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Jentadueto XR Side Effects

Generic Name: linagliptin / metformin

Note: This document contains side effect information about linagliptin / metformin. Some of the dosage forms listed on this page may not apply to the brand name Jentadueto XR.

In Summary

Common side effects of Jentadueto XR include: lactic acidosis and hypoglycemia. Other side effects include: decreased vitamin b12 serum concentrate. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to linagliptin / metformin: oral tablet, oral tablet extended release

Along with its needed effects, linagliptin/metformin 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 / metformin:

Less Common

Incidence Not Known

  • Bloating
  • constipation
  • darkened urine
  • fainting spells
  • fever
  • indigestion
  • irregular heartbeat
  • 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
  • severe joint pain
  • vomiting
  • yellow eyes or skin

Some side effects of linagliptin / metformin 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

Incidence Not Known

  • Cough
  • decreased appetite
  • difficulty with moving
  • flaking and falling off of the skin
  • hives or welts, itching, or skin rash
  • muscle aching or cramping
  • muscle pains or stiffness
  • redness of the skin
  • swollen joints

For Healthcare Professionals

Applies to linagliptin / metformin: oral tablet, oral tablet extended release

General

The most commonly reported adverse events included nasopharyngitis and diarrhea.[Ref]

Metabolic

Linagliptin-Metformin:

Frequency not reported: Hypoglycemia

Linagliptin:

Common (1% to 10%): Hypertriglyceridemia, hyperlipidemia, weight increased

Metformin:

Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency[Ref]

Hypoglycemia was more commonly reported in patients receiving the combination linagliptin / metformin plus a sulfonylurea compared with those receiving metformin plus a sulfonylurea (22.9% vs 14.8%; n=792).[Ref]

Gastrointestinal

Gastrointestinal events such as nausea, vomiting, diarrhea, decreased appetite, and abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in most cases.

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]

Linagliptin-Metformin:

Common (1% to 10%): Decreased appetite, diarrhea, nausea, vomiting

Uncommon (0.1% to 1%): Increased blood amylase

Postmarketing reports: Mouth ulceration

Linagliptin:

Common (1% to 10%): Constipation, diarrhea

Frequency not reported: Pancreatitis

Metformin:

Very common (10% or more): Diarrhea, nausea, vomiting, abdominal pain, decreased appetite

Common (1% to 10%): Constipation

Frequency not reported: Flatulence, indigestion[Ref]

Hypersensitivity

Linagliptin-Metformin:

Rare (less than 0.1%): Drug hypersensitivity

Linagliptin

Postmarketing reports: Serious hypersensitivity reactions[Ref]

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

Respiratory

Linagliptin-Metformin

Common (1% to 10%): Nasopharyngitis (6.3%),

Uncommon (0.1% to 1%): Cough

Linagliptin

Common (1% to 10%): Nasopharyngitis, cough

Metformin

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

Dermatologic

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]

Linagliptin-Metformin:

Uncommon (0.1% to 1%): Pruritus

Postmarketing reports: Angioedema, urticaria, rash

Metformin:

Very rare (less than 0.01%): Skin reactions such as erythema, pruritus, and urticaria

Dipeptidyl peptidase-4 inhibitors:

Postmarketing reports: Bullous pemphigoid[Ref]

Hematologic

Metformin

Very rare (less than 0.01%): Megaloblastic anemia[Ref]

Hepatic

Metformin:

Very rare (less than 0.01%): Hepatitis, liver function test abnormalities[Ref]

Musculoskeletal

Linagliptin:

Frequency not reported: Myalgia, arthralgia[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

Metformin:

Common (1% to 10%): Taste disturbance[Ref]

Genitourinary

Linagliptin:

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

Psychiatric

Linagliptin:

Common (1% to 10%): Headache

Metformin:

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

References

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

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

3. "Product Information. Jentadueto (linagliptin-metformin)." Boehringer Ingelheim, Ridgefield, CT.

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]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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