Linagliptin / Metformin
Linagliptin/metformin is a two-ingredient 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 3 clinical label sets 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This medicine contains metformin, which can rarely cause a dangerous condition called lactic acidosis — a build-up of lactic acid in the blood that can be fatal. It has happened most often in people with kidney problems, but also in those with liver disease, heart failure, low oxygen levels, heavy alcohol use, or older age (65+). The warning signs can be subtle: unusual tiredness, muscle aches, stomach pain, difficulty breathing, feeling cold, or dizziness. If you notice these symptoms, stop taking the medicine and go to the hospital immediately — this is a medical emergency. Treatment includes stopping the drug and, if needed, dialysis to remove it from the body. Make sure your doctor knows about all your health conditions before you start this medicine.
📖 Linagliptin / Metformin: Patient Information Guide
A plain-language walkthrough of Linagliptin / Metformin — 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▾
Linagliptin/metformin is a combination medicine used to improve blood sugar control in adults with type 2 diabetes, always alongside diet and exercise.
- Jentadueto (tablet) is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Jentadueto XR (extended-release tablet) is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- None of these products is recommended for type 1 diabetes.
- None has been studied in people with a history of pancreatitis, so use in that group is uncertain.
⚙️How it works▾
This combination works through two distinct pathways. Linagliptin blocks an enzyme called DPP-4, which normally breaks down incretin hormones (GLP-1 and GIP). By protecting those hormones, linagliptin helps the pancreas release more insulin when blood sugar is elevated and tells the liver to produce less sugar. Metformin reduces the liver's output of glucose, slows glucose absorption from the intestines, and makes the body's cells more responsive to insulin — without pushing the pancreas to secrete extra insulin on its own.
💊How it's taken▾
Dosing is individualized by your prescriber based on how well your blood sugar is controlled and how well you tolerate the medicine. The dose is started low and increased gradually to minimize stomach upset from the metformin component.
- Jentadueto and linagliptin and metformin hydrochloride tablets are taken twice daily with meals.
- Jentadueto XR is taken once daily with a meal; tablets must be swallowed whole — never split, crushed, or chewed.
- Kidney function is checked before starting and regularly during treatment to guide dosing decisions.
- Follow your prescriber's exact instructions; do not adjust your dose on your own.
🤒Side effects — in detail▾
The most common side effects reported with linagliptin/metformin include:
- Stuffy or runny nose, sore throat (nasopharyngitis)
- Diarrhea
- Nausea or vomiting
- Stomach discomfort, indigestion, or gas
- Headache
- Decreased appetite
- Cough
More serious reactions — including lactic acidosis, pancreatitis, severe allergic reactions, severe joint pain, blistering skin (bullous pemphigoid), heart failure, and low blood sugar (when combined with insulin or sulfonylureas) — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these occur.
⚠️Warnings & precautions▾
- Lactic acidosis: The most critical risk. Metformin can rarely cause a dangerous and potentially fatal build-up of lactic acid. Risk is higher with kidney impairment, liver disease, heart failure, heavy alcohol use, age 65+, surgery, or imaging with contrast dye. Symptoms include unusual tiredness, muscle pain, stomach pain, trouble breathing, and dizziness — treat this as an emergency.
- Pancreatitis: Acute pancreatitis, including fatal cases, has been reported with linagliptin. Stop the medicine and seek care if you develop severe abdominal pain.
- Serious allergic reactions: Anaphylaxis (sudden severe allergic reaction), angioedema (swelling of face or throat), and serious skin reactions have occurred, sometimes after the very first dose.
- Low blood sugar (hypoglycemia): Risk increases if you also take a sulfonylurea or insulin. Your doctor may lower those doses when adding this medicine.
- Vitamin B12 deficiency: Metformin can reduce B12 absorption over time. Blood counts and B12 levels should be checked periodically.
- Severe joint pain: Disabling arthralgia has been reported; it may resolve when the medicine is stopped.
- Bullous pemphigoid: A blistering skin condition has been reported. Report any new blisters or skin erosions to your doctor promptly.
- Heart failure: An association between DPP-4 inhibitors and heart failure has been seen with other medicines in this class. Those with risk factors for heart failure should be monitored.
🔀What it interacts with▾
Several drugs, foods, and substances can interact with linagliptin/metformin in clinically meaningful ways:
- Alcohol: Heavy drinking amplifies metformin's effect on lactate metabolism, raising lactic acidosis risk — limit alcohol intake.
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide): These reduce bicarbonate levels and can increase lactic acidosis risk when combined with metformin.
- Drugs that reduce metformin clearance (e.g., ranolazine, dolutegravir, vandetanib, cimetidine): These can raise metformin blood levels, increasing lactic acidosis risk.
- Insulin or sulfonylureas (e.g., glipizide, glimepiride): Combining with linagliptin/metformin increases low blood sugar risk; dose reductions of those medicines may be needed.
- Strong P-gp or CYP3A4 inducers (e.g., rifampin): Can significantly lower linagliptin levels, reducing its effectiveness — alternative diabetes treatment may be recommended.
- Drugs that raise blood sugar (e.g., corticosteroids, thiazide diuretics, estrogens, oral contraceptives, phenytoin): May worsen blood sugar control; close monitoring is needed when starting or stopping these.
- Iodinated contrast dye (used in CT scans and other imaging): Can temporarily impair kidney function; the medicine may need to be stopped before and restarted only after kidney function is confirmed stable.
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 (eGFR below 30): Contraindicated — do not use.
- Moderate kidney impairment (eGFR 30–45): Starting this medicine is not recommended.
- Metabolic acidosis or diabetic ketoacidosis: Contraindicated — do not use.
- Allergy to linagliptin, metformin, or any ingredient: Contraindicated — do not use.
- Liver disease: Avoid use — impaired liver function raises lactic acidosis risk by reducing lactate clearance.
- Age 65 or older: Kidney function should be monitored more frequently; older adults are at higher risk for lactic acidosis.
- History of angioedema with another DPP-4 inhibitor: Use with caution — predisposition is unknown but possible.
- Pregnancy: Limited human data available; discuss risks and benefits with your doctor. Poorly controlled diabetes in pregnancy carries its own serious risks.
- Breastfeeding: Metformin is present in human milk. Discuss with your doctor whether to breastfeed or use this medicine.
- Premenopausal women not seeking pregnancy: Metformin may restore ovulation in some women who were not ovulating — discuss contraception with your doctor.
- Children and adolescents: Safety and effectiveness have not been established.
🚑If you take too much▾
If you or someone else takes too much of this medicine, call the Poison Help line (1-800-222-1222) or go to the emergency room. Metformin overdose has been associated with lactic acidosis in a meaningful portion of reported cases. Dialysis can help remove metformin from the body, but linagliptin is not effectively removed by dialysis.
📡Pharmacodynamics — effects in the body▾
Linagliptin reversibly inhibits DPP-4, raising levels of active incretin hormones (GLP-1 and GIP), which increase insulin release and lower glucagon in a blood-sugar-dependent way — meaning it works harder when blood sugar is high and eases off when levels normalize, reducing the risk of driving blood sugar too low on its own. Metformin lowers both fasting and after-meal blood sugar by reducing liver glucose output, slowing intestinal glucose absorption, and improving insulin sensitivity in peripheral tissues; it does this without prompting the pancreas to secrete more insulin. Studies of linagliptin have not shown any meaningful effect on heart rhythm (QTc interval) even at doses far above the standard therapeutic dose.
🔬Pharmacokinetics — how your body processes it▾
Linagliptin is about 30% absorbed after an oral dose, distributes widely into body tissues, and is largely excreted unchanged — metabolism plays only a minor role. It has a very long terminal half-life (over 100 hours) due to tight binding to DPP-4, but the clinically relevant accumulation half-life is about 12 hours, and steady-state levels are reached within three doses. Metformin is not metabolized by the liver and is cleared almost entirely by the kidneys, with a blood half-life of roughly 17–18 hours; because kidneys are the main exit route, reduced kidney function leads to metformin accumulation. For Jentadueto XR, taking the extended-release metformin component with food meaningfully increases metformin absorption, so it should consistently be taken with a meal.
📦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) . Protect from exposure to high humidity.
📄 Written from Linagliptin / Metformin’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 Linagliptin / Metformin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medicine doing for my diabetes? ▾
I've heard metformin can cause a serious problem with lactic acid. Should I be worried? ▾
Do I take this with food or can I take it on an empty stomach? ▾
Can I drink alcohol while taking this? ▾
I'm having a CT scan with contrast dye next week — do I need to stop this medicine? ▾
What side effects should I just expect versus ones that mean I need to call someone? ▾
Is Linagliptin / Metformin available over the counter? ▾
When was Linagliptin / Metformin first available? ▾
Who makes Linagliptin / Metformin? ▾
💬 Answers drafted from Linagliptin / Metformin’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 Linagliptin / Metformin comes
Linagliptin / Metformin is available in 2 forms. 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
- Jentadueto is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Linagliptin and metformin hydrochloride tablets are used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Jentadueto is taken twice daily with meals.
- Linagliptin and metformin hydrochloride tablets are taken twice daily with meals.
- Dose is increased gradually to reduce stomach side effects from metformin.
- May need to be stopped before imaging procedures that use iodinated contrast dye — follow your doctor's instructions.
Extended-release tablet
How this form is used
- Jentadueto XR is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Jentadueto XR is taken once daily with a meal.
- Jentadueto XR tablets must be swallowed whole — do not split, crush, dissolve, or chew them.
- Dose is increased gradually to reduce stomach side effects from metformin.
- Jentadueto XR may need to be stopped before imaging procedures that use iodinated contrast dye — follow your doctor's instructions.
📊 Linagliptin / Metformin across the U.S. market
How Linagliptin / Metformin 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.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are 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 Linagliptin / Metformin is used
A general measure of how commonly Linagliptin / Metformin 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 Linagliptin / Metformin 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 Linagliptin / Metformin prescribed? Of the 1,596 medications we measure, Linagliptin / Metformin ranks #602 by Medicaid prescriptions — more than 62% of them.
Utilization by Linagliptin / Metformin 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.
linagliptin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet Most dispensed
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1243020
24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1796089
linagliptin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1243027
24 HR linagliptin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1796094
linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1243034
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 Linagliptin / Metformin, 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 10 of 25 listed Linagliptin / Metformin NDCs with Medicaid activity.
🔍 Compare Linagliptin / Metformin products
A representative set of FDA-listed product records for Linagliptin / Metformin — 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 |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| LINAGLIPTIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 2.5; 1000 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 5; 1000 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | — | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| LINAGLIPTIN 5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | — | Patheon Pharmaceuticals Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Tablet | ||||
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 500 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 850 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 2.5; 500 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 2.5; 850 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 2.5; 1000 mg/1; mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 2.5 mg/500 mg | — | Boehringer Ingelheim Pharma GmbH and Co. KG | DRUG FOR FURTHER PROCESSING | View NDC → |
| METFORMIN HYDROCHLORIDE 850 mg/1; LINAGLIPTIN 2.5 mg | — | Boehringer Ingelheim Pharma GmbH and Co. KG | DRUG FOR FURTHER PROCESSING | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 500 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 850 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| LINAGLIPTIN 2.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
Showing 27 of 27 products — FDA National Drug Code Directory. See every product, package size and price: browse all 27 Linagliptin / Metformin 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 Linagliptin / Metformin — 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 Linagliptin / Metformin 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 Linagliptin / Metformin 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 1243019 2 dose forms · 5 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 1796088In current FDA listingsClinical drug / strength (SCD) 24 HR linagliptin 2.5 MG / metformin hydrochloride 1000 MGRxCUI 179608924 HR linagliptin 5 MG / metformin hydrochloride 1000 MGRxCUI 1796094 -
Dose form (SCDF) Oral Tablet RxCUI 1243018In current FDA listingsClinical drug / strength (SCD) linagliptin 2.5 MG / metformin hydrochloride 1000 MGRxCUI 1243020linagliptin 2.5 MG / metformin hydrochloride 500 MGRxCUI 1243027linagliptin 2.5 MG / metformin hydrochloride 850 MGRxCUI 1243034
Look up RxCUI 1243019 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 Linagliptin / Metformin 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
Linagliptin / Metformin 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 3 FDA-filed SPL label sets 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.