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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.

In Summary

More frequent side effects include: hypoglycemia. See below for a comprehensive list of adverse effects.

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.

Major Side Effects

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
Rare
  • 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

Minor Side Effects

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

Gastrointestinal

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]

General

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

Hypersensitivity

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]

Metabolic

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]

Dermatologic

Postmarketing reports: Rash, angioedema, urticaria[Ref]

Respiratory

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

Musculoskeletal

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]

Genitourinary

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

References

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: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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