Prescription medicine
Dapagliflozin and metformin Brand names: Xigduo; first approved as Xigduo Xr
Dapagliflozin and metformin (Xigduo) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $0.720 per dapagliflozin-metformin ER 10-1,000 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $9.59 per Xigduo XR 5 mg-1,000 mg tablet.
- Generic listed
- Boxed warning
Check it at the source: the dapagliflozin and metformin FDA label on DailyMed (effective August 11, 2026, AstraZeneca Pharmaceuticals LP); the NDA 205649 record on Drugs@FDA; every dapagliflozin and metformin label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS •.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by non‑specific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ].
Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment and mitochondrial diseases [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageXIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated 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.
Forms and strengths
- 2.5 mg / 1000 mg
- 5 mg / 1000 mg
- 5 mg / 500 mg
- 10 mg / 500 mg
- 10 mg / 1000 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- October 29, 2014 Xigduo Xr, Astrazeneca Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first April 6, 2026; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 8 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 12, 2031 Xigduo XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.720 per tablet Dapagliflozin-metformin ER 10-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 3,402 through July 30, 2026
What is dapagliflozin and metformin used for?
From the label: indications and usageXIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated 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. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
Sustained eGFR decline, end‑stage kidney disease, (CV) death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.
CV death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. […]
Conditions named in the indications of dapagliflozin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (XIGDUO XR), AstraZeneca Pharmaceuticals LP, effective August 11, 2026 (SPL set ac8a0f7b-9f69-4495-abbc-3a47cd75a859), via openFDA; the full label on DailyMed
What does the patient leaflet for dapagliflozin and metformin 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 XIGDUO XR?XIGDUO XR can cause serious side effects, including: • Lactic Acidosis. Metformin, one of the medicines in XIGDUO XR, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis: ∘ you feel cold in your hands or feet ∘ you have unusual (not normal) muscle pain ∘ you feel dizzy or lightheaded ∘ you have trouble breathing ∘ you have a slow or irregular heartbeat ∘ you feel unusual sleepiness or sleep longer than usual ∘ you feel very weak or tired ∘ you have stomach pains, nausea or vomiting Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. […] 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: What should I avoid while taking XIGDUO XR?Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store XIGDUO XR?Store XIGDUO XR at room temperature between 68°F and 77°F (20°C and 25°C). Keep XIGDUO XR and all medicines out of the reach of children.
Source: FDA drug label (XIGDUO XR), AstraZeneca Pharmaceuticals LP, effective August 11, 2026 (SPL set ac8a0f7b-9f69-4495-abbc-3a47cd75a859), via openFDA; the full label on DailyMed
Is there a generic for dapagliflozin and metformin (Xigduo)?
The FDA approved the first generic dapagliflozin and metformin on April 6, 2026. 10 generic applications are approved; 10 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dapagliflozin and metformin from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Xigduo XR tablets: the compound patent runs to December 16, 2029 (pediatric exclusivity to June 16, 2030), and the last listed entry to May 12, 2031. 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
- 2031 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 dapagliflozin and metformin (Xigduo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.720 per Dapagliflozin-metformin ER 10-1,000 mg tablet, down 94% from $11.86 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-metformin ER 5-1,000 mg tablet (generic)
- Xigduo XR 5 mg-1,000 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dapagliflozin-metformin ER 10-1,000 mg tablet | Generic | $0.720 per tablet | $21.59 | -94% |
| Dapagliflozin-metformin ER 10-500 mg tablet | Generic | $0.802 per tablet | $24.06 | n/a |
| Dapagliflozin-metformin ER 5-1,000 mg tablet | Generic | $0.461 per tablet | $13.82 | -92% |
| Dapagliflozin-metformin ER 5-500 mg tablet | Generic | $0.707 per tablet | $21.22 | n/a |
| Xigduo XR 10 mg-1,000 mg tablet | Brand | $19.20 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $576.13 | +0.2% |
| Xigduo XR 10 mg-500 mg tablet | Brand | $19.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $577.17 | +0.1% |
| Xigduo XR 2.5 mg-1,000 mg tablet | Brand | $9.61 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $288.25 | no change |
| Xigduo XR 5 mg-1,000 mg tablet | Brand | $9.59 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $287.77 | +0.1% |
| Xigduo XR 5 mg-500 mg tablet | Brand | $19.18 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $575.45 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dapagliflozin and metformin been recalled?
The FDA's Enforcement Report lists 2 recalls naming dapagliflozin and metformin since 2021: 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.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dapagliflozin and metformin label say about other medicines?
The dapagliflozin and metformin label names 11 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Acetazolamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with XIGDUO XR may increase the risk for lactic acidosis. |
| Cimetidine | drug interactions | … [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see ]. |
| Dichlorphenamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with XIGDUO XR may increase the risk for lactic acidosis. |
| Dolutegravir | drug interactions | … cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see ]. |
| Isoniazid | drug interactions | … estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| 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 XIGDUO XR initiation and dosage changes. |
| Phenytoin | drug interactions | … thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Ranolazine | drug interactions | Clinical Impact; Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase … |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart … |
| Vandetanib | drug interactions | Clinical Impact; Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase … |
| Zonisamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with XIGDUO XR may increase the risk for lactic acidosis. |
Source: FDA drug label (XIGDUO XR), AstraZeneca Pharmaceuticals LP, effective August 11, 2026 (SPL set ac8a0f7b-9f69-4495-abbc-3a47cd75a859), via openFDA; the full label on DailyMed
What do FAERS reports show for dapagliflozin and metformin?
The FDA Adverse Event Reporting System holds 3,402 reports that list dapagliflozin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 218 are coded as a death and 1,129 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dapagliflozin and metformin?
23 other medicines are given the same way (oral) and in the same FDA class as dapagliflozin and metformin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 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 | none listed | $11.19 per tablet 10 mg tablet | No current entry |
| Canagliflozin | Type 2 diabetes | none listed | $19.13 per tablet 100 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 |
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as dapagliflozin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dapagliflozin and metformin
- 23 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Dapagliflozin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other