"The US Food and Drug Administration (FDA) gave final approval yesterday to a copycat version of insulin glargine injection (Basaglar, Eli Lilly and Company) for diabetes that is called a follow-on product by the agency and is a biosimilar "...
Humulin N Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Humulin N (insulin human recombinant) [Human insulin (rDNA origin) isophane suspension] is a man-made insulin product indicated for glucose control in patients with diabetes. Hypoglycemia (low blood sugar) is a frequent side effect of Humulin N (insulin). Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Other side effects of Humulin N include injection site reactions (pain, redness, irritation). Tell your doctor if you have serious side effects of Humulin including signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).
Humulin N (insulin human recombinant) is administered by injection. Any change of insulin should be made cautiously and only under medical supervision. Changes in strength, manufacturer, type (e.g, regular, NPH, analog), species, or method of manufacture may result in the need to change dosage. Humulin N may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Tell your doctor all medications and supplements you use. Humulin N (insulin human recombinant) should be used during pregnancy only if clearly needed. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if Humulin N passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Humulin N 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.
Humulin N 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 isophane. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic 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 isophane.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Humulin N (Insulin (Human Recombinant))
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Humulin N Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).
This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Humulin N (Insulin (Human Recombinant))
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Humulin N FDA Prescribing Information: Side Effects
The following adverse reactions are discussed elsewhere in the labeling:
The following additional adverse reactions have been identified during post-approval use of HUMULIN N. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Some patients taking HUMULIN N have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see WARNINGS AND PRECAUTIONS].
Some patients taking HUMULIN N have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Administration of insulin subcutaneously, including HUMULIN N, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see DOSAGE AND ADMINISTRATION] in some patients.
Weight gain has occurred with some insulin therapies including HUMULIN N and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Development of antibodies that react with human insulin have been observed with all insulin, including HUMULIN N.
Read the entire FDA prescribing information for Humulin N (Insulin (Human Recombinant))
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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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