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Tradjenta Side Effects

Generic Name: linagliptin

Note: This page contains side effects data for the generic drug linagliptin. It is possible that some of the dosage forms included below may not apply to the brand name Tradjenta.

It is possible that some side effects of Tradjenta may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to linagliptin: oral tablet

As well as its needed effects, linagliptin (the active ingredient contained in Tradjenta) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking linagliptin, check with your doctor immediately:

More common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • nausea
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
  • Bloating
  • constipation
  • darkened urine
  • fever
  • indigestion
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • vomiting
  • yellow eyes or skin
Incidence not known
  • Flaking and falling off of the skin
  • hives or welts
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • skin rash

Some linagliptin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • difficulty with moving
  • muscle aches
  • muscle pain or stiffness
  • pain in the joints
  • sore throat
  • stuffy or runny nose
Less common
  • Cough
  • weight gain

For Healthcare Professionals

Applies to linagliptin: oral tablet


Uncommon (0.1% to 1%): Constipation, increased amylase levels
Frequency not reported: Pancreatitis
Postmarketing reports: Acute pancreatitis[Ref]

During clinical trials, pancreatitis was reported in 15.2 cases per 10,000 patient year exposure in patients receiving linagliptin compared with 3.7 cases per 10,000 patient year exposure in those receiving active comparator (sulfonylurea). Following completion of clinical trials, 3 additional cases of pancreatitis were reported among those receiving linagliptin. Postmarketing reports of acute pancreatitis, including fatalities, have been received.[Ref]


The most common adverse event reported was nasopharyngitis.[Ref]


Frequency not reported: Drug hypersensitivity
Postmarketing reports: Serious hypersensitivity reactions[Ref]

Serious hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions have been reported postmarketing in patients treated with this drug. These reactions have occurred within the first 3 months, with some occurring after the first dose.[Ref]


The incidence of hypoglycemia in patients treated with this drug as monotherapy, or in combination with metformin or pioglitazone, was similar to the incidence observed in placebo-treated patients. When given in combination with metformin plus a sulfonylurea, the incidence of hypoglycemia was almost 23% compared to 15% in those receiving placebo with metformin plus a sulfonylurea. As add-on to stable insulin therapy, the incidence of hypoglycemia was similar to placebo (31.4% versus 32.9%).[Ref]

Common (1% to 10%): Hypoglycemia, hypertriglyceridemia, hyperlipidemia, increased uric acid[Ref]


Postmarketing reports: Rash, angioedema, urticaria[Ref]


Common (1% to 10%): Cough, nasopharyngitis, upper respiratory tract infection[Ref]


Between October 2006 and December 2013, thirty-three cases of severe arthralgia have been reported to the FDA Adverse Event Reporting System Database. Each case involved the use of 1 or more dipeptidyl peptidase-4 (DPP-4) inhibitor. In all cases, substantial reduction in prior activity level was reported, 10 patients were hospitalized due to disabling joint pain. In 22 cases, symptoms appeared within 1 month of starting therapy, in 23 cases symptoms resolved less than 1 month after discontinuation. A positive rechallenge was reported in 8 cases, with 6 cases involving use of a different DPP-4 inhibitor. Sitagliptin had the greatest number of cases reported (n=28) followed by saxagliptin (n=5), linagliptin (the active ingredient contained in Tradjenta) (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]

Common (1% to 10%): Back pain, arthralgia, extremity pain[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


1. "Product Information. Tradjenta (linagliptin)." Boehringer Ingelheim, Ridgefield, CT.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. US Food and Drug Administration "FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. Available from: URL:" ([2015, Aug 28]):

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