Onglyza Side Effects
Generic name: saxagliptin
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
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.
For the Consumer
Applies to saxagliptin: oral tablets
Side effects include:
Saxagliptin in combination with immediate-release metformin: Headache, nasopharyngitis.
For Healthcare Professionals
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.[Ref]
Very common (10% or more): Hypoglycemia
Uncommon (0.1% to 1%): Dyslipidemia, hypertriglyceridemia[Ref]
Common (1% to 10%): Hypertension, peripheral edema
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]
Common (1% to 10%): Rash
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]
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Abdominal pain
Postmarketing reports: Acute pancreatitis[Ref]
Common (1% to 10%): Urinary tract infection
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]
Common (1% to 10%): Fatigue[Ref]
Common (1% to 10%): Upper respiratory tract infection, sinusitis, nasopharyngitis, bronchitis[Ref]
Uncommon (0.1% to 1%): Hypersensitivity reactions
Rare (less than 0.1%): Anaphylactic reactions including anaphylactic shock
Frequently asked questions
More about Onglyza (saxagliptin)
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- Drug class: dipeptidyl peptidase 4 inhibitors
- FDA approval history
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Onglyza (saxagliptin)." Bristol-Myers Squibb (2009):
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. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." (2015):
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.