Dapagliflozin and saxagliptin

What Dapagliflozin and saxagliptin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus […]. …

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Dapagliflozin and saxagliptin side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following important adverse reactions are described below or elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see WARNINGS AND PRECAUTIONS (5.1)] Pancreatitis [see WARNINGS AND PRECAUTIONS (5.2)] Heart Failure [see WARNINGS AND PRECAUTIONS (5.3)] Volume Depletion [see WARNINGS AND PRECAUTIONS (5.4)] Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS (5.5)] Hypoglycemia with Concomitant Use of …

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. This is part of the section. Read the full label on DailyMed →

Dapagliflozin and saxagliptin drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Table 3: Clinically Relevant Interactions with Dapagliflozin and Saxagliptin Strong Inhibitors of CYP3A4/5 Enzymes Clinical Impact Ketoconazole significantly increased saxagliptin exposure. Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).

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Intervention Do not coadminister dapagliflozin and saxagliptin with strong cytochrome P450 3A4/5 inhibitors [see DOSAGE AND ADMINISTRATION (2.4) and CLINICAL PHARMACOLOGY (12.3)]. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when dapagliflozin and saxagliptin is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see WARNINGS AND PRECUATIONS (5.6)]. 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 and saxagliptin 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. Strong CYP3A4/5 Inhibitors (e.g., Ketoconazole): Do not coadminister dapagliflozin and saxagliptin with strong cytochrome P450 3A4/5 inhibitors. (7) See full prescribing information for additional drug interactions and information on interference of dapagliflozin and saxagliptin with laboratory tests. (7)

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. This is part of the section. Read the full label on DailyMed →

Dapagliflozin and saxagliptin dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Assess renal function before initiation of therapy and periodically thereafter. (2.1) Take orally, once daily in the morning with or without food. (2.2) For patients not already taking dapagliflozin, the recommended starting dose of dapagliflozin and saxagliptin tablets is a 5 mg dapagliflozin/5 mg saxagliptin tablet once daily.

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(2.2) In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require additional glycemic control, the dapagliflozin and saxagliptin tablets dose can be increased to 10 mg dapagliflozin/5 mg saxagliptin tablet once daily. (2.2) Swallow tablet whole. Do not crush, cut or chew. (2.2) Withhold dapagliflozin and saxagliptin for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. (2.5) 2.1 Prior to Initiation of Dapagliflozin and Saxagliptin Tablets Assess renal function prior to initiation of dapagliflozin and saxagliptin tablets therapy and periodically thereafter [see WARNINGS AND PRECAUTIONS (5.4)]. Assess volume status. In patients with volume depletion, correct this condition before initiating of dapagliflozin and saxagliptin tablets [see WARNINGS AND PRECAUTIONS (5.4) and USE IN SPECIFIC POPULATIONS (8.5, 8.6)]. 2.2 Dosage For patients not already taking dapagliflozin, the recommended starting dose of dapagliflozin and saxagliptin tablets is a 5 mg dapagliflozin/5 mg saxagliptin tablet taken orally once daily in the morning with or without food. In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require additional glycemic control, the dapagliflozin and saxagliptin tablets dose can be increased to 10 mg dapagliflozin/5 mg saxagliptin tablet once daily in the morning with or without food. Swallow whole. Do not crush, cut or chew dapagliflozin and saxagliptin tablets. 2.3 Patients with Renal Impairment No dose adjustment is needed in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2. Dapagliflozin and saxagliptin tablets are contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see CONTRAINDICATIONS (4) and USE IN SPECIFIC POPULATIONS (8.6)]. 2.4 Use with Strong CYP3A4/5 Inhibitors Do not coadminister dapagliflozin and saxagliptin tablets with strong cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) [see DRUG INTERACTIONS (7)]. 2.5 Temporary Interruption for Surgery Withhold dapagliflozin and saxagliptin tablets for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume dapagliflozin and saxagliptin tablets when the patient is clinically stable and has resumed oral intake [see WARNINGS AND PRECAUTIONS (5.1) and CLINICAL PHARMACOLOGY (12.2)].

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. Read the full label on DailyMed →

Dapagliflozin and saxagliptin in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Based on animal data showing adverse renal effects from dapagliflozin, dapagliflozin and saxagliptin is not recommended during the second and third trimesters of pregnancy. The limited available data with dapagliflozin and saxagliptin or its components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.

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There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). In animal studies, adverse renal pelvic and tubular dilatations, that were not fully reversible, were observed in rats when dapagliflozin (a component of dapagliflozin and saxagliptin) was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see Data). No adverse developmental effects were observed when saxagliptin was administered to pregnant rats and rabbits (see Data). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with an HbA1c greater than 10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo-fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data Dapagliflozin Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose was 15-times the 10 mg clinical dose, (based on AUC). The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation Day 6 through lactation Day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21 day-old pup offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC). Dose-related reductions in pup body weights were observed at greater than or equal to 29-times the 10 mg clinical dose (based on AUC). No adverse effects on developmental endpoints were noted at 1 mg/kg/day, (19-times the 10 mg clinical dose, based on AUC).

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. This is part of the section. Read the full label on DailyMed →

When Dapagliflozin and saxagliptin should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Dapagliflozin and saxagliptin is contraindicated in patients with: History of a serious hypersensitivity reactions to dapagliflozin or to saxagliptin, including anaphylactic reaction, angioedema or exfoliative skin conditions [see WARNINGS AND PRECAUTIONS (5.8) and ADVERSE REACTIONS (6.2)]. Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m 2), end-stage renal disease (ESRD), or patients on dialysis [see USE IN SPECIFIC POPULATIONS (8.6)].

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History of a serious hypersensitivity reaction to dapagliflozin or to saxagliptin. (4) Moderate to severe renal impairment (eGFR <45 mL/min/1.73 m 2), end-stage renal disease, or patients on dialysis. (4)

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. Read the full label on DailyMed →

Dapagliflozin and saxagliptin overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

In the event of an overdose, contact the Poison Control Center. Appropriate supportive treatment should be initiated as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied. Saxagliptin and its major metabolite can be removed by hemodialysis (23% of dose over 4 hours).

— FDA label: Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• DapagliflozinFarxiga · 50 products
• Dapagliflozin and metformin hydrochlorideXigduo XR · 37 products
• Saxagliptin6 products
• Saxagliptin and metformin hydrochloride6 products

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Novadoz Pharmaceuticals LLC1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (1)

• ANDA211533Msn · April 6, 2026

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Dapagliflozin and Saxagliptin, Novadoz Pharmaceuticals LLC, effective April 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

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