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Insulin aspart / insulin degludec Side Effects

Applies to insulin aspart/insulin degludec: subcutaneous solution

General

The most frequently reported adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.[Ref]

Metabolic

Weight gain, attributed to the anabolic effects of insulin, has been reported. In clinical trials, an average weight gain of 1.6 kg and 2.8 kg was reported in patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]

Very common (10% or more): Hypoglycemia (up to 95%)

Frequency not reported: Weight gain[Ref]

Immunologic

Common (1% to 10%): Influenza

Frequency not reported: Anti-insulin antibodies[Ref]

The detection of antibodies is dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies may be misleading. In a study in insulin-experienced patients with type 1 diabetes receiving insulin degludec/insulin aspart, 13% were positive for anti-insulin aspart antibodies at least once during the study, including 6.4% who were positive at baseline. For insulin degludec, in adult insulin experienced type 1 diabetes patients, 63.5% of patients receiving this insulin were positive at baseline for anti-insulin degludec antibodies and 15.4% developed anti-insulin degludec antibodies at least once during the study. In immunogenic trials, 99.4% to 100% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.[Ref]

Cardiovascular

In clinical trials, peripheral edema was reported in 2.2% and 1.8% of patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]

Common (1% to 10%): Peripheral edema[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching; urticaria[Ref]

Local

Common (1% to 10%): Injection site reactions including hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass

Uncommon (0.1% to 1%): Lipodystrophy[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 24.6%)

Common (1% to 10%): Upper respiratory tract infection[Ref]

Nervous system

Common (1% to 10%): Headache

References

1. "Product Information. Ryzodeg 70/30 FlexTouch (insulin aspart-insulin degludec)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.

Medically reviewed by Drugs.com. Last updated on July 9, 2020.

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Ryzodeg 70/30

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Some side effects may not be reported. You may report them to the FDA.