Empagliflozin / Linagliptin
Empagliflozin/linagliptin is a combination medicine used to improve blood sugar control in adults with type 2 diabetes, and the empagliflozin component also reduces the risk of death from cardiovascular disease in adults who have both type 2 diabetes and established heart disease.
🧬 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 →
📖 Empagliflozin / Linagliptin: Patient Information Guide
A plain-language walkthrough of Empagliflozin / Linagliptin — 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▾
Empagliflozin/linagliptin is a combination ingredient used in type 2 diabetes management; below are all supported uses based on the available product evidence.
- Glyxambi (oral tablet) is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus
- The empagliflozin component in Glyxambi is specifically indicated to reduce the risk of death from cardiovascular disease in adults with type 2 diabetes who already have established cardiovascular disease
- Glyxambi is not recommended for improving blood sugar control in people with type 1 diabetes — it significantly increases the risk of diabetic ketoacidosis in that population
- Glyxambi is not recommended for blood sugar control in adults with type 2 diabetes whose kidney function is severely reduced (eGFR below 30 mL/min/1.73 m²), as it is unlikely to be effective
- Glyxambi has not been studied in people with a history of pancreatitis
⚙️How it works▾
Glyxambi combines two medicines with different but complementary mechanisms. Empagliflozin blocks a kidney transporter called SGLT2 — the protein responsible for pulling glucose (sugar) from filtered urine back into the blood. By blocking it, empagliflozin causes the kidneys to excrete excess glucose in the urine, directly lowering blood sugar levels. Linagliptin inhibits an enzyme called DPP-4, which normally breaks down incretin hormones (GLP-1 and GIP). With more active incretins circulating, the pancreas releases more insulin after meals, and the liver releases less glucose — both effects help keep blood sugar in a healthier range.
💊How it's taken▾
Glyxambi is taken as one tablet by mouth once a day, in the morning, with or without food. Your prescriber may start you on a lower-strength tablet and increase it if additional blood sugar control is needed. If you miss a dose, take it as soon as you remember — but skip it if it is almost time for your next dose, and never take two doses at once.
- Take in the morning, with or without food
- Hold Glyxambi for at least 3 days before scheduled surgery or any procedure requiring extended fasting, if possible; restart only when you are stable and eating again
- Your doctor will check your kidney function before you start and periodically during treatment
🤒Side effects — in detail▾
The most common side effects with Glyxambi include:
- Urinary tract infections
- Nasopharyngitis (cold-like symptoms)
- Upper respiratory tract infections
- Genital yeast infections (more common in women, but can affect men too)
- Increased urination
- Nausea
- Diarrhea
- Increased thirst
More serious reactions — including diabetic ketoacidosis, acute pancreatitis, severe allergic reactions, a dangerous genital/perineal infection called Fournier's gangrene, severe joint pain, and a skin blistering condition called bullous pemphigoid — have been reported and require prompt medical attention if they occur.
⚠️Warnings & precautions▾
- Diabetic ketoacidosis (DKA): A dangerous build-up of acids in the blood can occur even when blood sugar is not dramatically high. Risk factors include skipped insulin doses, illness, reduced food intake, surgery, or alcohol. Symptoms include nausea, vomiting, belly pain, and shortness of breath. Stop Glyxambi and get emergency care if these appear.
- Pancreatitis: Acute, sometimes fatal, inflammation of the pancreas has been reported with linagliptin. Seek care immediately for severe, persistent abdominal pain.
- Volume depletion (dehydration): Empagliflozin's diuretic-like effect can lower blood pressure and impair kidney function, especially in older adults, people with kidney impairment, or those taking water pills.
- Serious genitourinary infections: These range from yeast infections to life-threatening Fournier's gangrene (a severe infection of the genital/perineal area). Seek immediate care for pain, swelling, redness, or fever in that area.
- Low blood sugar (hypoglycemia): Risk increases if Glyxambi is combined with insulin or sulfonylureas. Dose adjustments of those medicines may be needed.
- Lower limb amputations: A signal of increased amputation risk has been seen in some empagliflozin trials, particularly in those with peripheral artery disease or diabetic foot problems. Routine foot care and reporting sores or new pain is important.
- Heart failure: DPP-4 inhibitors as a class have been associated with heart failure in some trials. Monitor for shortness of breath, leg swelling, or rapid weight gain.
- Bullous pemphigoid: A serious blistering skin condition has been reported. Report any new blisters or skin erosions to your doctor.
- Severe joint pain: Disabling arthralgia has been reported with linagliptin. Tell your doctor if you develop sudden, severe joint pain.
🔀What it interacts with▾
Several medicines and lab tests can interact meaningfully with Glyxambi:
- Diuretics (water pills): Taken together, dehydration and low blood pressure risk increases — volume status should be assessed before starting Glyxambi
- Insulin or sulfonylureas (e.g., glipizide, glimepiride): Raise the risk of hypoglycemia (low blood sugar); dose reductions of those medicines may be needed
- Lithium: Glyxambi can reduce lithium levels in the blood; more frequent monitoring is recommended when starting or adjusting Glyxambi
- Strong P-gp or CYP3A4 inducers (e.g., rifampin): Can significantly reduce linagliptin's effectiveness; alternative diabetes treatments are strongly recommended if this combination is unavoidable
- Urine glucose tests: Glyxambi causes glucose to spill into urine intentionally — this makes urine glucose testing unreliable for monitoring blood sugar control; use blood-based tests instead
- 1,5-AG blood test: This glycemic monitoring test is also unreliable in people taking SGLT2 inhibitors like empagliflozin; use alternative 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▾
- Do not take Glyxambi if you have had a serious allergic reaction — such as anaphylaxis, angioedema (swelling of the face or throat), or severe skin reactions — to empagliflozin, linagliptin, or any inactive ingredient in the tablet
- Glyxambi is not for people with type 1 diabetes — it greatly increases the risk of a dangerous complication called diabetic ketoacidosis in that group
- Not recommended if your kidney function is severely reduced (eGFR below 30) — it is unlikely to work well and may worsen kidney health
- Glyxambi has not been studied in people with a history of pancreatitis; the risk in that group is unknown
- Pregnancy: Not recommended during the second or third trimester due to potential risk of harm to the baby's developing kidneys based on animal studies. Poorly controlled diabetes in pregnancy also carries its own risks — discuss your options with your doctor
- Breastfeeding: Not recommended — the medicine may pass into breast milk and could affect the developing kidneys of a nursing infant
- Children: Safety and effectiveness have not been established in pediatric patients
- Older adults (especially 75 and over): Higher risk of dehydration, low blood pressure, and urinary tract infections; extra monitoring is warranted
- If you have a history of heart failure or kidney impairment, discuss the risks and benefits carefully with your prescriber before starting
- Liver disease: Glyxambi may be used in patients with hepatic (liver) impairment, per the label
🚑If you take too much▾
If you think you or someone else has taken too much Glyxambi, call the Poison Help line at 1-800-222-1222 or contact a medical toxicologist right away. Removing empagliflozin by hemodialysis has not been studied, and removing linagliptin by dialysis is unlikely to be effective.
📡Pharmacodynamics — effects in the body▾
Empagliflozin causes the kidneys to excrete more glucose in the urine — beginning almost immediately after the first dose and remaining consistent throughout treatment. It also modestly increases urine volume, particularly in the first day of use. Linagliptin works in a glucose-dependent way: it boosts insulin release and reduces glucagon (a hormone that raises blood sugar) mainly when blood sugar is elevated, which helps explain its lower risk of causing hypoglycemia on its own. Neither component has been shown to cause abnormal heart rhythm changes, even at doses far above the recommended amounts.
🔬Pharmacokinetics — how your body processes it▾
Glyxambi can be taken with or without food — while food slightly reduces the peak concentration of both ingredients, the overall exposure is not meaningfully changed, so it is not clinically significant. Empagliflozin reaches peak blood levels about 1.5 hours after a dose and has an elimination half-life of roughly 12 hours, with most of the drug cleared through both urine and stool. Linagliptin has a much longer terminal half-life (around 200 hours at steady state), though it accumulates to a stable level in about 11 hours of effective half-life; roughly 90% of it leaves the body unchanged, mostly through the digestive system. Because empagliflozin continues to cause glucose to spill into the urine for about 3 days after the last dose, monitoring and ketoacidosis precautions remain relevant even after stopping the medicine.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
📄 Written from Empagliflozin / Linagliptin’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 Empagliflozin / Linagliptin — the kind of thing our pharmacy team would talk through with you at the counter.
What is Glyxambi actually doing to help my diabetes? ▾
I keep hearing about a dangerous condition called ketoacidosis. Should I be worried? ▾
Are yeast infections and urinary tract infections really that common with this medicine? ▾
Is it safe to take Glyxambi if I'm also on insulin? ▾
Can I take Glyxambi if I'm pregnant or thinking about getting pregnant? ▾
Do I need to stop Glyxambi before having surgery? ▾
Is Empagliflozin / Linagliptin available over the counter? ▾
When was Empagliflozin / Linagliptin first available? ▾
💬 Answers drafted from Empagliflozin / Linagliptin’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 Empagliflozin / Linagliptin comes
Empagliflozin / Linagliptin 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
- Glyxambi is used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus
- The empagliflozin component in Glyxambi is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
- Glyxambi is taken once daily in the morning, with or without food
- Glyxambi should be withheld for at least 3 days, if possible, before surgery or procedures that require prolonged fasting
- If a Glyxambi dose is missed, take it as soon as possible — do not double up the next dose
- Before starting Glyxambi, your doctor will check your kidney function and assess for dehydration
📊 Empagliflozin / Linagliptin across the U.S. market
How Empagliflozin / Linagliptin 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.
📈 How widely Empagliflozin / Linagliptin is used
A general measure of how commonly Empagliflozin / Linagliptin 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 Empagliflozin / Linagliptin 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 Empagliflozin / Linagliptin prescribed? Of the 1,597 medications we measure, Empagliflozin / Linagliptin ranks #983 by Medicaid prescriptions — more than 38% of them.
Utilization by Empagliflozin / Linagliptin 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.
empagliflozin 25 MG / linagliptin 5 MG Oral Tablet Most dispensed
Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1602118
empagliflozin 10 MG / linagliptin 5 MG Oral Tablet
Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1602109
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 Empagliflozin / Linagliptin, 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 6 of 8 listed Empagliflozin / Linagliptin NDCs with Medicaid activity.
🔍 Compare Empagliflozin / Linagliptin products
A representative set of FDA-listed product records for Empagliflozin / Linagliptin — 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 | ||||
| EMPAGLIFLOZIN 10 mg/1; LINAGLIPTIN 5 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| EMPAGLIFLOZIN 25 mg/1; LINAGLIPTIN 5 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| 10; 5 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 25; 5 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Empagliflozin / Linagliptin 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 Empagliflozin / Linagliptin — 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 Empagliflozin / Linagliptin 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 Empagliflozin / Linagliptin 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 1598392 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1602108In current FDA listingsClinical drug / strength (SCD) empagliflozin 10 MG / linagliptin 5 MGRxCUI 1602109empagliflozin 25 MG / linagliptin 5 MGRxCUI 1602118
Look up RxCUI 1598392 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 Empagliflozin / Linagliptin 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
Empagliflozin / Linagliptin belongs to the Dipeptidyl Peptidase 4 Inhibitor 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. Boehringer Ingelheim Pharmaceuticals, Inc. 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.