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Jentadueto XR Side Effects

Generic name: linagliptin / metformin

Medically reviewed by Last updated on May 14, 2022.

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.


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


Oral route (Tablet; Tablet, Extended Release)

Lactic acidosis can occur due to metformin accumulation during treatment with linagliptin / metformin hydrochloride, and case reports of death, hypothermia, hypotension, and resistant bradyarrhythmias have been reported. The risk of lactic acidosis is increased with renal impairment, concomitant cationic drugs (eg, topiramate), age 65 years or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Onset is often subtle with symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities include elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally greater than 5 mcg/mL. If lactic acidosis is suspected, immediately discontinue therapy, hospitalize patient, and promptly start hemodialysis.

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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


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


Frequency not reported: Hypoglycemia


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


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



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

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

Postmarketing reports: Mouth ulceration


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

Frequency not reported: Pancreatitis

Postmarketing reports: Acute pancreatitis, including fatal pancreatitis, stomatitis


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

Common (1% to 10%): Constipation

Frequency not reported: Flatulence, indigestion[Ref]

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]


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]


Rare (less than 0.1%): Drug hypersensitivity


Postmarketing reports: Serious hypersensitivity reactions[Ref]



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

Uncommon (0.1% to 1%): Cough


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


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


Uncommon (0.1% to 1%): Pruritus

Postmarketing reports: Angioedema, urticaria, rash


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


Postmarketing reports: Bullous pemphigoid[Ref]



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



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

Postmarketing reports: Cholestatic, hepatocellular, and mixed hepatocellular liver injury[Ref]



Frequency not reported: Myalgia, arthralgia

Postmarketing reports: Severe and disabling arthralgia, rhabdomyolysis[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%): Taste disturbance[Ref]



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



Common (1% to 10%): Headache


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


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

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

3. "Product Information. Jentadueto (linagliptin-metformin)." Boehringer Ingelheim (2012):

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." (2015):

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.