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Novolog (Insulin Aspart Injection) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (5) ].

  • 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)

NovoLog + NPH

N= 596

Human Regular Insulin + NPH

N= 286

Preferred Term

N

(%)

N

(%)

Hypoglycemia 1

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%

1 Hypoglycemia is defined as an episode of blood glucose concentration <45 mg/dL, with or without symptoms. See Section 14 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 1

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%

1 Hypoglycemia is defined as an episode of blood glucose concentration <45 mg/dL, with or without symptoms. See Section 14 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 Counseling Information ].



REPORTS OF SUSPECTED NOVOLOG SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Novolog. The information is not vetted and should not be considered as verified clinical evidence.

Possible Novolog side effects / adverse reactions in 46 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 46 year old female weighing 90.3 kg (198.6 pounds)

Reactions: Blood Glucose Increased

Suspect drug(s):
Novolog



Possible Novolog side effects / adverse reactions in 64 year old female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: 64 year old female

Reactions: Neoplasm Malignant

Suspect drug(s):
Novolog



Possible Novolog side effects / adverse reactions in 39 year old female

Reported by a consumer/non-health professional from United States on 2011-10-10

Patient: 39 year old female weighing 100.7 kg (221.5 pounds)

Reactions: Weight Increased, Dyspnoea, Balance Disorder, Insomnia, Oedema Peripheral

Suspect drug(s):
Novolog
    Dosage: 7 u, tid, before meals
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-29
    End date: 2011-09-19

Levemir
    Dosage: 30 u, qhs
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-08-29
    End date: 2011-09-19

Other drugs received by patient: Multivitamin /00097801/; Vitamin D; Flaxseed OIL; Prenatal Vitamins /01549301/



See index of all Novolog side effect reports >>

Drug label data at the top of this Page last updated: 2014-04-25

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