Novolin R
- Generic Name: recombinant dna origin
- Brand Name: Novolin R
Novolin R(Recombinant DNA Origin) side effects drug center
Novolin R Side Effects Center
What Is Novolin R?
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.
What Are Side Effects of Novolin R?
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,
- weight gain,
- swelling of the extremities, and
- injection site reactions such as redness, swelling, itching, and thickening of the skin.
Dosage for Novolin R
The dosing of Novolin R is individualized. It is usually given three or more times daily before meals.
What Drugs, Substances, or Supplements Interact with Novolin R?
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.
Novolin R During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Novolin R. Consult your doctor before breastfeeding.
Additional Information
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.
Novolin R Consumer Information
Get emergency medical help if you have signs of insulin allergy: redness, swelling, sweating, 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:
- low 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 in your hands or feet;
- weight gain; 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 Novolin R (Recombinant DNA Origin)
Novolin R Professional Information
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)
&Copy; Novolin R Patient Information is supplied by Cerner Multum, Inc. and Novolin R Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.