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Side Effects > Apidra

Apidra Side Effects

Please note - some side effects for Apidra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the professional

For the professional


Apidra

Overall, clinical studies comparing Apidra with short-acting insulins did not demonstrate a difference in frequency of adverse events.

Adverse events commonly associated with human insulin therapy include the following:

Body as a whole: allergic reactions.

Skin and appendages: injection site reaction, lipodystrophy, pruritus, rash.

Other: hypoglycemia.

The rates and incidence of severe symptomatic hypoglycemia, defined as hypoglycemia requiring intervention from a third party, were comparable for all treatment regimens.

Table 4: Severe Symptomatic Hypoglycemia
Type 1 Diabetes – Mellitus Adult 12 weeks in combination with Lantus®* Type 1 Diabetes Mellitus – Adult 26 weeks in combination with Lantus® Type 2 Diabetes Mellitus – Adult 26 weeks in combination with NPH human insulin
Apidra Pre-meal Apidra Post-meal Regular Human Insulin Apidra Humalog® Apidra Regular Human Insulin
*
Entire treatment phase (3 months) has been included.
Last three months of treatment have been considered.
Severe symptomatic hypoglycemia
(events/month/patient)
0.05 0.05 0.13 0.02 0.02 0.00 0.00
Severe symptomatic hypoglycemia
Percent of patients (n/total N)
8.4%
(24/286)
8.4%
(25/296)
10.1%
(28/278)
4.8%
(16/335)
4.0%
(13/326)
1.4%
(6/416)
1.2%
(5/420)

Continuous Subcutaneous Insulin Infusion (CSII) (Type 1 Diabetes): The rates of catheter occlusions and infusion site reactions were similar for Apidra and Novolog®.

Table 5: Catheter Occlusions and Infusion Site Reactions.
Apidra Novolog®
Catheter occlusions/month 0.08 0.15
Infusion site reactions 10.3% (3/29) 13.3% (4/30)

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More resources:

Drugs.com Apidra

PDR Apidra

Micromedex Apidra - Includes detailed dosage instructions.

FDA Apidra

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