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Note: This document contains side effect information about empagliflozin / linagliptin. Some of the dosage forms listed on this page may not apply to the brand name Glyxambi.
Common side effects of Glyxambi include: urinary tract infection. Other side effects include: increased ldl cholesterol. See below for a comprehensive list of adverse effects.
Applies to empagliflozin / linagliptin: oral tablet, tablet oral
Along with its needed effects, empagliflozin/linagliptin 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 empagliflozin / linagliptin:
Incidence not known
Some side effects of empagliflozin / 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:
Incidence not known
Applies to empagliflozin / linagliptin: oral tablet
The most commonly occurring adverse events have included urinary tract infections, nasopharyngitis, and upper respiratory tract infections.
Common (1% to 10%): Nausea
Common (1% to 10%): Diarrhea
Frequency not reported: Pancreatitis
Postmarketing reports: Acute pancreatitis, mouth ulceration
Pancreatitis was reported in 15.2 cases per 10,000 patient year exposure in patients receiving linagliptin compared to 3.7 cases per 10,000 patient year exposure in those receiving active comparator (placebo or sulfonylurea), during clinical trials. Following completing of clinical trials, 3 additional cases of pancreatitis were reported in those receiving linagliptin. Postmarketing reports of acute pancreatitis, including fatalities, have been reported.
Common (1% to 10%): Pruritus
Postmarketing reports: Rash
Postmarketing reports: Rash, bullous pemphigoid
Postmarketing reports of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitors. Discontinuation of therapy and treatment with topical or systemic immunosuppressive agents led to resolution in reported cases.
When this combination product was added to metformin therapy, the overall incidence of hypoglycemia was 2.2% and 3.6% in patients receiving empagliflozin 10 mg-linagliptin 5 mg and empagliflozin 25 mg-linagliptin 5 mg, respectively. There were no reports of serious hypoglycemia.
Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.
Common (1% to 10%): Hypoglycemia, increased cholesterol, thirst
Common (1% to 10%): Increased low-density lipoprotein cholesterol, dyslipidemia
Rare (Less than 0.1%): Ketoacidosis
Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis
Common (1% to 10%): Increased uric acid
In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in men and women (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months). All SGLT2 inhibitor drugs except ertugliflozin were included in the reports. Ertugliflozin being the most recently approved agent, is expected to have the same risk, but insufficient patient use to assess risk. All patients were hospitalized, all required surgery, all required surgical debridement, 5 required more than 1 surgery and 1 required skin grafting. Four cases were complicated by diabetic ketoacidosis, acute kidney injury, and septic shock, leading to prolonged hospitalization, and death in 1 case. In the general population, Fournier's gangrene occurs in about 1.6 out of 100,000 males annually, with the highest incidence in men 50 to 79 years. Since diabetes is a risk factor for Fournier's gangrene, a review of the FAERS database for the last 34 years was done and only 6 cases (all males, median age 57 years) were found with several other classes of antidiabetic drugs. Findings with SGLT2 inhibitors appear to show an association over a shorter time frame and involve both males and females.
Very Common (10% or more): Urinary tract infection (up to 12.5%)
Postmarketing reports: Urosepsis, pyelonephritis
Common (1% to 10%): Urinary tract infection, female genital mycotic infections, vaginal moniliasis, vulvovaginitis, balanitis, increased urination, male genital mycotic infections
Uncommon (0.1% to 1%): Dysuria
Postmarketing reports: Fournier's gangrene
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Hypersensitivity reactions including urticaria, angioedema, localized skin exfoliation, or bronchial hyper-reactivity
Postmarketing reports: Serious hypersensitivity reactions including anaphylaxis, angioedema
Postmarketing, serious hypersensitivity reactions including angioedema, anaphylaxis, and exfoliative skin conditions have been reported in patients treated with linagliptin. These reactions have occurred within the first 3 months and some have occurred after the first dose.
Frequency not reported: Increased serum creatinine, decreased eGFR
Postmarketing reports: Acute kidney injury (AKI)
Postmarketing reports of AKI, some requiring hospitalization and dialysis, have been received for patients treated with SGLT2 inhibitors including empagliflozin. Some reports involved patients younger than 65 years old.
Common (1% to 10%): Nasopharyngitis, upper respiratory infection
Common (1% to 10%): Upper respiratory infection
Common (1% to 10%): Nasopharyngitis, cough
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).
Dipeptidyl peptidase-4 (DPP-4) inhibitors:
-Common (1% to 10%): Arthralgia
-Postmarketing cases: Severe and disabling arthralgia
Uncommon (0.1% to 1%): Volume depletion
Frequency not reported: Increased hematocrit
Common (1% to 10%): Increased hematocrit