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Linagliptin (Tradjenta): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
5 mg
Brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Linagliptin

What is the most important information I should know about linagliptin tablets?

Linagliptin can cause serious side effects, including :

  • Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

    Before you start taking linagliptin tablets, tell your doctor if you have ever had:

  • inflammation of your pancreas (pancreatitis)
  • a history of alcoholism
  • stones in your gallbladder (gallstones)
  • high blood triglyceride levels
  • Stop taking linagliptin tablets and call your doctor 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 to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
  • Heart failure. Heart failure means your heart does not pump blood well enough.

    Before you start taking linagliptin tablets, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor 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
    • unusual tiredness

    These may be symptoms of heart failure.

What is linagliptin tablet?

  • linagliptin tablet is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • linagliptin tablet is not for people with type 1 diabetes.
  • linagliptin tablet is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
  • If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take linagliptin tablets.
  • It is not known if linagliptin tablet is safe and effective in children under 18 years of age.

Who should not take linagliptin tablets?

Do not take linagliptin tablets if you:

  • are allergic to linagliptin or any of the ingredients in linagliptin tablets. See the end of this Medication Guide for a complete list of ingredients in linagliptin tablets.

    Symptoms of a serious allergic reaction to linagliptin tablets may include:

    • skin rash, itching, flaking or peeling
    • raised red patches on your skin (hives)
    • swelling of your face, lips, tongue and throat that may cause difficulty in breathing or swallowing
    • difficulty with swallowing or breathing

If you have any of these symptoms, stop taking linagliptin tablets and call your doctor right away or go to the nearest hospital emergency room.

What should I tell my doctor before taking linagliptin tablets?

Before taking linagliptin tablets, tell your doctor about all of your medical conditions, including if you:

  • have or have had inflammation of your pancreas (pancreatitis).
  • are pregnant or plan to become pregnant. It is not known if linagliptin tablets will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.

  • are breastfeeding or plan to breastfeed. It is not known if linagliptin passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take linagliptin tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

linagliptin tablets may affect the way other medicines work, and other medicines may affect how linagliptin tablets work.

Especially tell your doctor if you take:

  • insulin or other medicines that can lower your blood sugar
  • rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take linagliptin tablets?

  • Take linagliptin tablets exactly as your doctor tells you to take it.
  • Take 1 tablet 1 time each day with or without food.

  • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of linagliptin tablets at the same time.
  • Your doctor may tell you to take linagliptin tablets along with other diabetes medicines. Low blood sugar can happen more often when linagliptin tablets are taken with certain other diabetes medicines. See " What are the possible side effects of linagliptin tablets?"
  • If you take too much linagliptin tablets, call your doctor or local poison control center or go to the nearest hospital emergency room right away.
  • Check your blood sugar as your doctor tells you to.

What are the possible side effects of linagliptin tablets?

linagliptin tablets may cause serious side effects, including:

  • See " What is the most important information I should know about linagliptin tablets?"
  • Low blood sugar (hypoglycemia). If you take linagliptin tablets 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 linagliptin tablets. Signs and symptoms of low blood sugar may include:
  • headache
  • irritability
  • drowsiness
  • hunger
  • weakness
  • fast heartbeat
  • dizziness
  • sweating
  • confusion
  • shaking or feeling jittery
  • Allergic (hypersensitivity) reactions. Serious allergic reactions have happened in people who are taking linagliptin tablets. Symptoms may include:
  • swelling of your face, lips, throat, and other areas on your skin
  • raised, red areas on your skin (hives)
  • difficulty with swallowing or breathing
  • skin rash, itching, flaking, or peeling
  • If you have any of these symptoms, stop taking linagliptin tablets and call your doctor right away or go to the nearest hospital emergency room.
  • Joint pain. Some people who take medicines called DPP-4 inhibitors like linagliptin tablets, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors like linagliptin tablets, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking linagliptin tablets.

The most common side effects of linagliptin tablets include stuffy or runny nose and sore throat, cough, and diarrhea.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of linagliptin tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store linagliptin tablets?

  • Store linagliptin tablets at room temperature between 68°F and 77°F (20°C and 25°C).

Keep linagliptin tablets and all medicines out of the reach of children.

General information about the safe and effective use of linagliptin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use linagliptin tablets for a condition for which it was not prescribed. Do not give linagliptin tablets to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about linagliptin tablets that is written for health professionals.

What are the ingredients in linagliptin tablets?

Active Ingredient: linagliptin

Inactive Ingredients: mannitol, pregelatinized starch, copovidone, and magnesium stearate. The film coating contains the following inactive ingredients: hypromellose, titanium dioxide, and polyethylene glycol.

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

Northern Industry Road 1#,

Song Shan Lake, DongGuan,

GuangDong Province, 523808,

P.R. China

Manufactured for:

HEC Pharm USA Inc.

13200 Townsend Road,

Philadelphia, PA 19154

The brands listed are trademarks of their respective owners and are not trademarks of HEC Pharm Co., Ltd. The makers of these brands are not affiliated with and do not endorse HEC Pharm Co., Ltd., or its products.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 208335 · View the label on DailyMed

Revision date stated in the text: August 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Linagliptin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Dipeptidyl Peptidase 4 Inhibitor
Active ingredient Linagliptin 5 mg
Dosage form Tablet, film coated
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) SUNSHINE
FDA approval ANDA 208335Abbreviated New Drug Application (ANDA) – generic drug Approved August 31, 2021
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Tradjenta with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg – 30 in 1 bottle NDC 48792-7865-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.