"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
Humalog Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Humalog (insulin lispro [rDNA origin]) Injection is a hormone that is produced in the body used to treat type 1 (insulin-dependent) diabetes in adults. It is usually given together with another long-acting insulin. Humalog is also used together with oral medications to treat type 2 (non insulin-dependent) diabetes in adults. Common side effects of Humalog include injection site reactions (e.g., pain, redness, irritation). Hypoglycemia, or low blood sugar, is the most common side effect of insulin lispro. 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).
The total daily insulin requirement varies and the dose is usually between 0.5 to 1 unit/kg/day. Insulin needs may be altered during stress, major illness, or changes in exercise, meal patterns, or co-administered drugs. Humalog may interact with albuterol, clonidine, reserpine, guanethidine, or beta-blockers. Many other medicines can increase or decrease the effects of insulin lispro on lowering blood sugar. Tell your doctor all prescription and over-the-counter medications and supplements you use. Tell your doctor if you are pregnant before using Humalog. Discuss a plan for managing blood sugars with your doctor before becoming pregnant. Your doctor may switch the type of insulin used during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Humalog (insulin lispro, USP [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.
Humalog 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.
Hypoglycemia, or low blood sugar, is the most common side effect of insulin lispro. 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 lispro 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.
Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin lispro.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Humalog (Insulin Lispro (Human Analog))
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Humalog Overview - Patient Information: Side Effects
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. 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, 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 Humalog (Insulin Lispro (Human Analog))
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Humalog FDA Prescribing Information: Side Effects
Observed With HUMALOG U-100
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)|
|Pharyngitis||27 (33.3)||29 (33.7)|
|Rhinitis||20 (24.7)||25 (29.1)|
|Headache||24 (29.6)||19 (22.1)|
|Pain||16 (19.8)||14 (16.3)|
|Cough increased||14 (17.3)||15 (17.4)|
|Infection||11 (13.6)||18 (20.9)|
|Nausea||5 (6.2)||13 (15.1)|
|Accidental injury||7 (8.6)||10 (11.6)|
|Surgical procedure||5 (6.2)||12 (14.0)|
|Fever||5 (6.2)||10 (11.6)|
|Abdominal pain||6 (7.4)||7 (8.1)|
|Asthenia||6 (7.4)||7 (8.1)|
|Bronchitis||6 (7.4)||6 (7.0)|
|Diarrhea||7 (8.6)||5 (5.8)|
|Dysmenorrhea||5 (6.2)||6 (7.0)|
|Myalgia||6 (7.4)||5 (5.8)|
|Urinary tract infection||5 (6.2)||4 (4.7)|
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)|
|Pain||77 (10.8)||71 (10.0)|
|Infection||72 (10.1)||54 (7.6)|
|Pharyngitis||47 (6.6)||58 (8.2)|
|Rhinitis||58 (8.1)||47 (6.6)|
|Flu syndrome||44 (6.2)||58 (8.2)|
|Surgical procedure||53 (7.4)||48 (6.8)|
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) - HUMALOG U-100
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 U-100 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 entire FDA prescribing information for Humalog (Insulin Lispro (Human Analog))
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