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).
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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.
| 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 | |
| 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®‡.
| Apidra | Novolog®‡ | |
|---|---|---|
| Catheter occlusions/month | 0.08 | 0.15 |
| Infusion site reactions | 10.3% (3/29) | 13.3% (4/30) |
More resources:
Apidra - Includes detailed dosage instructions.
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