monitoring glycemic control with 1,5-AG assay is not recommended; use alternative methods.
  • Rifampin (600 mg once daily for 6 days): Dapagliflozin Cmax decreased 7% and AUC decreased 22%. No dosing adjustments required.
  • Mefenamic acid: Dapagliflozin Cmax increased 13% and AUC increased 51%. No dose adjustments are recommended for dapagliflozin.
  • Metformin, pioglitazone, sitagliptin, glimepiride: No meaningful change in dapagliflozin exposure, and dapagliflozin did not meaningfully affect their pharmacokinetics. No dosing adjustments required.
  • Hydrochlorothiazide, bumetanide, valsartan, simvastatin: No meaningful effect on dapagliflozin exposure and no meaningful effect of dapagliflozin on these drugs. No dosing adjustments required.
  • Digoxin and warfarin: Dapagliflozin did not meaningfully change their exposure. No dosing adjustments required.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 4: Clinically Relevant Interactions with DAPAGLIFLOZIN TABLETS Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when DAPAGLIFLOZIN TABLETS are used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.4) ] . Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during DAPAGLIFLOZIN TABLETS initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Intervention Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. • See full prescribing information for information on drug interactions and interference of DAPAGLIFLOZIN TABLETS with laboratory tests. (7)

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.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿256 supplements and herbs with documented Dapagliflozin interactions, ranked by severity Check Dapagliflozin against a supplement or herb →

Before taking Dapagliflozin

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  • Do not take if you have had a serious allergic reaction (such as anaphylaxis or severe swelling) to dapagliflozin in the past — this is a contraindication
  • Not recommended during the second and third trimesters of pregnancy — animal studies showed kidney development problems in the fetus; discuss with your doctor if you are pregnant or planning to become pregnant
  • Not recommended while breastfeeding — potential risk to the developing infant's kidneys; advise your doctor
  • Not for use in type 1 diabetes for blood sugar control — significantly increases the risk of DKA in this group
  • Not recommended in children under 10 years old; safety and effectiveness not established in this age group for blood sugar control
  • Older adults (65 and older): higher risk of low blood pressure — monitor carefully, especially when starting the medication
  • Kidney impairment: higher risk of dehydration and low blood pressure — your doctor will check kidney function before and during treatment and may adjust your dose
  • Polycystic kidney disease or recent immunosuppressive therapy for kidney disease: Farxiga is not expected to be effective and is not recommended for chronic kidney disease in these patients
  • Severe liver disease: drug exposure may be higher — inform your doctor

Dapagliflozin overdose

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No overdose cases were reported during clinical trials of dapagliflozin. If you think you or someone else has taken too much, call the Poison Help line at 1-800-222-1222 or seek immediate medical attention. Supportive care will be guided by the patient's condition; it is not known whether hemodialysis can remove dapagliflozin from the body.

What Dapagliflozin does in the body

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After taking dapagliflozin, the kidneys excrete significantly more glucose in the urine — studies in people with type 2 diabetes showed roughly 70 grams of glucose excreted per day after several weeks of treatment. This extra urinary glucose also increases urine volume. If dapagliflozin is stopped, urinary glucose excretion returns toward normal within about 3 days (for the standard dose), though in some post-marketing cases, elevated glucose and ketone excretion have persisted longer after stopping. Dapagliflozin does not appear to affect the heart's electrical rhythm at standard or even much higher doses.

How your body processes Dapagliflozin

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After taking dapagliflozin by mouth, peak blood levels are reached within about 2 hours on an empty stomach; food slows absorption slightly but does not meaningfully change the total amount absorbed. The drug is about 91% bound to proteins in the blood and is broken down mainly in the liver into an inactive byproduct. Dapagliflozin and its metabolites are cleared primarily through the urine, and the drug's half-life (the time it takes for half the drug to leave the body) is approximately 13 hours, supporting once-daily dosing. In people with moderate or severe kidney impairment, blood levels of dapagliflozin are higher, though the blood sugar-lowering effect is reduced because the kidneys are less able to excrete glucose.

How to store Dapagliflozin

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

256

Supplements & herbs that interact with Dapagliflozin

256 supplements and herbal products have documented interactions with Dapagliflozin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 215
  • Minor · 39
ACTIVATED CHARCOAL Major SIBERIAN COCKLEBUR Major ACAI Moderate AFRICAN WILD POTATO Moderate AGARICUS MUSHROOM Moderate AGMATINE Moderate AGRIMONY Moderate ALFALFA Moderate +248 more
Every supplement checked against Dapagliflozin — ranked by severity The full interaction hub: 2 major · 215 moderate · 39 minor · every one linked to its full report. Check Dapagliflozin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Dapagliflozin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insignificant Depletion
See the full Dapagliflozin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Dapagliflozin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Dapagliflozin — the kind of thing our pharmacy team would talk through with you at the counter.

What is dapagliflozin actually used for — is it just for diabetes?

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No, it's used for more than just blood sugar control. Dapagliflozin is approved to help manage type 2 diabetes, but it's also used to reduce the risk of serious heart failure complications and to slow the progression of chronic kidney disease in adults at risk. Farxiga, specifically, covers all three of these areas. So depending on what your doctor has prescribed it for, you might be taking it even if diabetes isn't your main concern.

Can I take this tablet with food, or does it have to be on an empty stomach?

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You can take it either way — with or without food. A high-fat meal may slow how quickly it absorbs slightly, but it doesn't change the overall amount that gets into your system. Just try to take it at roughly the same time each day as your doctor advises. Consistency is more important than whether you've eaten.

What side effects are most likely, and which ones mean I should call my doctor right away?

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The most common side effects are genital yeast infections, urinary tract infections, and a runny nose or sore throat. You may also urinate more often, which is normal since the drug works through the kidneys. However, you should call your doctor or seek emergency care if you have nausea, vomiting, stomach pain, or trouble breathing — even if your blood sugar seems okay — because these could be signs of a serious condition called diabetic ketoacidosis. Also get help right away if you notice pain, redness, or swelling in the genital area along with fever.

I also take insulin. Do I need to worry about low blood sugar?

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Yes, that's an important one to know about. When you take dapagliflozin together with insulin or certain diabetes pills called sulfonylureas, the risk of low blood sugar goes up. Your doctor may lower the dose of your insulin or other diabetes medication to compensate. Watch for symptoms like shakiness, sweating, confusion, or a fast heartbeat, and treat low blood sugar as you've been instructed.

Is it safe to take this medication if I'm pregnant or breastfeeding?

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It's not recommended during the second and third trimesters of pregnancy, because animal studies showed it can affect kidney development in the fetus. If you find out you're pregnant while taking dapagliflozin, let your doctor know right away so they can review your options. For breastfeeding, it's also not recommended — there's a potential risk to the baby's developing kidneys. Talk to your doctor about safe alternatives.

Do I need to stop taking this before surgery?

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Yes, your doctor will likely ask you to stop dapagliflozin at least 3 days before a surgery or procedure that requires you to stop eating or drinking for a prolonged period. This is because fasting combined with this medication can increase the risk of a serious acid buildup in the blood called ketoacidosis. You can restart it once you're medically stable and eating normally again — but always confirm the timing with your surgeon and prescriber.

Is Dapagliflozin available over the counter?

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No. Dapagliflozin is a prescription medicine: every Dapagliflozin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Dapagliflozin first available?

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The earliest FDA record we hold for Dapagliflozin is from 2008: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Dapagliflozin was first used.

Who makes Dapagliflozin?

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24 companies currently list Dapagliflozin products in the FDA's NDC Directory, including A-S Medication Solutions, ANI Pharmaceuticals, Inc., Ajanta Pharma USA Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Dapagliflozin on HelloPharmacist

📊Dapagliflozin supplement interactions256 checked — ranked by severity 🌿Drug & Supplement CheckerDapagliflozin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Dapagliflozin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Dapagliflozin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Dapagliflozin forms and strengths (how it comes)

Dapagliflozin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Farxiga
How this form is used
What it may be used for
  • Farxiga is approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure
  • Farxiga is approved to reduce the risk of kidney disease progression, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of getting worse
  • Both Farxiga and dapagliflozin tablets are approved to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors
  • Both Farxiga and dapagliflozin tablets are approved to improve blood sugar control in adults with type 2 diabetes alongside diet and exercise; Farxiga also covers children aged 10 and older
Important instructions
  • Take one tablet by mouth once daily, with or without food
  • Farxiga and dapagliflozin tablets: withhold for at least 3 days before surgery or procedures that require prolonged fasting, if possible; resume when clinically stable and eating again
  • Your doctor will check your kidney function and hydration status before you start
  • Follow your prescriber's instructions for your specific dose — dosing differs depending on whether it is being used for blood sugar control or for heart failure and kidney disease
Available strengths 2 strengths
5 mg 10 mg
109 FDA-listed product records ⓘ

Dapagliflozin on the U.S. market: products, makers and brands

How Dapagliflozin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

24 companies list 50 Dapagliflozin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2008. Brand names on the directory include Farxiga; the rest are generics.

1
Dose forms ⓘ
24
Labelers (makers, repackagers, distributors)
2
Brand names
50
FDA-listed product records ⓘ
2008
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (40) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions12%
ANI Pharmaceuticals, Inc.4%
Ajanta Pharma USA Inc.4%
Alembic Pharmaceuticals Inc.4%
Alembic Pharmaceuticals Limited4%
Apotex Corp.4%
Other makers68%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Dapagliflozin is used (Medicaid data)

A general measure of how commonly Dapagliflozin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dapagliflozin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,339,664
Medicaid prescriptions filled (Q1–Q4 2025)
$993.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dapagliflozin prescribed? Of the 1,601 medications we measure, Dapagliflozin ranks #140 by Medicaid prescriptions — more than 91% of them.

Where Dapagliflozin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #140 of 1,601
#135 Buprenorphine 1,379,027 Rx #136 Chlorhexidine 1,373,852 Rx #137 Simvastatin 1,357,663 Rx #138 Tretinoin 1,345,058 Rx #139 Tretinoin Topical 1,344,781 Rx #140 Dapagliflozin 1,339,664 Rx #141 Benztropine 1,314,428 Rx #142 Diphenhydramine 1,303,409 Rx #143 Dexamethasone Injectio... 1,290,031 Rx #144 Ketorolac Injection 1,259,288 Rx #145 Dicyclomine 1,233,412 Rx

Utilization by Dapagliflozin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Dapagliflozin product — about 82% of these Medicaid prescriptions.

dapagliflozin 10 MG Oral Tablet Most dispensed

1,099,770 Medicaid prescriptions (Q1–Q4 2025) 82% of Dapagliflozin prescriptions shown $818.3M gross reimbursement (before rebates) ≈ $744 per prescription (gross)

Summed across the 4 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488569

dapagliflozin 5 MG Oral Tablet

239,894 Medicaid prescriptions (Q1–Q4 2025) 18% of Dapagliflozin prescriptions shown $175.4M gross reimbursement (before rebates) ≈ $731 per prescription (gross)

Summed across the 3 of 56 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1488574

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dapagliflozin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 112 listed Dapagliflozin NDCs with Medicaid activity.

Compare Dapagliflozin products

A representative set of FDA-listed product records for Dapagliflozin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 50 of 50 products — FDA National Drug Code Directory. See every product, package size and price: browse all 50 Dapagliflozin NDCs →

Dapagliflozin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Dapagliflozin recalls since July 2021.

✅No Dapagliflozin recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Dapagliflozin RxCUI 1488564 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1488568 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1488574 10 MG RxCUI 1488569

Look up RxCUI 1488564 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Dapagliflozin brand names

Dapagliflozin is sold under one brand name in the FDA directory — Farxiga. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Farxiga

Who makes Dapagliflozin: manufacturers and labelers

24 companies list Dapagliflozin products with the FDA. By number of product records, the largest are A-S Medication Solutions, ANI Pharmaceuticals, Inc., Ajanta Pharma USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 6 ANI Pharmaceuticals, Inc. 2 Ajanta Pharma USA Inc. 2 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Apotex Corp. 2 Ascend Laboratories, LLC 2 AstraZeneca Pharmaceuticals LP 2 Aurobindo Pharma Limited 2 AvKARE 2 Biocon Pharma Inc. 2 Bryant Ranch Prepack 2 Cipla USA Inc. 2 Florida Pharmaceutical Products, LLC 2 Lupin Pharmaceuticals, Inc. 2 Macleods Pharmaceuticals Limited 2 Novadoz Pharmaceuticals LLC 2 Prasco Laboratories 2 Sandoz Inc 2 Teva Pharmaceuticals, Inc. 2 Zydus Lifesciences Limited 2 Zydus Pharmaceuticals USA Inc. 2 Remedyrepack Inc. 1 Redpharm Drug 1

Dapagliflozin drug class (RxNorm)

Dapagliflozin belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works Sodium-Glucose Transporter 2 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Dapagliflozin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dapagliflozin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dapagliflozin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
29
Finished products in the current FDA directory
50
Companies listing them (makers, repackagers, distributors)
24
FDA labeler codes behind them ⓘ
25
Linked representative label ⓘ
Prasco Laboratories
Linked label effective
Jun 3, 2026
Composite sections available
22
Linked SPL Set ID
3aba33aa-f8c6-4b10-85c8-dfa14578d07c
Linked SPL Document ID
b54f524c-1dad-4ae5-bf78-844d930ff680
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Prasco Laboratories is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →