Lantus (Insulin Glargine) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The adverse events commonly associated with LANTUS include the following:

Body as a whole: allergic reactions (see PRECAUTIONS).

Skin and appendages: injection site reaction, lipodystrophy, pruritus, rash (see PRECAUTIONS).

Other: hypoglycemia (see WARNINGS and PRECAUTIONS).

In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy. Other treatment-emergent injection site reactions occurred at similar incidences with both insulin glargine and NPH human insulin.

Retinopathy was evaluated in the clinical studies by means of retinal adverse events reported and fundus photography. The numbers of retinal adverse events reported for LANTUS and NPH treatment groups were similar for patients with type 1 and type 2 diabetes. Progression of retinopathy was investigated by fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Study (ETDRS). In one clinical study involving patients with type 2 diabetes, a difference in the number of subjects with ≥3-step progression in ETDRS scale over a 6-month period was noted by fundus photography (7.5% in LANTUS group versus 2.7% in NPH treated group). The overall relevance of this isolated finding cannot be determined due to the small number of patients involved, the short follow-up period, and the fact that this finding was not observed in other clinical studies.

REPORTS OF SUSPECTED LANTUS SIDE EFFECTS / ADVERSE REACTIONS

Possible Lantus side effects / adverse reactions in 80 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 80 year old male

Reactions: Product Quality Issue, Laceration, Fall, Renal Impairment, Syncope, Cardiac Pacemaker Insertion, Cardiac Failure Congestive, Blood Glucose Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Opticlick
    Indication: Type 2 Diabetes Mellitus

Solostar
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-01-01

Lantus
    Dosage: dose:30 unit(s)
    Indication: Type 2 Diabetes Mellitus

Lantus
    Dosage: dose:30 unit(s)
    Start date: 2011-05-30
    End date: 2011-07-31

Lantus
    Dosage: dose:30 unit(s)
    Start date: 2011-01-01

Other drugs received by patient: Oral Antidiabetics

Possible Lantus side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 67 year old female

Reactions: Bronchitis, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus
    Dosage: dose:20 unit(s)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2007-01-01

Solostar
    Indication: Type 2 Diabetes Mellitus
    Start date: 2007-01-01

Other drugs received by patient: Novolog; Corticosteroid NOS

Possible Lantus side effects / adverse reactions in 71 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 71 year old female

Reactions: Foot Fracture, Limb Discomfort

Adverse event resulted in: hospitalization

Suspect drug(s):
Lantus
    Dosage: 60-75 units
    Indication: Type 2 Diabetes Mellitus
    Start date: 2001-01-01

Opticlick
    Indication: Type 2 Diabetes Mellitus
    Start date: 2001-01-01

Other drugs received by patient: ALL Other Therapeutic Products