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Tradjenta (linagliptin) is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Tradjenta is used together with diet and exercise to treat type 2 diabetes. Linagliptin is not for treating type 1 diabetes.

Tradjenta may also be used for purposes not listed in this medication guide.

Important information

Do not use Tradjenta if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before you take Tradjenta, tell your doctor if you have high cholesterol or triglycerides, or a history of pancreatitis.

Stop taking Tradjenta and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heart rate.

Tradjenta is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Tradjenta is not for treating type 1 diabetes.

Before taking this medicine

You should not use Tradjenta if you are allergic to linagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Tradjenta is safe for you, tell your doctor if you have:

  • a history of pancreatitis; or

  • if you are using insulin or taking another oral diabetes medication.

FDA pregnancy category B. Tradjenta is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether linagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Tradjenta?

Take Tradjenta exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Tradjenta with or without food. Follow your doctor"s instructions.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor"s office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor"s advice.

Tradjenta is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor"s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity.

Tradjenta side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tradjenta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Tradjenta and call your doctor at once if you have:

  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, fast heart rate; or

  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Tradjenta side effects may include:

  • runny or stuffy nose, sore throat;

  • cough; or

  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Tradjenta?

Tell your doctor about all medications you use, and those you start or stop using during your treatment with Tradjenta, especially:

  • St. John"s wort;

  • HIV/AIDS medication--efavirenz, nevirapine, ritonavir (especially when given with tipranavir);

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

  • tuberculosis medication--rifabutin, rifampin, rifapentine.

Although Tradjenta is not as likely to cause hypoglycemia (low blood sugar) as some other oral diabetes medications, tell your doctor if you are taking any other drugs that can potentially lower blood sugar, such as:

  • aspirin or other salicylates (including Pepto-Bismol);

  • a blood thinner (warfarin, Coumadin);

  • sulfa drugs (Bactrim, SMZ-TMP, and others);

  • a monoamine oxidase inhibitor (MAOI); or

  • insulin or other oral diabetes medications, especially glipizide, glimepiride, glyburide, and others.

This list is not complete. Other drugs may interact with linagliptin, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.


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