FDA-filed SPL labeling · retrieved through openFDA

Ertugliflozin

Ertugliflozin is an SGLT2 inhibitor used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.

Brand name Steglatro
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 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 →

At a glance
Linked label effectiveJun 3, 2026
AvailabilityRx
Earliest approval/marketing year ⓘ2017
FDA-listed product records ⓘ23
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Ertugliflozin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ertugliflozin (Steglatro) helps control blood sugar in adults with type 2 diabetes by causing the kidneys to remove excess glucose through urine, taken as a once-daily oral tablet alongside diet and exercise. It is not for type 1 diabetes. Key risks to stay aware of include diabetic ketoacidosis, genital and urinary tract infections, dehydration, and a higher chance of lower limb amputations — all of which are worth discussing with your care team before starting.

📖 Ertugliflozin: Patient Information Guide

A plain-language walkthrough of Ertugliflozin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Ertugliflozin is used for

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Ertugliflozin is approved for use in adults with type 2 diabetes to help improve blood sugar control alongside diet and exercise.

  • Steglatro (oral tablet) is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes mellitus
  • Steglatro is not recommended for improving blood sugar control in adults with type 1 diabetes mellitus

How Ertugliflozin works

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Ertugliflozin works by blocking a protein in the kidneys called SGLT2 (sodium-glucose co-transporter 2). Normally, SGLT2 reabsorbs most of the glucose filtered by the kidneys back into your bloodstream. By blocking this protein, ertugliflozin prevents that reabsorption — so more glucose is passed out of the body through urine. This lowers blood sugar levels without requiring insulin to do the work. As a bonus, flushing out glucose also pulls more water into the urine, which can mildly lower blood pressure and body weight.

How Ertugliflozin is taken (dosage)

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Steglatro comes as an oral tablet taken once daily in the morning. It can be taken with or without food — eating does not meaningfully affect how much of the drug your body absorbs. If you miss a dose, take it as soon as you remember, but skip it if it's almost time for the next one; never take two doses at once.

  • Your doctor should check your kidney function before you start and periodically after
  • If you're having surgery or a procedure requiring extended fasting, your doctor may ask you to hold Steglatro for at least 4 days beforehand
  • Steglatro is not recommended if your kidney filtration rate (eGFR) is below 45 mL/min/1.73 m²

Ertugliflozin side effects in detail

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The most commonly reported side effects with Steglatro include:

  • Genital yeast infections (in women and men) — the most common side effect
  • Urinary tract infections
  • Increased urination or urgency
  • Headache
  • Vaginal itching
  • Thirst or dry mouth
  • Back pain
  • Mild weight loss

More serious reactions — including diabetic ketoacidosis, severe genital infections (Fournier's gangrene), kidney injury, and problems related to dehydration — require immediate medical attention if they occur. See the warnings section for full details.

Ertugliflozin warnings and precautions

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  • Diabetic ketoacidosis (DKA): Even in type 2 diabetes, Steglatro can trigger dangerous acid build-up in the blood. Blood sugar may not be very high when this happens. Watch for nausea, vomiting, stomach pain, fatigue, or difficulty breathing — stop the medication and seek emergency care right away.
  • Lower limb amputations: Clinical studies showed a higher rate of non-traumatic foot and toe amputations in people using Steglatro, especially those with pre-existing foot problems or poor circulation. Inspect your feet regularly and report any sores or infections promptly.
  • Serious genital infections (Fournier's gangrene): A rare but life-threatening infection in the genital/perineal area has been reported. Seek immediate care if you notice pain, redness, swelling, or fever in that area.
  • Dehydration and kidney injury: Steglatro increases urine output, which can lead to dehydration, low blood pressure, and in some cases acute kidney injury. Older adults and those on diuretics are at higher risk.
  • Low blood sugar (hypoglycemia): Risk increases if you are also taking insulin or a sulfonylurea. Your doctor may lower the dose of those medications when adding Steglatro.
  • Urinary and genital infections: Because more glucose is present in the urine, bacterial and yeast infections are more common. People with a history of these infections are at greater risk.

Ertugliflozin interactions: what it interacts with

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Steglatro can interact with certain medications and affect some lab tests. Key interactions include:

  • Insulin or insulin secretagogues (e.g., sulfonylureas): Combining these with Steglatro increases the risk of low blood sugar — your doctor may reduce the dose of those drugs
  • Lithium: Steglatro may lower lithium levels in the blood; more frequent monitoring of lithium levels is recommended when starting or adjusting Steglatro
  • Urine glucose tests: Steglatro causes glucose to appear in urine, making these tests inaccurate — use blood-based methods to monitor blood sugar instead
  • 1,5-AG blood test: This test for blood sugar control gives unreliable results while you're taking an SGLT2 inhibitor like Steglatro — ask your doctor about alternative monitoring

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Ertugliflozin

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  • Tell your doctor about any allergy to ertugliflozin or the ingredients in Steglatro — serious allergic reactions including severe swelling (angioedema) have been reported
  • Steglatro is not recommended during the second or third trimester of pregnancy due to potential harm to fetal kidney development
  • Steglatro is not recommended while breastfeeding — risk to the infant's developing kidneys cannot be ruled out
  • Safety and effectiveness in children under 18 have not been established
  • Older adults (65 and over) have a higher risk of dehydration and blood pressure drops; kidney function and fluid status should be assessed before starting
  • Steglatro is not recommended if your eGFR (kidney filtration rate) is below 45 mL/min/1.73 m²; kidney function should be checked before and during treatment
  • People with type 1 diabetes should not use Steglatro for blood sugar control — it significantly raises the risk of diabetic ketoacidosis in those patients
  • If you have a history of lower limb problems, poor circulation, foot ulcers, or peripheral artery disease, discuss the amputation risk with your doctor before starting

Ertugliflozin overdose: if you take too much

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If you or someone else takes too much Steglatro, call the Poison Help line at 1-800-222-1222 or seek medical attention. Your care team will manage symptoms based on how you feel. Removing ertugliflozin through dialysis has not been studied.

Pharmacodynamics: what Ertugliflozin does in the body

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Steglatro works by increasing the amount of glucose removed from the body through urine. Higher doses result in near-maximum urinary glucose excretion, and this effect is maintained with continued daily use. Along with glucose, more water is pulled into the urine, so urine volume also increases. Studies have shown that Steglatro does not affect the heart's electrical rhythm (QT interval) at clinically meaningful levels.

Pharmacokinetics: how your body processes Ertugliflozin

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After taking Steglatro by mouth, the drug is absorbed quickly — peak blood levels are reached within about 1 hour on an empty stomach. It can be taken with or without food because food does not meaningfully change how much of the drug your body absorbs overall. The drug reaches stable levels in the blood after about 4 to 6 days of daily dosing. Ertugliflozin is broken down mainly by the liver and cleared through both urine and stool, with an estimated half-life (time for half the drug to leave the body) of about 16.6 hours in people with type 2 diabetes and normal kidney function.

How to store Ertugliflozin

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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’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 →

256

Supplements & herbs that interact with Ertugliflozin

256 supplements and herbal products have documented interactions with Ertugliflozin 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
Every supplement checked against Ertugliflozin — ranked by severity The full interaction hub: 2 major · 215 moderate · 39 minor · every one linked to its full report. Check Ertugliflozin 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

Ertugliflozin 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.

See the full Ertugliflozin 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.

🩺 Ertugliflozin: pharmacist answers to common questions

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

What exactly does Steglatro do for my type 2 diabetes?

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Steglatro helps lower your blood sugar by making your kidneys flush out extra glucose through your urine instead of returning it to your bloodstream. Think of it as giving your kidneys a new job — removing sugar you don't need. It works best when combined with healthy eating and regular physical activity, not as a replacement for those habits.

Can I take Steglatro with my other diabetes medications?

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Yes, Steglatro is often used alongside other diabetes medicines like metformin. However, if you're also taking insulin or a sulfonylurea (like glipizide or glimepiride), there's a higher chance of low blood sugar. Your doctor may lower the dose of those other medicines when you start Steglatro. Always tell your prescriber about everything you take so they can adjust accordingly.

What side effects should I actually expect — and which ones mean I should call someone?

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The most common issue people notice is genital yeast infections, since more sugar in the urine creates a friendlier environment for yeast — this affects both women and men. Urinary tract infections and needing to urinate more often are also fairly common. Those are manageable and worth mentioning to your doctor. On the other hand, if you feel nauseated, start vomiting, have belly pain, or feel unusually tired or short of breath, those could be signs of a serious condition called diabetic ketoacidosis — stop Steglatro and get medical help right away.

I heard something about foot amputations with this type of drug — should I be worried?

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This is a real risk worth taking seriously, though it's more relevant for people who already have foot problems, poor circulation, or a history of foot ulcers. Clinical studies did show a slightly higher rate of amputations — mostly toes and feet — in people taking Steglatro. The best thing you can do is check your feet regularly, keep them clean, wear proper footwear, and report any new sores, cuts, or infections to your doctor promptly. Don't ignore foot pain or changes in skin color.

Is Steglatro safe to take if I'm pregnant or trying to get pregnant?

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Steglatro is not recommended during the second or third trimester of pregnancy because animal studies showed it can affect kidney development in the fetus during that period. If you're planning a pregnancy or find out you're pregnant while taking it, talk to your doctor right away so they can adjust your diabetes treatment. Breastfeeding is also not recommended while on Steglatro, since there may be risk to a nursing infant's developing kidneys.

Do I need to stop Steglatro before having surgery?

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Yes — your doctor will likely ask you to stop Steglatro at least 4 days before any surgery or procedure that requires you to fast for an extended time. This is because fasting combined with this medication can raise the risk of a dangerous acid build-up in the blood called ketoacidosis. Once you're stable after surgery and eating normally again, your doctor will let you know when it's safe to restart.

Is Ertugliflozin available over the counter?

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Ertugliflozin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Ertugliflozin first available?

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Ertugliflozin has been available in the United States since at least 2017, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Ertugliflozin?

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Ertugliflozin is supplied by 10 manufacturers listed in the FDA NDC Directory, including Merck Sharp & Dohme LLC, A-S Medication Solutions, Morepen Laboratories Limtied.

💬 Answers drafted from Ertugliflozin’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 →

🧰 More about Ertugliflozin on HelloPharmacist

💊 Ertugliflozin forms and strengths (how it comes)

Ertugliflozin 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 Steglatro
How this form is used
What it may be used for
  • Steglatro tablets are used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Steglatro tablets are not recommended for improving blood sugar control in adults with type 1 diabetes
Important instructions
  • Steglatro tablets are taken by mouth once daily in the morning, with or without food
  • Steglatro should be withheld for at least 4 days before surgery or procedures that require prolonged fasting, if possible
  • If a Steglatro dose is missed, take it as soon as remembered — do not double the next dose
  • Steglatro is not recommended in patients whose kidney filtration rate (eGFR) is below 45 mL/min/1.73 m²
Available strengths 2 strengths
14 FDA-listed product records ⓘ

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

How Ertugliflozin 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.

1
Dose forms ⓘ
10
Manufacturers
1
Brand names
23
FDA-listed product records ⓘ
2017
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Merck Sharp & Dohme LLC35%
A-S Medication Solutions17%
Morepen Laboratories Limtied9%
MSN Laboratories Private Limited9%
Pfizer Manufacturing Deutschland GmbH9%
Aurobindo Pharma Limited4%
Other makers17%

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

📈 How widely Ertugliflozin is used (Medicaid data)

A general measure of how commonly Ertugliflozin 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 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.

183,513
Medicaid prescriptions filled (Q1–Q4 2025)
$82.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ertugliflozin prescribed? Of the 1,597 medications we measure, Ertugliflozin ranks #405 by Medicaid prescriptions — more than 75% of them.

Where Ertugliflozin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ertugliflozin 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 15 mg oral tablet is the most-dispensed Ertugliflozin product — about 70% of these Medicaid prescriptions.

ertugliflozin 15 MG Oral Tablet Most dispensed

128,306 Medicaid prescriptions (Q1–Q4 2025) 70% of Ertugliflozin prescriptions shown $57.6M gross reimbursement (before rebates) ≈ $449 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992819

ertugliflozin 5 MG Oral Tablet

55,207 Medicaid prescriptions (Q1–Q4 2025) 30% of Ertugliflozin prescriptions shown $24.5M gross reimbursement (before rebates) ≈ $444 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1992810

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, 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 4 of 15 listed Ertugliflozin NDCs with Medicaid activity.

🔍 Compare Ertugliflozin products

A representative set of FDA-listed product records for Ertugliflozin — 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 23 of 23 products — FDA National Drug Code Directory. See every product, package size and price: browse all 23 Ertugliflozin NDCs →

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) Ertugliflozin RxCUI 1992672 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1992809 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1992810 15 MG RxCUI 1992819

Look up RxCUI 1992672 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.

🏷️ Ertugliflozin brand names

Steglatro

🏭 Who makes Ertugliflozin: manufacturers and labelers

Merck Sharp & Dohme LLC 8 A-S Medication Solutions 4 Morepen Laboratories Limtied 2 MSN Laboratories Private Limited 2 Pfizer Manufacturing Deutschland GmbH 2 Aurobindo Pharma Limited 1 Azico Biophore India Private Limited 1 Hikal Limited 1 Honour Lab Limited 1 Upjohn Manufacturing Ireland Unlimited Company 1

Ertugliflozin drug class (RxNorm)

Ertugliflozin belongs to the Sodium-glucose co-transporter 2 (SGLT2) inhibitors class.

Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) 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 Ertugliflozin 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 Ertugliflozin.
📈
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 Ertugliflozin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
23
Distinct labelers/manufacturers represented
10
Linked representative label ⓘ
Merck Sharp & Dohme LLC
Linked label effective
Jun 3, 2026
Composite sections available
23
Linked SPL Set ID
e6f3e718-bb99-48f1-ab94-b9f0af05fed6
Linked SPL Document ID
17e6fd06-3cc6-4bad-8809-76e38dbc4471
Open the linked representative label on DailyMed ↗

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.