82/100 · Critical
Manufactured by Professional Complementary Health Formulas
Insulin Adverse Events: High Seriousness and Diverse Reactions
106,119 FDA adverse event reports analyzed
Last updated: 2026-05-12
INSULIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Professional Complementary Health Formulas. Based on analysis of 106,119 FDA adverse event reports, INSULIN has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for INSULIN include BLOOD GLUCOSE INCREASED, DRUG INEFFECTIVE, NAUSEA, DYSPNOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for INSULIN.
Insulin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 106,119 adverse event reports for this medication, which is primarily manufactured by Professional Complementary Health Formulas.
The most commonly reported adverse events include Blood Glucose Increased, Drug Ineffective, Nausea. Of classified reports, 77.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with 77.5% of reports being classified as such.
A wide range of reactions are reported, indicating diverse safety concerns. Report volume is substantial, with over 100,000 total reports.
Patients taking Insulin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and off-label use are common, warranting caution and adherence to prescribed protocols. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Insulin received a safety concern score of 82/100 (high concern). This is based on a 77.5% serious event ratio across 55,470 classified reports. The score accounts for 106,119 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 27,463, Male: 25,016, Unknown: 158. The most frequently reported age groups are age 65 (1,241 reports), age 60 (1,237 reports), age 67 (1,133 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,470 classified reports for INSULIN:
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.
Drug interactions and off-label use are common, warranting caution and adherence to prescribed protocols.
If you are taking Insulin, here are important things to know. The most commonly reported side effects include blood glucose increased, drug ineffective, nausea, dyspnoea, fatigue. 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 and report any unusual symptoms to healthcare providers. Follow prescribed dosing instructions and avoid self-adjustment without medical advice. 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 robust, with ongoing monitoring and updates to safety guidelines.
The FDA has received approximately 106,119 adverse event reports associated with Insulin. 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 include Blood Glucose Increased, Drug Ineffective, Nausea, Dyspnoea, Fatigue. By volume, the top reported reactions are: Blood Glucose Increased (3,581 reports), Drug Ineffective (2,869 reports), Nausea (2,838 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.
Out of 55,470 classified reports, 43,011 (77.5%) were classified as serious and 12,459 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 break down by patient sex as follows: Female: 27,463, Male: 25,016, Unknown: 158. 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 adverse events are: age 65: 1,241 reports, age 60: 1,237 reports, age 67: 1,133 reports, age 63: 1,116 reports, age 68: 1,078 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 adverse event reports is Professional Complementary Health Formulas. 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 include: Diarrhoea, Pain, Vomiting, Asthenia, Dizziness. 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 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 has a safety concern score of 82 out of 100 (high 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 majority of adverse events are serious, with 77.5% of reports being classified as such.
Key safety signals identified in Insulin's adverse event data include: High percentage of serious adverse events (77.5%).. Diverse reactions include cardiovascular, neurological, and gastrointestinal issues.. Reported drug interactions and off-label use are significant.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and off-label use are common, warranting caution and adherence to prescribed protocols. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Insulin.
Monitor blood glucose levels closely and report any unusual symptoms to healthcare providers. Follow prescribed dosing instructions and avoid self-adjustment without medical advice.
Insulin has 106,119 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Insulin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is robust, with ongoing monitoring and updates to safety guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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