Linagliptin: uses, dosing, side effects & brands
Linagliptin is a dipeptidyl peptidase 4 inhibitor sold in the U.S. under 2 brand and generic names, for type 2 diabetes mellitus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Dipeptidyl Peptidase 4 Inhibitor
- Treats
- Type 2 Diabetes Mellitus
- Available as
- Tablet
- Sold as
- 2 products — Tradjenta and Linagliptin
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 200 hours — the terminal (elimination) half-life at steady state, per the label
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How linagliptin is dosed
From the FDA label for Tradjenta (application NDA201280). Other linagliptin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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.
Linagliptin side effects
The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.4) ] Bullous Pemphigoid [see Warnings and Precautions (5.5) ] Heart Failure [see Warnings and Precautions (5.6) ] Most common adverse reaction (incidence ≥5% and more often than placebo) was nasopharyngitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety evaluation of TRADJENTA 5 mg once daily in patients with type 2 diabetes mellitus is based on 14 placebo-controlled trials, 1 active-controlled trial, and one trial in patients with severe renal impairment. In the 14 placebo-controlled studies, a total of 3,625 patients were randomized and treated with TRADJENTA 5 mg…
Who shouldn’t take linagliptin
TRADJENTA is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see Warnings and Precautions (5.3) and Adverse Reactions (6) ]. Hypersensitivity to linagliptin or any of the excipients in TRADJENTA ( 4 , 5.3 )
Linagliptin 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) ] .
Every linagliptin product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | No data | — | View → | |
| 2 | Not yet rated | Prescription | Tablet | No data | — | View → |
What linagliptin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| S75 | 5 mg | white | round | — |
| D5; | 5 mg | red | round | — |
Combination products containing linagliptin
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
How long linagliptin keeps
No linagliptin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does linagliptin expire? The in-use limits and storage rules from its labelsLinagliptin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for linagliptin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of linagliptin during breastfeeding. Linagliptin's plasma protein binding ranges from 80% to over 99%, so it is unlikely to pass into breastmilk in clinically important amounts and might be a better choice among drugs in this class for nursing mothers. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Monitor breastfed infants for signs of hypoglycemia such as jitteriness, excessive sleepiness, poor feeding, seizures cyanosis, apnea, or hypothermia. If there is concern, monitoring of the breastfed infant's blood glucose is advisable during maternal therapy with linagliptin.[1]
National Institute of Child Health and Human Development, record revised May 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about linagliptin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 9,561 reports naming linagliptin, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea804 reports
- dyspnoea756 reports
- nausea733 reports
- vomiting706 reports
- fatigue689 reports
- blood glucose increased680 reports
- pyrexia657 reports
- dizziness646 reports
Read these as a signal, not a rate. A report does not mean linagliptin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long linagliptin stays in your system
The elimination half-life of linagliptin is about 200 hours — the terminal (elimination) half-life at steady state, per the label. Read this number carefully: the label's headline terminal half-life is long only because of saturable binding to the target enzyme DPP-4, and the label explicitly says this prolonged elimination phase does NOT drive drug accumulation. The pharmacologically relevant figure for a once-daily drug is the effective (accumulation) half-life of about 11-12 hours; steady state is reached by the third dose with only ~1.3x accumulation. Plasma concentrations decline biphasically, so the ~200 h value is the terminal (beta) phase, not distribution. Not a prodrug. The one metabolite is pharmacologically INACTIVE (steady-state exposure ~13% of parent), so there is no active metabolite that outlasts the parent. Special populations: age, BMI, gender, and race have no clinically meaningful effect. Because linagliptin is ~90% excreted unchanged and only <5% renally, renal impairment (including severe) does not meaningfully change exposure and no dose adjustment is needed. Hepatic impairment (mild, moderate, or severe) gave comparable or slightly lower exposure — no clinically meaningful increase.
Tradjenta (linagliptin) tablets — FDA label, DailyMed, §12.3 Pharmacokinetics, Elimination ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is linagliptin?
TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme.
What kind of drug is linagliptin?
The FDA classifies linagliptin as a dipeptidyl peptidase 4 inhibitor. DPP-4 inhibitors block the enzyme that quickly destroys the body's own gut hormones (incretins like GLP-1). With these hormones lasting longer, the pancreas releases more insulin and less glucagon after meals, which lowers blood sugar. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does linagliptin stay in your system?
The elimination half-life of linagliptin is about 200 hours — the terminal (elimination) half-life at steady state, per the label — that is how long the body takes to clear half of a dose. Read this number carefully: the label's headline terminal half-life is long only because of saturable binding to the target enzyme DPP-4, and the label explicitly says this prolonged elimination phase does NOT drive drug accumulation. The pharmacologically relevant figure for a once-daily drug is the effective (accumulation) half-life of about 11-12 hours; steady state is reached by the third dose with only ~1.3x accumulation. Plasma concentrations decline biphasically, so the ~200 h value is the terminal (beta) phase, not distribution. Not a prodrug. The one metabolite is pharmacologically INACTIVE (steady-state exposure ~13% of parent), so there is no active metabolite that outlasts the parent. Special populations: age, BMI, gender, and race have no clinically meaningful effect. Because linagliptin is ~90% excreted unchanged and only <5% renally, renal impairment (including severe) does not meaningfully change exposure and no dose adjustment is needed. Hepatic impairment (mild, moderate, or severe) gave comparable or slightly lower exposure — no clinically meaningful increase. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take linagliptin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run linagliptin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is linagliptin sold under?
We track 2 linagliptin-containing products in the U.S.: Tradjenta and Linagliptin. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does linagliptin come in?
Across the brands we track, linagliptin is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic linagliptin?
Yes. Our catalog lists 1 generic linagliptin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Linagliptin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/linagliptin
- MLA
- “Linagliptin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/linagliptin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for linagliptin on DailyMed (NIH) ↗.