Quick answers
- What is Ertugliflozin and sitagliptin used for?
- The FDA-approved label (Steglujan, Merck Sharp & Dohme LLC, June 3, 2026) says: “STEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus […]. Has not been studied in patients with a history of pancreatitis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Ertugliflozin and sitagliptin?
- The “Adverse Reactions” section of the FDA label (Steglujan, Merck Sharp & Dohme LLC, June 3, 2026) begins: “The following important adverse reactions are described 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)] Lower Limb Amputation [see Warnings and Precautions (5.3)] Acute Renal Failure [see Warnings and Precautions (5.4)] Volume Depletion [see Warnings and Precautions (5.5)] Genitourinary Infections, including Urosepsis …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Ertugliflozin and sitagliptin?
- The “Drug Interactions” section of the FDA label (Steglujan, Merck Sharp & Dohme LLC, June 3, 2026) begins: “Table 3: Clinically Significant Drug Interactions with STEGLUJAN Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when STEGLUJAN is used in combination with insulin or an insulin secretagogue. Intervention: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLUJAN.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ertugliflozin and sitagliptin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ertugliflozin and sitagliptin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ertugliflozin and sitagliptin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ertugliflozin and sitagliptin?
- 1 company lists prescription products of Ertugliflozin and sitagliptin in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Ertugliflozin and sitagliptin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
STEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus […]. Has not been studied in patients with a history of pancreatitis. …
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Steglujan, Merck Sharp & Dohme LLC; it covers 2 products 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.
Ertugliflozin and sitagliptin 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 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)] Lower Limb Amputation [see Warnings and Precautions (5.3)] Acute Renal Failure [see Warnings and Precautions (5.4)] Volume Depletion [see Warnings and Precautions (5.5)] Genitourinary Infections, including Urosepsis …
Table from the label
| Number (%) of Patients | |||
|---|---|---|---|
| Placebo N = 515 | Ertugliflozin 5 mg N = 519 | Ertugliflozin 15 mg N = 510 | |
| Female genital mycotic infectionsIncludes: genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, and vulvovaginitis. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245). | 3.0% | 9.1% | 12.2% |
| Male genital mycotic infectionsIncludes: balanitis candida, balanoposthitis, genital infection, and genital infection fungal. Percentages calculated with the number of male patients in each group as denominator: placebo (N=280), ertugliflozin 5 mg (N=267), ertugliflozin 15 mg (N=265). | 0.4% | 3.7% | 4.2% |
| Urinary tract infectionsIncludes: cystitis, dysuria, streptococcal urinary tract infection, urethritis, urinary tract infection. | 3.9% | 4.0% | 4.1% |
| Headache | 2.3% | 3.5% | 2.9% |
| Vaginal pruritusIncludes: vulvovaginal pruritus and pruritus genital. Percentages calculated with the number of female patients in each group as denominator: placebo (N=235), ertugliflozin 5 mg (N=252), ertugliflozin 15 mg (N=245). | 0.4% | 2.8% | 2.4% |
| Increased urinationIncludes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia. | 1.0% | 2.7% | 2.4% |
| Nasopharyngitis | 2.3% | 2.5% | 2.0% |
| Back pain | 2.3% | 1.7% | 2.5% |
| Weight decreased | 1.0% | 1.2% | 2.4% |
| ThirstIncludes: thirst, dry mouth, polydipsia, and dry throat. | 0.6% | 2.7% | 1.4% |
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. This is part of the section. Read the full label on DailyMed →
Ertugliflozin and sitagliptin 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 Significant Drug Interactions with STEGLUJAN Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when STEGLUJAN is used in combination with insulin or an insulin secretagogue. Intervention: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLUJAN.
Read more of this section
Lithium Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during STEGLUJAN 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 STEGLUJAN with laboratory tests. (7)
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. This is part of the section. Read the full label on DailyMed →
Ertugliflozin and sitagliptin 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 initiating and as clinically indicated. (2.1) Correct volume depletion before initiating. (2.1) Recommended starting dosage is 5 mg ertugliflozin/100 mg sitagliptin orally once daily, taken in the morning, with or without food. (2.2) Increase dosage to 15 mg ertugliflozin/100 mg sitagliptin orally once daily in those tolerating STEGLUJAN and needing additional glycemic control.
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(2.2) Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2. (2.2) Withhold STEGLUJAN for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. (2.3) 2.1 Prior to Initiation of STEGLUJAN Assess renal function before initiating STEGLUJAN and as clinically indicated [see Warnings and Precautions (5.4)]. Assess volume status. In patients with volume depletion, correct this condition before initiating STEGLUJAN [see Warnings and Precautions (5.5) and Use in Specific Populations (8.5, 8.6)]. 2.2 Recommended Dosage The recommended starting dosage of STEGLUJAN is 5 mg ertugliflozin/100 mg sitagliptin orally once daily, taken in the morning, with or without food. For patients treated with ertugliflozin who are being switched to STEGLUJAN, the dosage of ertugliflozin can be maintained. For additional glycemic control, the dosage may be increased to 15 mg ertugliflozin/100 mg sitagliptin orally once daily in patients tolerating STEGLUJAN. Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2. Use of STEGLUJAN is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2), end-stage renal disease (ESRD) or on dialysis [see Contraindications (4)]. 2.3 Temporary Interruption for Surgery Withhold STEGLUJAN for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume STEGLUJAN when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2)]. 2.4 Recommendations Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Advise patients not to double up the next dose.
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. Read the full label on DailyMed →
Ertugliflozin and sitagliptin 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 ertugliflozin, STEGLUJAN is not recommended during the second and third trimesters of pregnancy. The limited available data with ertugliflozin and sitagliptin use during pregnancy are not sufficient to determine a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).
Read more of this section
In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible. There was no evidence of fetal harm in rats or rabbits at exposures of ertugliflozin approximately 300 times higher than the maximal clinical dose of 15 mg/day when administered during organogenesis (see Data). In rats and rabbits, sitagliptin doses of 250 and 125 mg/kg, respectively (approximately 30 and 20 times the human exposure at the maximum recommended human dose) did not adversely affect development outcomes of either species. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with HbA1c >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 2-4% and 15-20%, respectively.
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. Read the full label on DailyMed →
When Ertugliflozin and sitagliptin should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
STEGLUJAN is contraindicated in patients with: Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2), end-stage renal disease (ESRD), or on dialysis [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)]. Hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in STEGLUJAN. Reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precautions (5.9) and Adverse Reactions (6.2)].
Read more of this section
Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2), end-stage renal disease, or dialysis. (4) Hypersensitivity to sitagliptin, ertugliflozin, or any excipient in STEGLUJAN. (4, 5.9, 6.2)
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. Read the full label on DailyMed →
Ertugliflozin and sitagliptin 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).
STEGLUJAN In the event of an overdose with STEGLUJAN, contact the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures as dictated by the patient's clinical status. Ertugliflozin Removal of ertugliflozin by hemodialysis has not been studied.
Read more of this section
Sitagliptin In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
— FDA label: Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Steglujan |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ertugliflozin pidolate 15 mg · sitagliptin phosphate 100 mg tablet, film coated | Brand: Steglujan | $17.59 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Merck Sharp & Dohme LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209805 STEGLUJAN | Msd Sub Merck | December 19, 2017 | 11, latest June 3, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1992826, 1992832, 1992835, 1992837 |
|---|---|
| SPL set ID of the quoted label | c2c553d8-5a9d-4366-bf53-8bdb5a876d19 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA209805 |
| Active ingredients (FDA) | ERTUGLIFLOZIN PIDOLATE / SITAGLIPTIN PHOSPHATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- DiabetesCondition named on the label: hospitals that treat it
- Merck Sharp & Dohme LLCMaker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Steglujan, Merck Sharp & Dohme LLC, effective June 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →