65/100 · Elevated
Manufactured by Novo Nordisk
Moderate Safety Concerns with Insulin Detemir
67,881 FDA adverse event reports analyzed
Last updated: 2026-05-12
INSULIN DETEMIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. Based on analysis of 67,881 FDA adverse event reports, INSULIN DETEMIR 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 DETEMIR include BLOOD GLUCOSE INCREASED, NAUSEA, BLOOD GLUCOSE DECREASED, FATIGUE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INSULIN DETEMIR.
Insulin Detemir 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 67,881 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, 61.3% 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 acute kidney injury, hypoglycemia, and death are reported but less frequently. Weight changes and respiratory issues are also notable among the adverse events. Drug ineffectiveness and incorrect dose administration are significant concerns.
Patients taking Insulin Detemir should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Insulin Detemir may interact with other medications affecting blood glucose levels, and warnings include incorrect dose administration and drug ineffectiveness. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Insulin Detemir received a safety concern score of 65/100 (elevated concern). This is based on a 61.3% serious event ratio across 38,659 classified reports. The score accounts for 67,881 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: 21,201, Male: 15,399, Unknown: 79. The most frequently reported age groups are age 65 (901 reports), age 66 (763 reports), age 63 (742 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,659 classified reports for INSULIN DETEMIR:
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 Detemir may interact with other medications affecting blood glucose levels, and warnings include incorrect dose administration and drug ineffectiveness.
If you are taking Insulin Detemir, here are important things to know. The most commonly reported side effects include blood glucose increased, nausea, blood glucose decreased, fatigue, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor blood glucose levels closely to prevent hypoglycemia and hyperglycemia. Follow prescribed dosing instructions and consult healthcare providers for any concerns. 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.
Regulatory oversight is ongoing, with no major safety concerns but a need for careful monitoring and management of blood glucose levels.
The FDA has received approximately 67,881 adverse event reports associated with Insulin Detemir. 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 Detemir include Blood Glucose Increased, Nausea, Blood Glucose Decreased, Fatigue, Diarrhoea. By volume, the top reported reactions are: Blood Glucose Increased (6,220 reports), Nausea (1,971 reports), Blood Glucose Decreased (1,568 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 Detemir.
Out of 38,659 classified reports, 23,687 (61.3%) were classified as serious and 14,972 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 Detemir break down by patient sex as follows: Female: 21,201, Male: 15,399, Unknown: 79. 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 Detemir adverse events are: age 65: 901 reports, age 66: 763 reports, age 63: 742 reports, age 67: 716 reports, age 70: 712 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 Detemir 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 Detemir include: Drug Ineffective, Vomiting, Dyspnoea, Malaise, Fall. 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 Detemir 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 Detemir 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 Detemir's adverse event data include: Acute kidney injury and renal failure are key safety signals, indicating potential renal toxicity.. Hypoglycemia and hyperglycemia are frequent, highlighting the need for careful dose management.. Death and serious adverse events are reported, though less frequently.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Insulin Detemir may interact with other medications affecting blood glucose levels, and warnings include incorrect dose administration and drug ineffectiveness. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Insulin Detemir.
Monitor blood glucose levels closely to prevent hypoglycemia and hyperglycemia. Follow prescribed dosing instructions and consult healthcare providers for any concerns.
Insulin Detemir has 67,881 adverse event reports on file with the FDA. Serious adverse events such as acute kidney injury, hypoglycemia, and death are reported but less frequently. The volume of reports for Insulin Detemir reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with no major safety concerns but a need for careful monitoring and management of blood glucose levels. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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