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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.

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.

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.

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

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


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[Ref]


Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Angioedema[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]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Erectile dysfunction (with metformin)[Ref]


Common (1% to 10%): Blood creatine phosphokinase increased, anemia, decreased in absolute lymphocyte count (dose related)[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 (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]


Common (1% to 10%): Fatigue[Ref]


Common (1% to 10%): Anxiety, depression[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
Postmarketing reports: Anaphylaxis, angioedema, rash, urticaria[Ref]


1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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:" ([2015, Aug 28]):

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