35/100 · Moderate
Manufactured by Amgen USA Inc.
Evolocumab Adverse Events: Common Device-Related Issues and Mild to Moderate Reactions
266,603 FDA adverse event reports analyzed
Last updated: 2026-05-12
EVOLOCUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen USA Inc.. Based on analysis of 266,603 FDA adverse event reports, EVOLOCUMAB has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for EVOLOCUMAB include DEVICE DIFFICULT TO USE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, ACCIDENTAL EXPOSURE TO PRODUCT, INJECTION SITE PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EVOLOCUMAB.
Evolocumab has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 266,603 adverse event reports for this medication, which is primarily manufactured by Amgen Usa Inc..
The most commonly reported adverse events include Device Difficult To Use, Drug Dose Omission By Device, Wrong Technique In Product Usage Process. Of classified reports, 15.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most common reactions include device-related issues and mild to moderate pain and discomfort.
Serious adverse events are relatively rare, comprising about 15.4% of total reports. The majority of reactions are non-serious, with the most frequent being injection site pain and back pain.
Patients taking Evolocumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are not prominently featured in the data, but patients should be cautious with device use and ensure proper technique to avoid errors. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Evolocumab received a safety concern score of 35/100 (moderate concern). This is based on a 15.4% serious event ratio across 155,053 classified reports. The score accounts for 266,603 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 83,572, Male: 59,962, Unknown: 65. The most frequently reported age groups are age 70 (4,197 reports), age 71 (4,093 reports), age 69 (4,087 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 155,053 classified reports for EVOLOCUMAB:
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 are not prominently featured in the data, but patients should be cautious with device use and ensure proper technique to avoid errors.
If you are taking Evolocumab, here are important things to know. The most commonly reported side effects include device difficult to use, drug dose omission by device, wrong technique in product usage process, accidental exposure to product, injection site pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should follow the prescribed device usage instructions carefully to minimize the risk of device-related issues. Report any adverse events to healthcare providers promptly for appropriate management. 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 profile of evolocumab, and the drug remains approved for use in managing hypercholesterolemia.
The FDA has received approximately 266,603 adverse event reports associated with Evolocumab. 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 Evolocumab include Device Difficult To Use, Drug Dose Omission By Device, Wrong Technique In Product Usage Process, Accidental Exposure To Product, Injection Site Pain. By volume, the top reported reactions are: Device Difficult To Use (32,421 reports), Drug Dose Omission By Device (24,327 reports), Wrong Technique In Product Usage Process (21,878 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Evolocumab.
Out of 155,053 classified reports, 23,842 (15.4%) were classified as serious and 131,211 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 Evolocumab break down by patient sex as follows: Female: 83,572, Male: 59,962, Unknown: 65. 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 Evolocumab adverse events are: age 70: 4,197 reports, age 71: 4,093 reports, age 69: 4,087 reports, age 74: 4,063 reports, age 73: 4,054 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 Evolocumab adverse event reports is Amgen Usa Inc.. 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 Evolocumab include: Product Storage Error, Back Pain, Myalgia, Drug Dose Omission, Injection Site Bruising. 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 Evolocumab 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.
Evolocumab has a safety concern score of 35 out of 100 (moderate 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. Most common reactions include device-related issues and mild to moderate pain and discomfort.
Key safety signals identified in Evolocumab's adverse event data include: Device use errors and device issues are the most frequent types of adverse events.. Injection site reactions, including bruising and erythema, are commonly reported.. Pain and discomfort, such as myalgia and arthralgia, are also frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are not prominently featured in the data, but patients should be cautious with device use and ensure proper technique to avoid errors. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Evolocumab.
Patients should follow the prescribed device usage instructions carefully to minimize the risk of device-related issues. Report any adverse events to healthcare providers promptly for appropriate management.
Evolocumab has 266,603 adverse event reports on file with the FDA. Serious adverse events are relatively rare, comprising about 15.4% of total reports. The volume of reports for Evolocumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of evolocumab, and the drug remains approved for use in managing hypercholesterolemia. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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