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Novolog

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NovoLog

NovoLog

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 NovoLog (insulin aspart [rdna origin] inj) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

  • The following are examples of substances that may increase the blood-glucoselowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.
  • The following are examples of substances that may reduce the blood-glucoselowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics.
  • Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
  • Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
  • The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine.

Read the NovoLog Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.

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NovoLog - User Reviews

NovoLog User Reviews

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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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