65/100 · Elevated
Manufactured by sanofi-aventis U.S. LLC
Moderate Safety Concerns with Insulin Glargine
399,332 FDA adverse event reports analyzed
Last updated: 2026-05-12
INSULIN GLARGINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by sanofi-aventis U.S. LLC. Based on analysis of 399,332 FDA adverse event reports, INSULIN GLARGINE 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 GLARGINE include BLOOD GLUCOSE INCREASED, OFF LABEL USE, BLOOD GLUCOSE DECREASED, DRUG INEFFECTIVE, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INSULIN GLARGINE.
Insulin Glargine 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 399,332 adverse event reports for this medication, which is primarily manufactured by Sanofi-Aventis U.S. Llc.
The most commonly reported adverse events include Blood Glucose Increased, Off Label Use, Blood Glucose Decreased. Of classified reports, 52.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are increased and decreased blood glucose levels, indicating potential issues with dosing and administration.
Serious adverse events, such as death and cerebrovascular accident, are reported, highlighting significant risks. Drug interactions and device issues are frequent, necessitating careful monitoring and management.
Patients taking Insulin Glargine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Insulin Glargine can interact with other medications and may require adjustments in dosage. Device issues and improper storage can also lead to adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Insulin Glargine received a safety concern score of 65/100 (elevated concern). This is based on a 52.3% serious event ratio across 236,116 classified reports. The score accounts for 399,332 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: 120,024, Male: 98,720, Unknown: 733. The most frequently reported age groups are age 65 (5,145 reports), age 70 (4,885 reports), age 66 (4,794 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 236,116 classified reports for INSULIN GLARGINE:
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 Glargine can interact with other medications and may require adjustments in dosage. Device issues and improper storage can also lead to adverse events.
If you are taking Insulin Glargine, here are important things to know. The most commonly reported side effects include blood glucose increased, off label use, blood glucose decreased, drug ineffective, inappropriate schedule of product administration. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow the prescribed dosing schedule and monitor their blood glucose levels regularly. Inform healthcare providers about any other medications or devices being used to avoid potential interactions. 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 Glargine and has not issued any specific warnings or recalls. However, healthcare providers should remain vigilant and report any adverse events.
The FDA has received approximately 399,332 adverse event reports associated with Insulin Glargine. 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 Glargine include Blood Glucose Increased, Off Label Use, Blood Glucose Decreased, Drug Ineffective, Inappropriate Schedule Of Product Administration. By volume, the top reported reactions are: Blood Glucose Increased (38,215 reports), Off Label Use (11,497 reports), Blood Glucose Decreased (10,314 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 Glargine.
Out of 236,116 classified reports, 123,494 (52.3%) were classified as serious and 112,622 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 Glargine break down by patient sex as follows: Female: 120,024, Male: 98,720, Unknown: 733. 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 Glargine adverse events are: age 65: 5,145 reports, age 70: 4,885 reports, age 66: 4,794 reports, age 68: 4,698 reports, age 67: 4,652 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 Glargine adverse event reports is Sanofi-Aventis U.S. Llc. 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 Glargine include: Nausea, Product Storage Error, Visual Impairment, Hypoglycaemia, Diarrhoea. 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 Glargine 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 Glargine 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 are increased and decreased blood glucose levels, indicating potential issues with dosing and administration.
Key safety signals identified in Insulin Glargine's adverse event data include: High incidence of hypoglycemia and hyperglycemia suggests potential for severe glucose control issues.. Multiple reports of cardiovascular events, including myocardial infarction and stroke, indicate cardiovascular safety concerns.. Significant number of serious adverse events, including renal and pulmonary issues, warrant close monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Insulin Glargine can interact with other medications and may require adjustments in dosage. Device issues and improper storage can also lead to adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Insulin Glargine.
Patients should strictly follow the prescribed dosing schedule and monitor their blood glucose levels regularly. Inform healthcare providers about any other medications or devices being used to avoid potential interactions.
Insulin Glargine has 399,332 adverse event reports on file with the FDA. Serious adverse events, such as death and cerebrovascular accident, are reported, highlighting significant risks. The volume of reports for Insulin Glargine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Insulin Glargine and has not issued any specific warnings or recalls. However, healthcare providers should remain vigilant and report any adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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