Lantus Side Effects

Please note - some side effects for Lantus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Lantus - for the consumer

Lantus Cartridge Systems

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lantus Cartridge Systems:

Redness, swelling, itching, or mild pain at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

Lantus Solostar Cartridge Systems

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lantus Solostar Cartridge Systems:

Redness, swelling, itching, or mild pain at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

Lantus Solostar Pens

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lantus Solostar Pens:

Redness, swelling, itching, or mild pain at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

Lantus Vials

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lantus Vials:

Redness, swelling, itching, or mild pain at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.

For the professional

Lantus

The adverse events commonly associated with Lantus include the following:

Body as a whole: allergic reactions.

Skin and appendages: injection site reaction, lipodystrophy, pruritus, rash.

Other: hypoglycemia.

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.

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