Humalog ® (insulin lispro)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Humalog Summary of Product Characteristics (SmPC)

Humalog® (insulin lispro): Allergenicity Reporting

The spontaneous reporting rate for hypersensitivity reactions associated with Humalog products is less than 0.01%.

Detailed Information

Local Allergy

Patients may occasionally experience injection site reactions at the site of injection, including

  • redness

  • swelling, and

  • itching.1

This condition usually resolves in a few days to a few weeks.1

In some instances, these reactions may be related to factors other than insulin, such as

  • irritants in the skin cleansing agent or

  • poor injection technique.1

Systemic Allergy

Rare but potentially more serious, is generalized allergy to insulin, which may cause 

  • rash over the whole body

  • shortness of breath

  • wheezing

  • reduction in blood pressure

  • fast pulse, or

  • sweating.1

Severe cases of generalized allergy may be life-threatening.1

Spontaneous Reporting of Adverse Events

Spontaneous reporting of AEs can be highly variable because

  • there is not controlled clinical information on which to assess causality of a drug to an AE

  • there is bias in reporting, including incomplete information concerning the patient

  • the database may include reports of AEs for products that are available from a variety of manufacturers, and 

  • the database includes cases where verification that the product was manufactured by Lilly was not obtainable.2

As of April 30, 2017, hypersensitivity reactions from postmarketing experience have been very rarely (<0.01%) reported in association with Lilly’s insulin lispro products.2

The data contained in the postmarketing safety database does not represent the rate of occurrence of an AE; they merely represent the rate of reporting of a particular AE to the company.2


1. Humalog [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.


AE = adverse event

Lilly = Eli Lilly and Company

Date of Last Review: September 13, 2018

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