May 28, 2016
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Novolin R

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Novolin R




Novolin R Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/27/2015

Novolin R (regular, human insulin [rDNA origin]) is a form of insulin, a naturally occurring hormone, used to control blood sugar in patients with diabetes mellitus. Novolin R is available over-the-counter. The most common side effect of Novolin R is low blood sugar (hypoglycemia). Symptoms of low blood sugar include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure. Other side effects of Novolin R include high blood sugar, and injection site reactions such as redness, swelling, and itching.

The dosing of Novolin R is individualized. It is usually given three or more times daily before meals. Novolin R may interact with oral hypoglycemic agents (OHA), octreotide, monoamine oxidase inhibitors (MAOIs), beta-blockers, ACE inhibitors, salicylates, alcohol, antibiotics, steroids, quinine, quinidine, alpha-blockers, oral contraceptives, thiazides, glucocorticoids, thryroid hormones and sympathomimetics, growth hormone, diazoxide, asparaginase, and nicotinic acid. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Novolin R. Consult your doctor before breastfeeding.

Our Novolin R (regular, human insulin [rDNA origin]) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Novolin R in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin.

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 Novolin R (Recombinant DNA Origin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Novolin R FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

  • Hypoglycemia
    Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R [see WARNINGS AND PRECAUTIONS].
  • Insulin initiation and glucose control intensification
    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. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
  • Lipodystrophy
    Long-term use of insulin, including Novolin R, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.
  • Weight gain
    Weight gain can occur with insulin therapies, including Novolin R, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
  • Peripheral edema
    Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. These symptoms are usually transitory.
  • Allergic reactions
    As with other insulins, Novolin R can cause injection site reactions. Severe, life-threatening, generalized allergy, including anaphylaxis may occur with any insulin, including Novolin R [see WARNINGS AND PRECAUTIONS].

Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Adults With Type 1 Or Type 2 Diabetes

The incidence of adverse reactions during clinical trials comparing Novolin R and insulin aspart in adults with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 286 %
Insulin aspart + NPH
N=596 %
Hypoglycemia* 72 75
* Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms.

Table 2: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 2 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 91 (%)
Insulin aspart + NPH
N= 91 (%)
Hypoglycemia* 36 27
*Hypoglycemia was defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms.

Children And Adolescents With Type 1 Diabetes

The incidence of adverse reactions during a 24-week clinical trial comparing Novolin R and insulin aspart in children and adolescents with type 1 diabetes mellitus are listed in the table below.

Table 3: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Children and Adolescents with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

  Novolin R + NPH
N= 96 (%)
Insulin aspart + NPH
N= 187 (%)
Hypoglycemia* 85 79
Injection site hypertrophy 8 8
*Hypoglycemia was defined as an episode of blood glucose concentration < 50 mg/dL, with or without symptoms.

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R [See WARNINGS AND PRECAUTIONS]. Tables 4 and 5 summarize the incidence of severe hypoglycemia in the Novolin R clinical trials. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring intervention of another person or hospitalization. The rates of severe hypoglycemia in the Novolin R clinical trials (see Clinical Studies for a description of the study designs) were comparable for all treatment regimens (see Tables 4 and 5).

Table 4: Severe Hypoglycemia in Patients with Type 1 Diabetes

  Type 1 Diabetes Adults 24 weeks in combination with NPH insulin Type 1 Diabetes Children and Adolescents (age 6-18) 24 weeks in combination with NPH insulin Type 1 Diabetes Children (age 2-6) 24 weeks in combination with NPH insulin
Novolin R Insulin aspart Novolin R Insulin aspart Novolin R Insulin aspart
Percent of patients (n/total N) 19 (55/286) 18 (105/596) 9 (9/96) 6 (11/187) 12 (3/25) 8 (2/26)
Event/patient/ year 1.1 0.9 0.3 0.2 0.5 0.3

Table 5: Severe Hypoglycemia in Patients with Type 2 Diabetes

  Type 2 Diabetes Adults 24 weeks in combination with NPH insulin
Novolin R Insulin aspart
Percent of patients (n/total N) 5 (5/91) 10 (9/91)
Event/patient/ year 0.2 0.3

Read the entire FDA prescribing information for Novolin R (Recombinant DNA Origin)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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