Recommended Topic Related To:

Novolog

"As the number of people diagnosed with diabetes continues to grow, illegally sold products promising to prevent, treat, and even cure diabetes are flooding the marketplace.

The Food and Drug Administration (FDA) is advising consumers no"...

NovoLog

NovoLog

Novolog Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

NovoLog (insulin aspart [rDNA origin] injection) is used to treat type 1 (insulin-dependent) diabetes in adults and children who are at least 2 years old. It is usually given together with another long-acting insulin. Insulin is a hormone that is produced in the body. Common side effects include injection site reactions (e.g., pain, redness, irritation).

The dosage of NovoLog is individualized. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day. NovoLog may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. There are many other medicines that can increase or decrease the effects of insulin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Tell your doctor if you are pregnant before using NovoLog. Tell your doctor if you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. This medication does not pass into breast milk. Your insulin needs may change while breast-feeding. Consult your doctor before breast-feeding.

Our NovoLog (insulin aspart [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.

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.

Novolog 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.

Call your doctor if you have a serious side effect such as:

  • swelling in your hands or feet; or
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Hypoglycemia, or low blood sugar, is the most common side effect of insulin aspart. 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.

Insulin aspart can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

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 Novolog (Insulin Aspart [rDNA origin] Inj) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Novolog Overview - Patient Information: Side Effects

SIDE EFFECTS: Injection site reactions (such as pain, redness, irritation) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 or if you took too much insulin. 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, fast heartbeat, sweating, 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 Novolog (Insulin Aspart [rDNA origin] Inj)»

What is Prescribing information?

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

Novolog FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

  • Hypoglycemia
    Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NovoLog [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. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
  • Lipodystrophy
    Long-term use of insulin, including NovoLog, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy.
  • Weight gain
    Weight gain can occur with some insulin therapies, including NovoLog, 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.
  • Frequencies of adverse drug reactions
    The frequencies of adverse drug reactions during NovoLog clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus (Adverse events with frequency ≥ 5% and occurring more frequently with NovoLog compared to human regular insulin are listed)

Preferred Term NovoLog + NPH
N= 596
Human Regular Insulin + NPH
N= 286
N (%) N (%)
Hypoglycemia* 448 75% 205 72%
Headache 70 12% 28 10%
Injury accidental 65 11% 29 10%
Nausea 43 7% 13 5%
Diarrhea 28 5% 9 3%
*Hypoglycemia is defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms. See Clinical Studies for the incidence of serious hypoglycemia in the individual clinical trials.

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (except for hypoglycemia, adverse events with frequency ≥ 5% and occurring more frequently with NovoLog compared to human regular insulin are listed)

  NovoLog + NPH
N= 91
Human Regular Insulin + NPH
N= 91
N (%) N (%)
Hypoglycemia* 25 27% 33 36%
Hyporeflexia 10 11% 6 7%
Onychomycosis 9 10% 5 5%
Sensory disturbance 8 9% 6 7%
Urinary tract infection 7 8% 6 7%
Chest pain 5 5% 3 3%
Headache 5 5% 3 3%
Skin disorder 5 5% 2 2%
Abdominal pain 5 5% 1 1%
Sinusitis 5 5% 1 1%
*Hypoglycemia is defined as an episode of blood glucose concentration < 45 mg/dL, with or without symptoms. See Clinical Studies for the incidence of serious hypoglycemia in the individual clinical trials.

Postmarketing Data

The following additional adverse reactions have been identified during postapproval use of NovoLog. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. Medication errors in which other insulins have been accidentally substituted for NovoLog have been identified during postapproval use [see PATIENT INFORMATION].

Read the entire FDA prescribing information for Novolog (Insulin Aspart [rDNA origin] Inj) »

A A A

NovoLog - User Reviews

NovoLog User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication NovoLog sorted by most helpful. Patient Discussions FAQs

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.


Diabetes

Find tips and advances in treatment.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations