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Novolog

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NovoLog

Side Effects
Interactions

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 post-approval 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 post-approval 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

Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with NovoLog use may be increased with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when NovoLog is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of NovoLog

The glucose lowering effect of NovoLog may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when NovoLog is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of NovoLog

The glucose lowering effect of NovoLog may be increased or decreased when co-administered with alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when NovoLog is co-administered with these drugs.

Drugs That May Affect Hypoglycemia Signs And Symptoms

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with NovoLog.

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

Last reviewed on RxList: 1/28/2015
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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NovoLog - User Reviews

NovoLog User Reviews

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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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