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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.

Summary

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 (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]

Frequently asked questions

References

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):

Further information

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.