Note: This document contains side effect information about saxagliptin. Some dosage forms listed on this page may not apply to the brand name Onglyza.
Summary
Common side effects of Onglyza include: hypoglycemia. Continue reading for a comprehensive list of adverse effects.
Applies to saxagliptin: oral tablets.
Side effects include:
Saxagliptin (the active ingredient contained in Onglyza) monotherapy: Upper respiratory infection, urinary tract infection, headache.
Saxagliptin in combination with dapagliflozin and metformin: Upper respiratory tract infection, urinary tract infection, dyslipidemia, headache, diarrhea, back pain, genital infection, arthralgia.
Saxagliptin in combination with immediate-release metformin: Headache, nasopharyngitis.
For Healthcare Professionals
Applies to saxagliptin: oral tablet.
General
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.[Ref]
Metabolic
Very common (10% or more): Hypoglycemia
Uncommon (0.1% to 1%): Dyslipidemia, hypertriglyceridemia[Ref]
Cardiovascular
Common (1% to 10%): Hypertension, peripheral edema
Frequency not reported: Heart failure[Ref]
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).[Ref]
Dermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Angioedema[Ref]
Gastrointestinal
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.[Ref]
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[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Erectile dysfunction (with metformin)[Ref]
Hematologic
Common (1% to 10%): Blood creatine phosphokinase increased, anemia, decreased in absolute lymphocyte count (dose related)[Ref]
Musculoskeletal
Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): 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
Common (1% to 10%): Headache, dizziness[Ref]
Other
Common (1% to 10%): Fatigue[Ref]
Psychiatric
Common (1% to 10%): Anxiety, depression[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection, sinusitis, nasopharyngitis, bronchitis[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reactions
Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock
Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria[Ref]
