Glaritus Adverse Reactions

The following adverse reactions are discussed elsewhere: Hypoglycemia [see PRECAUTIONS]; Hypersensitivity and allergic reactions [see PRECAUTIONS]; Hypokalemia [see PRECAUTIONS].
Peripheral Edema: Some patients taking insulin glargine have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Lipodystrophy: Administration of insulin subcutaneously, including Insulin Glargine (GLARITUS), has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.
Insulin Initiation and Intensification of Glucose Control: Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Weight Gain: Weight gain has occurred with some insulin therapies including Insulin Glargine (GLARITUS) and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Allergic Reactions: Local Allergy: As with any insulin therapy, patients taking Insulin Glargine (GLARITUS) may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation.
Systemic Allergy: Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including insulin glargine and may be life threatening.
Immunogenicity: As with all therapeutic proteins, there is potential for immunogenicity. All insulin products can elicit the formation of insulin antibodies. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose.
Medication errors have been reported in which other insulins, particularly rapid-acting insulins, have been accidentally administered instead of insulin glargine. To avoid medication errors between Insulin Glargine (GLARITUS) and other insulins, patients should be instructed to always verify the insulin label before each injection.
Other adverse event reported in patients administered with Insulin Glargine (GLARITUS) include upper respiratory tract infection, peripheral edema, hypertension, influenza, sinusitis, cataract, bronchitis, arthralgia, pain in extremity, back pain, cough, urinary tract infection, diarrhea, depression, headache, accidental injury, infection and retinal vascular disorder.