Note: This document contains side effect information about saxagliptin. Some of the dosage forms listed on this page may not apply to the brand name Onglyza.
Common side effects of Onglyza include: hypoglycemia. See below for a comprehensive list of adverse effects.
Applies to saxagliptin: oral tablet
Along with its needed effects, saxagliptin (the active ingredient contained in Onglyza) 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 saxagliptin:
Incidence not known
Some side effects of saxagliptin 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:
Applies to saxagliptin: oral tablet
Commonly reported adverse reactions include respiratory tract infection, urinary tract infection, and headache. Peripheral edema was more commonly reported in patients treated with the combination saxagliptin (the active ingredient contained in Onglyza) and thiazolidinedione.
Very common (10% or more): Hypoglycemia
Uncommon (0.1% to 1%): Dyslipidemia, hypertriglyceridemia
Common (1% to 10%): Hypertension, peripheral edema
Frequency not reported: Heart failure
Hospitalization for heart failure occurred more frequently in patients receiving this drug compared with placebo in a cardiovascular outcomes trial that enrolled patients with established, or multiple risk factors for atherosclerotic cardiovascular disease (3.5% vs 2.8%). Additionally, in the time to first event analysis, the risk of hospitalization was higher compared to placebo (Hazard Ratio 1.27; 95% confidence interval 1.07 to 1.51).
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Angioedema
In a cardiovascular outcomes trial that enrolled patients with established, or multiple risk factors for atherosclerotic cardiovascular disease, acute pancreatitis was confirmed in 0.2% (17 of 8240) patients receiving this drug compared with 0.1% (9 of 8173) of the placebo-treated patients. Preexisting risk factor were identified in 88% and 100% of the drug treated patients and placebo patients, respectively.
Common (1% to 10%): Gastroenteritis, vomiting, nausea, dyspepsia, gastritis, flatulence
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Abdominal pain
Postmarketing reports: Acute pancreatitis
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Erectile dysfunction (with metformin)
Common (1% to 10%): Blood creatine phosphokinase increased, anemia, decreased in absolute lymphocyte count (dose related)
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 (the active ingredient contained in Onglyza) (n=5), linagliptin (n=2), alogliptin (n=1), and vildagliptin (n=2).
Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): Arthralgia
Common (1% to 10%): Headache, dizziness
Common (1% to 10%): Fatigue
Common (1% to 10%): Anxiety, depression
Common (1% to 10%): Upper respiratory tract infection, sinusitis, nasopharyngitis, bronchitis
Uncommon (0.1% to 1%): Hypersensitivity reactions
Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock
Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Onglyza