Note: This document contains side effect information about linagliptin. Some dosage forms listed on this page may not apply to the brand name Tradjenta.
Summary
More frequent side effects include: hypoglycemia. Continue reading for a comprehensive list of adverse effects.
Applies to linagliptin: oral tablet.
Serious side effects of Tradjenta
Along with its needed effects, linagliptin (the active ingredient contained in Tradjenta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking linagliptin:
More common
- Anxiety
- blurred vision
- chills
- cold sweats
- confusion
- cool, pale skin
- depression
- dizziness
- fast heartbeat
- headache
- increased hunger
- loss of consciousness
- nausea
- nightmares
- seizures
- shakiness
- slurred speech
- unusual tiredness or weakness
Incidence not known
- Bloating
- constipation
- cough
- fever
- hives, welts, itching, or skin rash
- large, hard skin blisters
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- severe joint pain
Other side effects of Tradjenta
Some side effects of linagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Muscle aches
- sore throat
- stuffy or runny nose
Less common
- Diarrhea
For Healthcare Professionals
Applies to linagliptin: oral tablet.
Gastrointestinal
During clinical trials, pancreatitis was reported in 15.2 cases per 10,000 patient year exposure in patients receiving linagliptin (the active ingredient contained in Tradjenta) 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]
Uncommon (0.1% to 1%): Constipation, increased amylase levels
Frequency not reported: Pancreatitis
Postmarketing reports: Acute pancreatitis[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
Dipeptidyl peptidase-4 inhibitors:
Postmarketing reports: Bullous pemphigoid[Ref]
Postmarketing reports of bullous pemphigoid requiring hospitalization have been reported with dipeptidyl peptidase-4 (DPP-4) inhibitors use. These case typically recovered with topical or systemic immunosuppressive treatment and discontinuation of DPP-4 inhibitor.[Ref]
Respiratory
Common (1% to 10%): Cough, nasopharyngitis, upper respiratory tract infection[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, extremity pain[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 (n=2), alogliptin (n=1), and vildagliptin (n=2).[Ref]
Nervous system
Common (1% to 10%): Headache[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
