Lantus Side Effects Center

Last updated on RxList: 6/15/2022
Lantus Side Effects Center

What Is Lantus?

Lantus (insulin glargine [rdna origin]) Injection is a man-made form of a hormone that is produced in the body used to treat type 1 (insulin-dependent) or type 2 (non insulin-dependent) diabetes.

What Are Side Effects of Lantus?

The most common side effects of Lantus is hypoglycemia, or low blood sugar. Symptoms include:

Other common side effects of Lantus include pain, redness, swelling, itching, or thickening of the skin at the injection site. These side effects usually go away after a few days or weeks.

Dosage for Lantus

Lantus should be administered subcutaneously (under the skin) once a day at the same time every day. Dose is determined by the individual and the desired blood glucose levels.

What Drugs, Substances, or Supplements Interact with Lantus?

Lantus may interact with albuterol, clonidine, reserpine, or beta-blockers. Many other medicines can increase or decrease the effects of insulin glargine on lowering your blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Lantus During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant before using Lantus. Discuss a plan to manage blood sugar with your doctor before becoming pregnant. Your doctor may switch the type of insulin you use during pregnancy. It is unknown if this drug passes into breast milk. Insulin needs may change while breastfeeding. Consult your doctor before breast-feeding.

Additional Information

Our Lantus (insulin glargine [rdna origin]) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Diabetes is defined best as... See Answer
Lantus Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • rapid weight gain, swelling in your feet or ankles;
  • shortness of breath; or
  • low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;
  • swelling, weight gain;
  • allergic reaction, itching, rash; or
  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lantus (Insulin Glargine [rDNA origin] Injection)

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Lantus Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia [see WARNINGS AND PRECAUTIONS]
  • Hypoglycemia Due to Medication Errors [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

The data in Table 1 reflect the exposure of 2,327 patients with type 1 diabetes to LANTUS or NPH in Studies A, B, C, and D [see Clinical Studies]. The type 1 diabetes population had the following characteristics: Mean age was 39 years. Fifty-four percent were male, 97% were Caucasian, 22% were Black or African American and 33% were Hispanic. The mean BMI was 25.1 kg/m2.

The data in Table 2 reflect the exposure of 1,563 patients with type 2 diabetes to LANTUS or NPH in Studies E, F, and G [see Clinical Studies]. The type 2 diabetes population had the following characteristics: Mean age was 59 years. Fifty-eight percent were male, 87% were Caucasian, 8% were Black or African American and 9% were Hispanic. The mean BMI was 29.2 kg/m2.

The frequencies of adverse reactions during LANTUS clinical studies in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below (Tables 1, 2, 3, and 4).

Table 1: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 28 Weeks Duration in Adults with Type 1 Diabetes

LANTUS, %
(n=1,257)
NPH, %
(n=1,070)
Upper respiratory tract infection 22.4 23.1
Infection* 9.4 10.3
Accidental injury 5.7 6.4
Headache 5.5 4.7
* Body system not specified

Table 2: Adverse Reactions Occurring ≥5% in Pooled Clinical Studies up to 1 Year Duration in Adults with Type 2 Diabetes

LANTUS, %
(n=849)
NPH, %
(n=714)
Upper respiratory tract infection 11.4 13.3
Infection* 10.4 11.6
Retinal vascular disorder 5.8 7.4
* Body system not specified

Table 3: Adverse Reactions Occurring ≥10% in a 5-Year Study of Adults with Type 2 Diabetes

LANTUS, %
(n=514)
NPH, %
(n=503)
Upper respiratory tract infection 29.0 33.6
Edema peripheral 20.0 22.7
Hypertension 19.6 18.9
Influenza 18.7 19.5
Sinusitis 18.5 17.9
Cataract 18.1 15.9
Bronchitis 15.2 14.1
Arthralgia 14.2 16.1
Pain in extremity 13.0 13.1
Back pain 12.8 12.3
Cough 12.1 7.4
Urinary tract infection 10.7 10.1
Diarrhea 10.7 10.3
Depression 10.5 9.7
Headache 10.3 9.3

Table 4: Adverse Reactions Occurring ≥5% in a 28-Week Clinical Study in Pediatric Patients with Type 1 Diabetes

LANTUS, %
(n=174)
NPH, %
(n=175)
Infection* 13.8 17.7
Upper respiratory tract infection 13.8 16.0
Pharyngitis 7.5 8.6
Rhinitis 5.2 5.1
* Body system not specified

Severe Hypoglycemia

Hypoglycemia was the most commonly observed adverse reaction in patients treated with LANTUS. Tables 5, 6, and 7 summarize the incidence of severe hypoglycemia in the LANTUS clinical studies. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤56 mg/dL in the 5-year study and ≤36 mg/dL in the ORIGIN study) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

Percentages of LANTUS-treated adult patients who experienced severe symptomatic hypoglycemia in the LANTUS clinical studies [see Clinical Studies] were comparable to percentages of NPH-treated patients for all treatment regimens (see Tables 5 and 6). In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult studies with type 1 diabetes.

Table 5: Severe Symptomatic Hypoglycemia in Patients with Type 1 Diabetes

Study A
Type 1 Diabetes
Adults
28 weeks
In combination with regular insulin
Study B
Type 1 Diabetes
Adults
28 weeks
In combination with regular insulin
Study C
Type 1 Diabetes
Adults
16 weeks
In combination with insulin lispro
Study D
Type 1 Diabetes
Pediatrics
26 weeks
In combination with regular insulin
LANTUS
N=292
NPH
N=293
LANTUS
N=264
NPH
N=270
LANTUS
N=310
NPH
N=309
LANTUS
N=174
NPH
N=175
Percent of patients 10.6 15.0 8.7 10.4 6.5 5.2 23.0 28.6

Table 6: Severe Symptomatic Hypoglycemia in Patients with Type 2 Diabetes

Study E
Type 2 Diabetes
Adults
52 weeks
In combination with oral agents
Study F
Type 2 Diabetes
Adults
28 weeks
In combination with regular insulin
Study G
Type 2 Diabetes
Adults
5 years
In combination with regular insulin
LANTUS
N=289
NPH
N=281
LANTUS
N=259
NPH
N=259
LANTUS
N=513
NPH
N=504
Percent of patients 1.7 1.1 0.4 2.3 7.8 11.9

Table 7 displays the proportion of patients who experienced severe symptomatic hypoglycemia in the LANTUS and Standard Care groups in the ORIGIN study [see Clinical Studies].

Table 7: Severe Symptomatic Hypoglycemia in the ORIGIN Study

ORIGIN Study
Median duration of follow-up: 6.2 years
LANTUS
N=6231
Standard Care
N=6273
Percent of patients 5.6 1.8
Peripheral Edema

Some patients taking LANTUS have experienced sodium retention and edema, particularly if previously poor metabolic control was improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including LANTUS, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see DOSAGE AND ADMINISTRATION].

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 insulin including LANTUS and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Hypersensitivity Reactions

Local Reactions

Patients taking LANTUS experienced injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of injection site pain in LANTUS-treated patients (2.7%) compared to NPH insulintreated patients (0.7%). The reports of pain at the injection site did not result in discontinuation of therapy.

Systemic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including LANTUS 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. In clinical studies of LANTUS, increases in titers of antibodies to insulin were observed in NPH insulin and LANTUS treatment groups with similar incidences.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LANTUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which rapid-acting insulins and other insulins, have been accidentally administered instead of LANTUS

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

DRUG INTERACTIONS

Table 8 includes clinically significant drug interactions with LANTUS.

Table 8: Clinically Significant Drug Interactions with LANTUS

Drugs that May Increase the Risk of Hypoglycemia
Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics. GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors.
Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Drugs that May Decrease the Blood Glucose Lowering Effect of LANTUS
Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Intervention: Dosage increases and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of LANTUS
Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dosage adjustment and increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.
Drugs that May Blunt Signs and Symptoms of Hypoglycemia
Drugs: Beta-blockers, clonidine, guanethidine, and reserpine.
Intervention: Increased frequency of glucose monitoring may be required when LANTUS is coadministered with these drugs.

Read the entire FDA prescribing information for Lantus (Insulin Glargine [rDNA origin] Injection)

© Lantus Patient Information is supplied by Cerner Multum, Inc. and Lantus Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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