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Saxagliptin Side Effects

In Summary

Commonly reported side effects of saxagliptin include: hypoglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to saxagliptin: oral tablet

Along with its needed effects, saxagliptin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking saxagliptin:

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
  • 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
  • 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

  • Chest pain
  • constipation
  • darkened urine
  • decreased urine output
  • difficulty with swallowing
  • dilated neck veins
  • extreme fatigue
  • flaking or peeling of the skin
  • hives or skin rash
  • indigestion
  • irregular breathing
  • irregular heartbeat
  • large, hard skin blisters
  • 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
  • severe joint pain
  • swelling of face, fingers, feet, or lower leg
  • tightness in the chest
  • troubled breathing
  • vomiting
  • weight gain
  • yellow eyes or skin

Some side effects of saxagliptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions 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 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 (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]):

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.

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