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Onglyza Side Effects

Generic Name: saxagliptin

Note: This page contains side effects data for the generic drug saxagliptin. It is possible that some of the dosage forms included below may not apply to the brand name Onglyza.

In Summary

Common side effects of Onglyza include: hypoglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to saxagliptin: oral tablet

As well as its needed effects, saxagliptin (the active ingredient contained in Onglyza) may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking saxagliptin, check with your doctor immediately:

More common:
  • Anxiety
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • cough
  • depression
  • difficult, burning, or painful urination
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • increased hunger
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nervousness
  • nightmares
  • rapid weight gain
  • runny nose
  • seizures
  • shakiness
  • slurred speech
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss
Incidence not known:
  • Constipation
  • darkened urine
  • difficulty with swallowing
  • flaking or peeling of the skin
  • hives
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • vomiting
  • wheezing
  • yellow eyes or skin

Severity: Minor

Some saxagliptin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:
  • Diarrhea
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin
  • weakness
  • welts

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

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).[Ref]

Common (1% to 10%): Myalgia, back pain
Uncommon (0.1% to 1%): Arthralgia[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]

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, Princeton, NJ.

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. Available from: URL: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM460038.pdf." ([2015, Aug 28]):

It is possible that some side effects of Onglyza may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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