What is the most important information I should know about TRADJENTA?
TRADJENTA can cause serious side effects, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.
Stop taking TRADJENTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking TRADJENTA and call your healthcare provider right away or go to the nearest hospital emergency room.
What should I tell my healthcare provider before taking TRADJENTA?
Tell your healthcare provider about all your medical conditions, including if you have or have had inflammation of your pancreas (pancreatitis). Tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
What are the possible side effects of TRADJENTA?
TRADJENTA may cause serious side effects, including:
- Inflammation of the pancreas (pancreatitis).
- If you take TRADJENTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, fast heartbeat, sweating, shaking or feeling jittery.
- Allergic (hypersensitivity) reactions have happened in people who are taking TRADJENTA. Symptoms may include swelling of your face, lips, tongue, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); skin rash, itching, flaking, or peeling.
- Joint pain. Some people who take TRADJENTA may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.
- Skin Reaction. Some people who take medicines called DPP-4 inhibitors like TRADJENTA, may develop a skin reaction called bullous pemphigoid which can be serious and may need to be treated in a hospital. Tell your healthcare provider right away if you develop blisters.
- Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat, cough, and diarrhea.
These are not all the possible side effects of TRADJENTA. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
CL-TJ-100061 06.16.2023
