What is Tradjenta (linagliptin)?
Tradjenta (linagliptin) is an oral diabetes medicine that is combined with diet and exercise to improve blood glucose levels in patients with type 2 diabetes. It should not be used for treating type 1 diabetes or diabetic ketoacidosis because it would not be effective in these conditions.
Common side effects of Tradjenta include:
- stuffy or runny nose,
- sore throat,
- allergic reactions,
- muscle pain,
- increased uric acid levels, and
Serious side effects of Tradjenta include:
Other drugs that increase activity CYP3A4 may also reduce the blood concentration of Tradjenta.
What are the side effects of Tradjenta (linagliptin)?
The most common side effects of Tradjenta are:
- Stuffy or runny nose
- Sore throat
- Allergic reactions
- Muscle pain
- Increased uric acid levels
Hypoglycemia may occur when Tradjenta is combined with insulin or a sulfonylurea-type drug.
Possible serious side effects include:
- Severe joint pain
- Severe allergic reactions (anaphalaxis)
Tradjenta (linagliptin) side effects list for healthcare professionals
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 is based on 14 placebo-controlled trials, 1 active-controlled study, and one study in patients with severe renal impairment. In the 14 placebo-controlled studies, a total of 3625 patients were randomized and treated with Tradjenta 5 mg daily and 2176 with placebo. The mean exposure in patients treated with Tradjenta across studies was 29.6 weeks. The maximum follow-up was 78 weeks.
Tradjenta 5 mg once daily was studied as monotherapy in three placebo-controlled trials of 18 and 24 weeks’ duration and in five additional placebo-controlled studies lasting ≤18 weeks. The use of Tradjenta in combination with other antihyperglycemic agents was studied in six placebo-controlled trials: two with metformin (12 and 24 weeks’ treatment duration); one with a sulfonylurea (18 weeks’ treatment duration); one with metformin and sulfonylurea (24 weeks’ treatment duration); one with pioglitazone (24 weeks’ treatment duration); and one with insulin (primary endpoint at 24 weeks).
In a pooled dataset of 14 placebo-controlled clinical trials, adverse reactions that occurred in ≥2% of patients receiving Tradjenta (n = 3625) and more commonly than in patients given placebo (n = 2176), are shown in Table 1. The overall incidence of adverse events with Tradjenta were similar to placebo.
Table 1: Adverse Reactions Reported in ≥2% of Patients Treated with Tradjenta and Greater than Placebo in Placebo-Controlled Clinical Studies of Tradjenta Monotherapy or Combination Therapy
|Number (%) of Patients|
|Tradjenta 5 mg|
n = 3625
n = 2176
|Nasopharyngitis||254 (7.0)||132 (6.1)|
|Diarrhea||119 (3.3)||65 (3.0)|
|Cough||76 (2.1)||30 (1.4)|
Rates for other adverse reactions for Tradjenta 5 mg vs placebo when Tradjenta was used in combination with specific anti-diabetic agents were: urinary tract infection (3.1% vs 0%) and hypertriglyceridemia (2.4% vs 0%) when Tradjenta was used as add-on to sulfonylurea; hyperlipidemia (2.7% vs 0.8%) and weight increased (2.3% vs 0.8%) when Tradjenta was used as add-on to pioglitazone; and constipation (2.1% vs 1%) when Tradjenta was used as add-on to basal insulin therapy.
Following 104 weeks’ treatment in a controlled study comparing Tradjenta with glimepiride in which all patients were also receiving metformin, adverse reactions reported in ≥5% of patients treated with Tradjenta (n = 776) and more frequently than in patients treated with a sulfonylurea (n = 775) were back pain (9.1% vs 8.4%), arthralgia (8.1% vs 6.1%), upper respiratory tract infection (8.0% vs 7.6%), headache (6.4% vs 5.2%), cough (6.1% vs 4.9%), and pain in extremity (5.3% vs 3.9%).
Other adverse reactions reported in clinical studies with treatment of Tradjenta were hypersensitivity (e.g., urticaria, angioedema, localized skin exfoliation, or bronchial hyperreactivity) and myalgia. In the clinical trial program, pancreatitis was reported in 15.2 cases per 10,000 patient year exposure while being treated with Tradjenta compared with 3.7 cases per 10,000 patient year exposure while being treated with comparator (placebo and active comparator, sulfonylurea). Three additional cases of pancreatitis were reported following the last administered dose of linagliptin.
In the placebo-controlled studies, 199 (6.6%) of the total 2994 patients treated with Tradjenta 5 mg reported hypoglycemia compared to 56 patients (3.6%) of 1546 placebo-treated patients. The incidence of hypoglycemia was similar to placebo when Tradjenta was administered as monotherapy or in combination with metformin, or with pioglitazone.
When Tradjenta was administered in combination with metformin and a sulfonylurea, 181 of 792 (22.9%) patients reported hypoglycemia compared with 39 of 263 (14.8%) patients administered placebo in combination with metformin and a sulfonylurea. Adverse reactions of hypoglycemia were based on all reports of hypoglycemia. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is not possible to conclusively determine that all these reports reflect true hypoglycemia.
In the study of patients receiving Tradjenta as add-on therapy to a stable dose of insulin for up to 52 weeks (n=1261), no significant difference in the incidence of investigator reported hypoglycemia, defined as all symptomatic or asymptomatic episodes with a self-measured blood glucose ≤70 mg/dL, was noted between the Tradjenta-(31.4%) and placebo-(32.9%) treated groups.
During the same time period, severe hypoglycemic events, defined as requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, were reported in 11 (1.7%) of Tradjenta treated patients and 7 (1.1%) of placebo treated patients. Events that were considered life-threatening or required hospitalization were reported in 3 (0.5%) patients on Tradjenta and 1 (0.2%) on placebo.
Use In Renal Impairment
Tradjenta was compared to placebo as add-on to pre-existing antidiabetic therapy over 52 weeks in 133 patients with severe renal impairment (estimated GFR <30 mL/min). For the initial 12 weeks of the study, background antidiabetic therapy was kept stable and included insulin, sulfonylurea, glinides, and pioglitazone. For the remainder of the trial, dose adjustments in antidiabetic background therapy were allowed.
In general, the incidence of adverse events including severe hypoglycemia was similar to those reported in other Tradjenta trials. The observed incidence of hypoglycemia was higher (Tradjenta, 63% compared to placebo, 49%) due to an increase in asymptomatic hypoglycemic events especially during the first 12 weeks when background glycemic therapies were kept stable.
Ten Tradjenta-treated patients (15%) and 11 placebo-treated patients (17%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying finger stick glucose ≤54 mg/dL). During the same time period, severe hypoglycemic events, defined as an event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, were reported in 3 (4.4%) Tradjenta-treated patients and 3 (4.6%) placebo-treated patients. Events that were considered life-threatening or required hospitalization were reported in 2 (2.9%) patients on Tradjenta and 1 (1.5%) patient on placebo.
Renal function as measured by mean eGFR and creatinine clearance did not change over 52 weeks’ treatment compared to placebo.
Changes in laboratory findings were similar in patients treated with Tradjenta 5 mg compared to patients treated with placebo.
Increase in Uric Acid
Changes in laboratory values that occurred more frequently in the Tradjenta group and ≥1% more than in the placebo group were increases in uric acid (1.3% in the placebo group, 2.7% in the Tradjenta group).
Increase in Lipase
In a placebo-controlled clinical trial with Tradjenta in type 2 diabetes mellitus patients with micro-or macroalbuminuria, a mean increase of 30% in lipase concentrations from baseline to 24 weeks was observed in the Tradjenta arm compared to a mean decrease of 2% in the placebo arm. Lipase levels above 3 times upper limit of normal were seen in 8.2% compared to 1.7% patients in the Tradjenta and placebo arms, respectively.
No clinically meaningful changes in vital signs were observed in patients treated with Tradjenta.
Additional adverse reactions have been identified during postapproval use of Tradjenta. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
What drugs interact with Tradjenta (linagliptin)?
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.
Tradjenta (linagliptin) is an oral diabetes medicine that is combined with diet and exercise to improve blood glucose levels in patients with type 2 diabetes. It should not be used for treating type 1 diabetes or diabetic ketoacidosis because it would not be effective in these conditions. Common side effects of Tradjenta include stuffy or runny nose, sore throat, allergic reactions, muscle pain, diarrhea, increased uric acid levels, and cough. Low blood sugar (hypoglycemia) may occur when Tradjenta is combined with insulin or a sulfonylurea-type drug. Drug interactions of Tradjenta include rifampin, which decreases the blood concentration of Tradjenta by stimulating breakdown of Tradjenta by CYP3A4 liver enzymes. There are no adequate studies of Tradjenta in pregnant women. It is unknown if Tradjenta is secreted in human breast milk. Consult your doctor before breastfeeding.
Multimedia: Slideshows, Images & Quizzes
Type 2 Diabetes: Signs, Symptoms, Treatments
Learn about type 2 diabetes warning signs, symptoms, diagnosis, and treatment options. Find out why thirst, headaches, and...
Diabetes: What Raises and Lowers Your Blood Sugar Level?
Want to lower your blood sugar? Learn to better control your glucose levels by preventing blood sugar spikes and swings to avoid...
Diabetes Nerve Pain: Improving Diabetic Peripheral Neuropathy
Learn how to cope with the symptoms of diabetic peripheral neuropathy through pain management exercises. Find relief for diabetic...
Diabetes: How Blood Sugar Levels Affect Your Body
High blood sugar can be a sign of diabetes or prediabetes. The drugs that treat it sometimes cause low blood sugar too. WebMD...
Foot Health: Reasons You Feel Burning in Your Feet
The feeling of burning in your feet isn't just an annoyance. It might also be a sign of a more serious condition. Find out more...
Diabetes Tips: Managing and Living With Diabetes
If you have either type 1 or type 2 diabetes, you need to approach life differently. Learn nutrition tips to control blood sugar,...
How Diabetes Can Affect Your Feet
Learn more about diabetes related foot problems. For people with diabetes, too much glucose in the blood can cause serious foot...
Diabetes: 12 Ways Too Much Sugar Harms Your Body
The bitter truth: How too much sugar can harm your physical and mental health.
Diabetes Diet: Healthy Meal Plans for Diabetes-Friendly Eating
Discover the best and worst meals for diabetes-savvy dining. See how to avoid carbs and control your blood sugar with healthier...
Type 2 Diabetes: Test Your Medical IQ
What causes type 2 diabetes? Can it be prevented? Take this online quiz and challenge your knowledge of this common condition....
Diabetes Quiz: Test Your Medical IQ
Take the Diabetes Quiz and learn the causes, signs, symptoms, and types of this growing epidemic. What does diabetes have to do...
Diabetes Travel: Tips for Better Diabetes Control
Diabetes shouldn't stop you from traveling! Learn tips for packing diabetic supplies, controlling blood sugar while changing time...
Diabetes Diet: 11 Low-Sugar Drink Ideas
Searching for low-sugar drink ideas? This pictures slideshow has eleven beverages ideal for people with diabetes and those...
Diabetes: 15 Famous Celebrities With Diabetes
See pictures of celebrities that have been diagnosed with type 1 or type 2 diabetes including Mary Tyler Moore, Salma Hayek, and...
Slideshow: Diabetes Management in 10 Minutes
Learn 10 simple ways to better manage your diabetes. See tips for controlling blood sugar, diet and exercise and other helpful...
Diabetes: Guide to Diabetic Peripheral Neuropathy
Diabetes can damage the nerves that help you feel pain, heat, and cold, especially in your feet. Learn about the symptoms of...
10 Muscle-Building Exercises for Diabetes
Watch this slideshow on Diabetes and Exercise. If you have diabetes, see how strengthening your muscles with these 10 weight...
Diabetes: Diabetic Peripheral Neuropathy Treatment
This nerve damage is a common complication of both type 1 and type 2 diabetes. Find out how to prevent it, slow its progression,...
Related Disease Conditions
Normal Blood Sugar Levels In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Diabetes-Related Dental Problems
Second Source WebMD Medical Reference
Type 2 Diabetes: Diagnosing Diabetes
Second Source WebMD Medical Reference
Second Source WebMD Medical Reference
Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
Diabetes Symptoms in Men
Early symptoms of diabetes are different in men, such as low testosterone. In many cases, prediabetes that will progress to type 2 diabetes if it is not treated early.
Prediabetes is a situation where a person's blood sugar levels are higher than they should be, but aren't high enough to be diagnosed with type 2 diabetes. There are no signs or symptoms of prediabetes. Some of the risk factors for prediabetes are high blood pressure, high cholesterol, heart disease, smoking, family history, poor diet, and lack of activity. Diet changes along with other healthy lifestyle changes are important in treating prediabetes.
Type 1 vs. Type 2 Diabetes: Differences
Diabetes mellitus is a metabolic condition in which a person's blood sugar (glucose) levels are too high. Over 29.1 million children and adults in the US have diabetes. Of that, 8.1 million people have diabetes and don't even know it. Type 1 diabetes (insulin-dependent, juvenile) is caused by a problem with insulin production by the pancreas. Type 2 diabetes (non-insulin dependent) is caused by: Eating a lot of foods and drinking beverages with simple carbohydrates (pizza, white breads, pastas, cereals, pastries, etc.) and simple sugars (donuts, candy, etc.) Consuming too many products with artificial sweeteners (We found out that they are bad for us!) Lack of activity Exercise Stress Genetics While the signs and symptoms of both types of diabetes are the same, which include: Increased urination Increased hunger Increased thirst Unexplained weight loss. However, the treatments are different. Type 1 diabetes is insulin dependent, which means a person with this type of diabetes requires treatment with insulin. People with type 2 diabetes require medication, lifestyle changes like eating a healthy diet, and getting regular exercise.
Diabetes and Safe Medications for Colds & Flu
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
Diabetes Foot Problems
Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
Treatment & Diagnosis
- Diabetes FAQs
- Type 2 Diabetes FAQs
- What if I get COVID-19 with Diabetes?
- Diabetes - An Aspirin A Day
- Diabetes and Eye Disease...See No Evil
- Diabetes - David Meets Goliath
- Insulin...Getting Better All the Time
- Insulin Resistance - Keypoints
- Ramipril, Heart Disease, Stroke & Diabetes
- Heart Disease Stroke and Diabetes
- Hypoglycemia (Low Blood Sugar) Symptoms and Diabetes
- Rheumatoid Arthritis & Diabetes Gene (PTPN22)
- What Foods to Eat to Reverse Diabetes
- Can You Get Diabetes from Stress?
- How Do You Know if You Have Diabetes?
- Can oral diabetes medications cause impotence?
- What Is the Treatment for Diabetes Eye Damage?
- 6 Frequently Asked Diabetes Question
- What Kind of Candy Can You Eat With Diabetes?
- Is Weight Loss Caused by Diabetes Dangerous?
- Can Diabetes Cause Muscle Pain?
- 11 Diabetes Diet Tips for the Holidays
- Diabetes Diet
- Top 10 Questions to Ask Your Doctor About Diabetes
- Prediabetes Symptoms and Diagnosis
- Diabetes: Eating Well with Type 2 Diabetes
- Diabetes: What Can I Eat?
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.