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.
Common side effects of Jentadueto include: lactic acidosis and hypoglycemia. Other side effects include: decreased vitamin b12 serum concentrate. See below for a comprehensive list of adverse effects.
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.
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:
Incidence not known
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:
Incidence not known
Applies to linagliptin / metformin: oral tablet, oral tablet extended release
The most commonly reported adverse events included nasopharyngitis and diarrhea.
Frequency not reported: Hypoglycemia
Common (1% to 10%): Hypertriglyceridemia, hyperlipidemia, weight increased
Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency
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).
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.
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
Very common (10% or more): Diarrhea, nausea, vomiting, abdominal pain, decreased appetite
Common (1% to 10%): Constipation
Frequency not reported: Flatulence, indigestion
Rare (less than 0.1%): Drug hypersensitivity
Postmarketing reports: Serious hypersensitivity reactions
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.
Common (1% to 10%): Nasopharyngitis (6.3%),
Uncommon (0.1% to 1%): Cough
Common (1% to 10%): Nasopharyngitis, cough
Common (1% to 10%): Nasopharyngitis
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.
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
Dipeptidyl peptidase-4 inhibitors:
Postmarketing reports: Bullous pemphigoid
Very rare (less than 0.01%): Megaloblastic anemia
Very rare (less than 0.01%): Hepatitis, liver function test abnormalities
Frequency not reported: Myalgia, arthralgia
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).
Common (1% to 10%): Taste disturbance
Common (1% to 10%): Urinary tract infection,
Common (1% to 10%): Headache
Common (1% to 10%): Headache
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Jentadueto Xr