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The following adverse reactions are discussed elsewhere:
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 with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
Table 1: Treatment-Emergent Adverse Events in Patients
with Type 1 Diabetes Mellitus (adverse events with frequency ≥ 5%)
|Events, n (%)||Lispro
|Regular human insulin
|Flu syndrome||28 (34.6)||28 (32.6)||56 (33.5)|
|Pharyngitis||27 (33.3)||29 (33.7)||56 (33.5)|
|Rhinitis||20 (24.7)||25 (29.1)||45 (26.9)|
|Headache||24 (29.6)||19 (22.1)||43 (25.7)|
|Pain||16 (19.8)||14 (16.3)||30 (18.0)|
|Cough increased||14 (17.3)||15 (17.4)||29 (17.4)|
|Infection||11 (13.6)||18 (20.9)||29 (17.4)|
|Nausea||5 (6.2)||13 (15.1)||18 (10.8)|
|Accidental injury||7 (8.6)||10 (11.6)||17 (10.2)|
|Surgical procedure||5 (6.2)||12 (14.0)||17 (10.2)|
|Fever||5 (6.2)||10 (11.6)||15 (9.0)|
|Abdominal pain||6 (7.4)||7 (8.1)||13 (7.8)|
|Asthenia||6 (7.4)||7 (8.1)||13 (7.8)|
|Bronchitis||6 (7.4)||6 (7.0)||12 (7.2)|
|Diarrhea||7 (8.6)||5 (5.8)||12 (7.2)|
|Dysmenorrhea||5 (6.2)||6 (7.0)||11 (6.6)|
|Myalgia||6 (7.4)||5 (5.8)||11 (6.6)|
|Urinary tract infection||5 (6.2)||4 (4.7)||9 (5.4)|
Table 2: Treatment-Emergent
Adverse Events in Patients with Type 2 Diabetes Mellitus (adverse events with
frequency ≥ 5%)
|Events, n (%)||Lispro
|Regular human insulin
|Headache||63 (11.6)||66 (9.3)||149 (10.5)|
|Pain||77 (10.8)||71 (10.0)||148 (10.4)|
|Infection||72 (10.1)||54 (7.6)||126 (8.9)|
|Pharyngitis||47 (6.6)||58 (8.2)||105 (7.4)|
|Rhinitis||58 (8.1)||47 (6.6)||105 (7.4)|
|Flu syndrome||44 (6.2)||58 (8.2)||102 (7.2)|
|Surgical procedure||53 (7.4)||48 (6.8)||101 (7.1)|
Insulin initiation and intensification of glucose control
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.
Long-term use of insulin, including HUMALOG, 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 [see DOSAGE AND ADMINISTRATION].
Weight gain can occur with insulin therapy, including HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Insulin, including HUMALOG, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII)
In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for HUMALOG and regular human insulin treated patients (see Table 3).
Table 3: Catheter Occlusions and Infusion Site
|Regular human insulin
|Infusion site reactions||2.6% (1/38)||2.6% (1/39)|
In a randomized, 16-week, open-label, parallel design study of children and adolescents with type 1 diabetes, adverse event reports related to infusion-site reactions were similar for insulin lispro and insulin aspart (21% of 100 patients versus 17% of 198 patients, respectively). In both groups, the most frequently reported infusion site adverse events were infusion site erythema and infusion site reaction.
Local Allergy — As with any insulin therapy, patients taking HUMALOG may experience redness, swelling, or itching at the site of the injection. These minor reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of HUMALOG. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique.
Systemic Allergy — Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin, including HUMALOG. Generalized allergy to insulin may cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.
In controlled clinical trials, pruritus (with or without rash) was seen in 17 patients receiving regular human insulin (n=2969) and 30 patients receiving HUMALOG (n=2944).
Localized reactions and generalized myalgias have been reported with injected metacresol, which is an excipient in HUMALOG [see CONTRAINDICATIONS].
In large clinical trials with patients with type 1 (n=509) and type 2 (n=262) diabetes mellitus, anti-insulin antibody (insulin lispro-specific antibodies, insulin-specific antibodies, cross-reactive antibodies) formation was evaluated in patients receiving both regular human insulin and HUMALOG (including patients previously treated with human insulin and naive patients). As expected, the largest increase in the antibody levels occurred in patients new to insulin therapy. The antibody levels peaked by 12 months and declined over the remaining years of the study. These antibodies do not appear to cause deterioration in glycemic control or necessitate an increase in insulin dose. There was no statistically significant relationship between the change in the total daily insulin dose and the change in percent antibody binding for any of the antibody types.
The following additional adverse reactions have been identified during post-approval use of HUMALOG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Medication errors in which other insulins have been accidentally substituted for HUMALOG have been identified during postapproval use [see PATIENT INFORMATION].
Read the Humalog (insulin lispro (human analog)) Side Effects Center for a complete guide to possible side effects
A number of drugs affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring. Following are some of the examples:
- Drugs That May Increase the Blood-Glucose-Lowering Effect of HUMALOG and Susceptibility to Hypoglycemia: Oral antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide).
- Drugs That May Reduce the Blood-Glucose-Lowering Effect of HUMALOG: corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones.
- Drugs That May Increase or Reduce the Blood-Glucose-Lowering Effect of HUMALOG: beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
- Drugs That May Reduce the Signs of Hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.
Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.
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