Ertugliflozin / Sitagliptin
Ertugliflozin and sitagliptin is a two-medicine combination used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
🧬 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 1 clinical label set 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 →
📖 Ertugliflozin / Sitagliptin: Patient Information Guide
A plain-language walkthrough of Ertugliflozin / Sitagliptin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ertugliflozin/sitagliptin is a combination medicine used to help control blood sugar in adults with type 2 diabetes, always alongside diet and exercise.
- Steglujan (ertugliflozin/sitagliptin tablet, taken by mouth) is approved to improve blood sugar control in adults with type 2 diabetes mellitus as an add-on to diet and exercise
- Steglujan is not recommended for people with type 1 diabetes
- Steglujan has not been studied in people with a history of pancreatitis — it is unknown whether this group faces additional risk
⚙️How it works▾
Steglujan brings together two medicines that lower blood sugar in completely different ways. Ertugliflozin blocks a transporter in the kidneys called SGLT2, which normally recycles glucose back into the blood — blocking it lets the body excrete excess glucose through the urine. Sitagliptin blocks an enzyme called DPP-4 that normally breaks down incretin hormones (natural signals that tell the pancreas to make more insulin and the liver to make less glucose after a meal) — by slowing that breakdown, sitagliptin keeps those helpful hormones active longer, especially in response to food.
💊How it's taken▾
Steglujan comes as an oral tablet and is taken once daily in the morning, with or without food. Your doctor will start you on the lower strength and may increase it if your blood sugar needs more control. If you miss a dose, take it as soon as you remember — but skip it if it is almost time for the next one, and never take two doses at once.
- Take Steglujan in the morning, with or without food
- Stop Steglujan at least 4 days before planned surgery or a procedure that requires fasting — restart only when you are stable and eating again
- Your kidney function will be checked before you start and periodically during treatment
🤒Side effects — in detail▾
The most commonly reported side effects include:
- Genital yeast infections (more common in women, but can occur in men too)
- Urinary tract infections
- Increased urination
- Headache
- Nasopharyngitis (runny nose, congestion) and upper respiratory infections
- Vaginal itching
- Back pain
- Weight loss
- Increased thirst
Some reactions are serious enough to require urgent care — including ketoacidosis (dangerous acid buildup in the blood), severe genital or perineal infections (Fournier's gangrene), kidney injury, acute pancreatitis, and severe allergic reactions. Contact your doctor or go to the ER immediately if you experience any of these.
⚠️Warnings & precautions▾
- Ketoacidosis: A life-threatening acid buildup in the blood can occur even when blood sugar is not very high. Symptoms include nausea, vomiting, stomach pain, fatigue, and shortness of breath. Stop Steglujan and seek emergency care right away if these occur.
- Lower limb amputation: In a cardiovascular outcomes study, ertugliflozin was associated with a higher rate of non-traumatic lower limb amputations — most often involving the toe or foot. Check your feet regularly and report any sores, infections, or pain.
- Serious genital and urinary infections: Including rare, life-threatening Fournier's gangrene (necrotizing fasciitis of the perineum). Seek immediate care for pain, redness, swelling, or a foul odor in the genital area plus fever.
- Pancreatitis: Post-marketing reports link sitagliptin to acute pancreatitis, including severe cases. Stop Steglujan and contact your doctor if you have sudden, severe stomach pain.
- Kidney injury and volume depletion: Steglujan can cause dehydration and reduced blood flow to the kidneys. Older adults and those on diuretics are at higher risk.
- Hypersensitivity reactions: Sitagliptin has been associated with serious allergic reactions including anaphylaxis and Stevens-Johnson syndrome (a severe skin reaction), usually within the first 3 months of use.
- Heart failure: An association between DPP-4 inhibitors and heart failure has been observed with other medicines in this class. Report shortness of breath, leg swelling, or sudden weight gain.
- Severe joint pain and bullous pemphigoid (blistering skin): Reported with DPP-4 inhibitors; discontinue and consult your doctor if these occur.
🔀What it interacts with▾
Steglujan can interact with several medicines and tests — here are the most important ones:
- Insulin or sulfonylureas (e.g., glimepiride, glipizide): Combining these with Steglujan raises your risk of low blood sugar (hypoglycemia). Your doctor may reduce the dose of insulin or the sulfonylurea.
- Lithium (used for bipolar disorder): Steglujan may lower lithium levels in the blood, requiring more frequent monitoring.
- Urine glucose tests: Steglujan causes glucose to spill into the urine on purpose — so urine glucose test strips will falsely read high and cannot be used to monitor your diabetes control.
- 1,5-AG blood test: This blood test for short-term glucose monitoring is also unreliable while you are on Steglujan. Ask your doctor about alternative monitoring methods.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Severe kidney disease or dialysis: Steglujan is contraindicated — it must not be used if your eGFR is below 30 mL/min/1.73 m², if you have end-stage kidney disease, or if you are on dialysis
- Moderate kidney impairment: Steglujan is not recommended if your eGFR is below 45 mL/min/1.73 m²
- Allergy to ertugliflozin or sitagliptin: Steglujan is contraindicated if you have had a serious allergic reaction (such as anaphylaxis or angioedema) to either ingredient
- Pregnancy: Not recommended in the second or third trimester due to potential harm to the baby's developing kidneys; discuss risks with your doctor if you are pregnant or planning to become pregnant
- Breastfeeding: Not recommended — both medicines are present in animal milk, and there is a potential risk to the infant's developing kidneys
- Children under 18: Safety and effectiveness have not been established
- Older adults (65+): At higher risk for dehydration-related side effects and kidney changes; closer monitoring is warranted
- History of pancreatitis: It is unknown whether this increases the risk of developing pancreatitis while on Steglujan
- Risk factors for heart failure: Tell your doctor if you have a history of heart failure or kidney impairment before starting
- Prior angioedema with a DPP-4 inhibitor: Use with caution; your doctor should weigh the risks carefully
🚑If you take too much▾
If you or someone else takes too much Steglujan, call the Poison Help line at 1-800-222-1222 or seek emergency care right away. Standard supportive treatment is recommended. Sitagliptin can be partially removed by hemodialysis (dialysis), while ertugliflozin has not been studied in that context.
📡Pharmacodynamics — effects in the body▾
Ertugliflozin causes the kidneys to excrete more glucose in the urine, and this effect increases urinary volume as well. Sitagliptin inhibits DPP-4 activity for a full 24-hour period after a dose; in response to a meal or oral glucose, this leads to a 2- to 3-fold increase in active incretin hormone levels, more insulin release from the pancreas, and lower glucagon levels — all resulting in better blood sugar control throughout the day. Neither component causes meaningful changes in the heart's electrical rhythm (QTc interval) at therapeutic doses.
🔬Pharmacokinetics — how your body processes it▾
Both ertugliflozin and sitagliptin are absorbed by mouth and can be taken with or without food — a high-fat meal lowers the peak blood level of ertugliflozin slightly but does not meaningfully change overall exposure. Ertugliflozin reaches peak levels in about 1 hour and reaches steady state in 4 to 6 days; it is primarily broken down by the liver and excreted in urine and feces. Sitagliptin is rapidly absorbed, peaks within 1 to 4 hours, and has a half-life (the time for blood levels to fall by half) of about 12 hours; roughly 79% of sitagliptin is cleared by the kidneys unchanged, which is why kidney function matters for dosing.
📦How to store it▾
Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (between 59°F-86°F) . Protect from moisture. Store in a dry place.
📄 Written from Ertugliflozin / Sitagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ertugliflozin / Sitagliptin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Steglujan do for my type 2 diabetes? ▾
Can I take Steglujan with my other diabetes medicines like insulin or metformin? ▾
What side effects should I actually watch out for? ▾
Do I need to stop Steglujan before surgery? ▾
Is it safe to take Steglujan if I'm pregnant or breastfeeding? ▾
I heard this medicine can cause problems with kidney or heart health — should I be worried? ▾
Is Ertugliflozin / Sitagliptin available over the counter? ▾
When was Ertugliflozin / Sitagliptin first available? ▾
Who makes Ertugliflozin / Sitagliptin? ▾
💬 Answers drafted from Ertugliflozin / Sitagliptin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ertugliflozin / Sitagliptin comes
Ertugliflozin / Sitagliptin 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
How this form is used
- Steglujan is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus
- Steglujan is not recommended for type 1 diabetes or for patients on dialysis
- Steglujan tablets are taken by mouth once daily in the morning, with or without food
- Steglujan should be stopped at least 4 days before surgery or procedures that require prolonged fasting, and restarted only when you are eating normally and your doctor says it is safe
- If you miss a dose of Steglujan, take it as soon as you remember — do not double up on your next dose
- Steglujan is not recommended if your kidney filtration rate (eGFR) is below 45 mL/min/1.73 m²
📊 Ertugliflozin / Sitagliptin across the U.S. market
How Ertugliflozin / Sitagliptin 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ertugliflozin / Sitagliptin is used
A general measure of how commonly Ertugliflozin / Sitagliptin 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 Ertugliflozin / Sitagliptin 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.
How commonly is Ertugliflozin / Sitagliptin prescribed? Of the 1,596 medications we measure, Ertugliflozin / Sitagliptin ranks #1,340 by Medicaid prescriptions — more than 16% of them.
Utilization by Ertugliflozin / Sitagliptin 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.
ertugliflozin 15 MG / sitagliptin 100 MG Oral Tablet Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992826
ertugliflozin 5 MG / sitagliptin 100 MG Oral Tablet
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992835
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 Ertugliflozin / Sitagliptin, 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 2 of 12 listed Ertugliflozin / Sitagliptin NDCs with Medicaid activity.
🔍 Compare Ertugliflozin / Sitagliptin products
A representative set of FDA-listed product records for Ertugliflozin / Sitagliptin — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| ERTUGLIFLOZIN PIDOLATE 5 mg/1; SITAGLIPTIN PHOSPHATE 100 mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| ERTUGLIFLOZIN PIDOLATE 15 mg/1; SITAGLIPTIN PHOSPHATE 100 mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| 5; 100 mg/1; mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| 15; 100 mg/1; mg | Oral | Merck Sharp & Dohme LLC × 2 listings | NDA | View NDC → |
| ERTUGLIFLOZIN PIDOLATE 5 mg/1; SITAGLIPTIN PHOSPHATE 100 mg | — | Organon Heist | DRUG FOR FURTHER PROCESSING | View NDC → |
| ERTUGLIFLOZIN PIDOLATE 15 mg/1; SITAGLIPTIN PHOSPHATE 100 mg | — | Organon Heist | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Ertugliflozin / Sitagliptin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ertugliflozin / Sitagliptin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ertugliflozin / Sitagliptin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ertugliflozin / Sitagliptin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1992825 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1992824In current FDA listingsClinical drug / strength (SCD) ertugliflozin 15 MG / sitagliptin 100 MGRxCUI 1992826ertugliflozin 5 MG / sitagliptin 100 MGRxCUI 1992835
Look up RxCUI 1992825 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.
📦 Supply & shortage status
Whether Ertugliflozin / Sitagliptin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ertugliflozin / Sitagliptin belongs to the Sodium-glucose co-transporter 2 (SGLT2) inhibitors class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Merck Sharp & Dohme LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.