65/100 · Elevated
Manufactured by Novo Nordisk
Moderate Safety Concerns with Insulin Aspart
120,218 FDA adverse event reports analyzed
Last updated: 2026-05-12
INSULIN ASPART is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. Based on analysis of 120,218 FDA adverse event reports, INSULIN ASPART has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for INSULIN ASPART include BLOOD GLUCOSE INCREASED, NAUSEA, BLOOD GLUCOSE DECREASED, DRUG INEFFECTIVE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INSULIN ASPART.
Insulin Aspart has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 120,218 adverse event reports for this medication, which is primarily manufactured by Novo Nordisk.
The most commonly reported adverse events include Blood Glucose Increased, Nausea, Blood Glucose Decreased. Of classified reports, 62.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include increased and decreased blood glucose levels, nausea, and fatigue.
Serious adverse events such as death, acute kidney injury, and chronic kidney disease are reported. Weight changes and cardiovascular issues are also frequently reported.
Patients taking Insulin Aspart should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Insulin Aspart should be used with caution in patients with pre-existing renal or cardiovascular conditions. Close monitoring is required to prevent severe hypoglycemia and hyperglycemia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Insulin Aspart received a safety concern score of 65/100 (elevated concern). This is based on a 62.6% serious event ratio across 63,525 classified reports. The score accounts for 120,218 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 33,249, Male: 26,958, Unknown: 98. The most frequently reported age groups are age 65 (1,325 reports), age 66 (1,275 reports), age 68 (1,209 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,525 classified reports for INSULIN ASPART:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Insulin Aspart should be used with caution in patients with pre-existing renal or cardiovascular conditions. Close monitoring is required to prevent severe hypoglycemia and hyperglycemia.
If you are taking Insulin Aspart, here are important things to know. The most commonly reported side effects include blood glucose increased, nausea, blood glucose decreased, drug ineffective, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should closely monitor their blood glucose levels and report any significant changes to their healthcare provider. Follow prescribed dosing instructions and storage guidelines to prevent adverse reactions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Insulin Aspart. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 120,218 adverse event reports associated with Insulin Aspart. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Insulin Aspart include Blood Glucose Increased, Nausea, Blood Glucose Decreased, Drug Ineffective, Fatigue. By volume, the top reported reactions are: Blood Glucose Increased (10,428 reports), Nausea (3,722 reports), Blood Glucose Decreased (3,346 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Insulin Aspart.
Out of 63,525 classified reports, 39,772 (62.6%) were classified as serious and 23,753 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Insulin Aspart break down by patient sex as follows: Female: 33,249, Male: 26,958, Unknown: 98. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Insulin Aspart adverse events are: age 65: 1,325 reports, age 66: 1,275 reports, age 68: 1,209 reports, age 70: 1,196 reports, age 63: 1,193 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Insulin Aspart adverse event reports is Novo Nordisk. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Insulin Aspart include: Dyspnoea, Diarrhoea, Vomiting, Dizziness, Off Label Use. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Insulin Aspart to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Insulin Aspart has a safety concern score of 65 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common reactions include increased and decreased blood glucose levels, nausea, and fatigue.
Key safety signals identified in Insulin Aspart's adverse event data include: High frequency of hypoglycemia and hyperglycemia reports.. Significant number of serious events including death and renal failure.. Multiple reports of cardiovascular issues like myocardial infarction and congestive heart failure.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Insulin Aspart should be used with caution in patients with pre-existing renal or cardiovascular conditions. Close monitoring is required to prevent severe hypoglycemia and hyperglycemia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Insulin Aspart.
Patients should closely monitor their blood glucose levels and report any significant changes to their healthcare provider. Follow prescribed dosing instructions and storage guidelines to prevent adverse reactions.
Insulin Aspart has 120,218 adverse event reports on file with the FDA. Serious adverse events such as death, acute kidney injury, and chronic kidney disease are reported. The volume of reports for Insulin Aspart reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Insulin Aspart. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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