Lantus Adverse Reactions

Please tell the physician or pharmacist, if experiencing any adverse effect with the use of this product.
Hypoglycaemia: Hypoglycaemia (see Precautions) may occur if the insulin dose exceeds the requirement. Hypoglycaemia may lead to unconsciousness and, if severe, may cause a heart attack or brain damage and may be life-threatening.
Eyes: A marked change in blood sugar level may cause temporary visual impairment. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycemic episodes may result in transient loss of vision. (See Pharmacology: Pharmacodynamics: Clinical Efficacy: Diabetic Retinopathy under Actions.)
Skin and subcutaneous tissue disorders: Fatty tissue under the skin may shrink or swell (lipoatrophy or lipohypertrophy) at the injection site and delay insulin absorption and its effect. Selecting a different site for each injection may help to reduce or prevent these reactions. Other reactions may occur at the injection site and may also spread into the surrounding area. These include reddening, unusually intense pain on injection, itching, hives, swelling or inflammation. Such reactions usually disappear within a few days or weeks.
Localized cutaneous amyloidosis at the injection site has occurred with insulins. Hyperglycemia has been reported with repeated insulin injections into areas of cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Injection site and allergic reactions: In rare cases, severe allergic reactions to insulins and their excipients may occur. These may include large-scale skin reactions, severe swelling of skin or mucous membranes (Quincke's edema), shortness of breath (bronchospasm), a fall in blood pressure, and circulatory collapse (shock). Severe allergic reactions may under certain circumstances become life-threatening.
Other reactions: Insulin administration may cause insulin antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH and insulin glargine groups. In rare cases, the presence of such insulin antibodies may necessitate dose adjustment.
Rarely, insulin may cause sodium and fluid retention into the tissues (edema), particularly after significant improvement of metabolic control in association with intensified therapy.
Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine.
Pediatric patients: In general, the side effects in patients of 18 years of age or less are similar to those seen in adults. Complaints of injection site reactions and skin reactions are reported relatively more frequently in patients of 18 years of age or less than in adult patients. No clinical study safety data are available in patients below 2 years of age.