Linagliptin
Linagliptin is a once-daily diabetes pill (a DPP-4 inhibitor) used with 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 →
Linagliptin (Tradjenta) is a once-daily type 2 diabetes medicine, often added to metformin and on the market since about 2011, that blocks an enzyme called DPP-4 so the body releases more insulin when blood sugar runs high and the liver releases less sugar. Most people tolerate it very well, and on its own it rarely causes low blood sugar or weight gain; a stuffy nose, sore throat or diarrhea is what some notice. The warning signs to know are severe, persistent stomach pain, which can mean pancreatitis (an inflamed pancreas), and swelling of the face, lips or throat, which can mean a serious allergic reaction; both need care right away.
Clinical pearls
- With insulin or a sulfonylurea such as glipizide, low blood sugar gets more likely, and that other dose may need lowering.
- Rifampin, the tuberculosis antibiotic, can make linagliptin work poorly, and the label strongly recommends a different diabetes medicine instead.
- Mention any heart failure or kidney problems, and report new shortness of breath, sudden weight gain or swelling promptly.
- It can be taken with or without food, works alongside diet and exercise, and is not effective for type 1 diabetes.
Patient information guide A plain-language walkthrough of Linagliptin, written from its FDA label.
What Linagliptin is used for
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Linagliptin is used to help control blood sugar in adults with type 2 diabetes.
- Tradjenta (oral tablet) is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Tradjenta is not recommended for type 1 diabetes, because it would not be effective.
- Tradjenta has not been studied in people with a history of pancreatitis.
How Linagliptin works
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Linagliptin is a DPP-4 inhibitor. It blocks the DPP-4 enzyme, which normally breaks down the gut hormones GLP-1 and GIP.
With more of these hormones active, your pancreas releases more insulin when blood sugar is high. They also lower glucagon, a hormone that tells the liver to release sugar.
Linagliptin dosage
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Tradjenta is a tablet taken by mouth once a day. It can be taken with or without food.
Follow your prescriber's directions and the label on your prescription.
Dosing details from the FDA-approved label
From the Linagliptin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (adults with type 2 diabetes mellitus, as stated in the dosing text)
- 5 mg taken orally once daily, with or without food
- Can be taken with or without food
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • The recommended dosage of TRADJENTA is 5 mg orally once daily ( 2.1 ) • TRADJENTA can be taken with or without food ( 2.1 ) 2.1 Recommended Dosage and Administration The recommended dosage of TRADJENTA is 5 mg taken orally once daily, with or without food.
Read the full Dosage and Administration section on DailyMed →
Linagliptin side effects
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Most people tolerate linagliptin well. Common side effects seen in studies include:
Common side effects
- Stuffy or runny nose and sore throat (nasopharyngitis)
- Diarrhea
- Cough
- Urinary tract infection (when combined with a sulfonylurea)
- Weight gain or high cholesterol/fats (when combined with pioglitazone)
- Constipation (when combined with basal insulin)
- Back pain, joint pain or headache (seen in a longer trial with metformin)
When to get medical help
- Severe, persistent stomach pain, with or without vomiting, could signal pancreatitis. Call your doctor right away.
- Swelling of the face, lips, tongue or throat, trouble breathing, hives or peeling skin could be a serious allergic reaction. Get emergency help.
- Blisters or skin erosions could be bullous pemphigoid. Tell your doctor promptly.
- Severe or disabling joint pain should be reported to your prescriber.
- Shortness of breath, sudden weight gain or swelling could be signs of heart failure. Report them right away.
- Shakiness, sweating, confusion or other signs of low blood sugar, especially if you also take insulin or a sulfonylurea.
Linagliptin warnings and precautions
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- Pancreatitis: Cases, including fatal ones, have been reported. Stop the drug and call your doctor if you have severe, lasting stomach pain.
- Serious allergic reactions: These include anaphylaxis, angioedema and peeling skin. They mostly happened in the first 3 months, and sometimes after the first dose.
- Low blood sugar: Risk rises when combined with insulin or a sulfonylurea. Doses of those drugs may need to be lowered.
- Severe joint pain: It can start days or years after beginning the drug, and eased after stopping.
- Bullous pemphigoid: This blistering skin condition has required hospitalization. Report any blisters or erosions.
- Heart failure: Seen with other drugs in this class. People with prior heart failure or kidney problems should be watched closely.
Linagliptin interactions
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A few medicines can change how linagliptin works or add to its effects.
- Rifampin and other strong P-gp or CYP3A4 inducers: they lower linagliptin levels, so it may work less well. Alternatives are strongly recommended.
- Insulin: raises the risk of low blood sugar, so the insulin dose may need to be lowered.
- Sulfonylureas and other insulin secretagogues: raise the risk of low blood sugar, so their dose may need to be lowered.
Interactions listed in the FDA-approved label
From the Linagliptin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong P-glycoprotein (P-gp) or CYP3A4 inducers (e.g., rifampin): Rifampin decreased linagliptin exposure, suggesting that the efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Use of alternative treatments is strongly recommended.
- Insulin secretagogues (e.g., sulfonylurea) or insulin: The risk of hypoglycemia is increased when linagliptin is used in combination with an insulin secretagogue or insulin. Coadministration may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Read the label’s full interactions text
7 DRUG INTERACTIONS Strong P-glycoprotein/CYP3A4 inducer: The efficacy of TRADJENTA may be reduced when administered in combination (e.g., with rifampin). Use of alternative treatments is strongly recommended. ( 7.1 ) 7.1 Inducers of P-glycoprotein or CYP3A4 Enzymes Rifampin decreased linagliptin exposure, suggesting that the efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer [see Clinical Pharmacology (12.3) ] . 7.2 Insulin Secretagogues or Insulin Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when linagliptin is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin. Coadministration of TRADJENTA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.2) ] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Linagliptin
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- Do not use it if you are allergic to linagliptin or any ingredient in the tablet.
- Tell your doctor if you have had pancreatitis.
- Use caution if you have had angioedema with another DPP-4 inhibitor.
- Tell your doctor about heart failure or kidney problems.
- Pregnancy: data are too limited to know the risk, and poorly controlled diabetes carries its own risks.
- Breastfeeding: it is unknown whether it passes into human milk, so weigh benefits and risks with your doctor.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen.
- Kidney problems: no dose adjustment is recommended.
Linagliptin overdose
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If you take too much Tradjenta, consider calling the Poison Help Line at 1-800-222-1222 or a medical toxicologist for advice. Dialysis is unlikely to remove linagliptin from the body.
What Linagliptin does in the body
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Linagliptin binds reversibly to DPP-4 and raises levels of incretin hormones. This increases insulin release and lowers glucagon in a glucose-dependent way. It selectively blocks DPP-4, not the related enzymes DPP-8 or DPP-9. In a study of healthy people, it did not lengthen the QTc interval (a heart rhythm measure), even at 20 times the recommended dose.
How your body processes Linagliptin
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After a tablet is swallowed, blood levels peak in about 1.5 hours. About 30% of the drug is absorbed, and food does not meaningfully change this. Steady levels are reached by the third once-daily dose.
Most linagliptin leaves the body unchanged, and only a small amount is metabolized. It is cleared mainly through the gut and bile, with a small amount in urine.
How to store Linagliptin
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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 the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Linagliptin
284 supplements and herbal products have documented interactions with Linagliptin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 240
- Minor · 41
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.
Nutrient depletion considerations
Linagliptin 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.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Linagliptin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Linagliptin — the kind of thing our pharmacy team would talk through with you at the counter.
What is linagliptin for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I take it with my other diabetes medicines?
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Is it safe during pregnancy or breastfeeding?
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Is Linagliptin available over the counter?
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When was Linagliptin first available?
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Who makes Linagliptin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Linagliptin on HelloPharmacist
Linagliptin forms and strengths (how it comes)
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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Linagliptin inactive ingredients by manufacturer.
Tablet
How this form is used
- Tradjenta is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- Tradjenta is not recommended for type 1 diabetes.
- Tradjenta is taken by mouth once daily.
- Tradjenta can be taken with or without food.
Linagliptin on the U.S. market: products, makers and brands
How 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.
3 companies list 3 Linagliptin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Tradjenta; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Linagliptin is used (Medicaid data)
A general measure of how commonly 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 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 Linagliptin prescribed? Of the 1,601 medications we measure, Linagliptin ranks #418 by Medicaid prescriptions — more than 74% of them.
Utilization by 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.
linagliptin 5 MG Oral Tablet
Summed across the 3 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1100702
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, 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 3 of 7 listed Linagliptin NDCs with Medicaid activity.
Compare Linagliptin products
A representative set of FDA-listed product records for 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 | ||||
| 5 mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| 5 mg | Oral | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | View NDC → |
| 5 mg | Oral | Cardinal Health 107, LLC | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Linagliptin NDCs →
Linagliptin side effects reported to the 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 — 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 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.
Linagliptin FDA approval history
How Linagliptin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Linagliptin 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.
The FDA’s enforcement reports list no Linagliptin recalls since July 2021.
✅No Linagliptin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 1100699 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 1100701In current FDA listingsClinical drug / strength (SCD) 5 MGRxCUI 1100702
Look up RxCUI 1100699 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.
Linagliptin supply and shortage status
Whether 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.
💵 What Linagliptin costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 5 mg | $16.80 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Linagliptin brand names
Linagliptin is sold under one brand name in the FDA directory — Tradjenta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Linagliptin: manufacturers and labelers
3 companies list Linagliptin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Boehringer Ingelheim Pharmaceuticals, Inc., Cardinal Health 107, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Linagliptin drug class (RxNorm)
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.
Sources for this Linagliptin 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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cardinal Health 107, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →