35/100 · Moderate
Manufactured by Amgen Inc
Erenumab-AOOE Adverse Events: Mostly Non-Serious, with Common Device-Related Issues
151,566 FDA adverse event reports analyzed
Last updated: 2026-05-12
ERENUMAB AOOE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen Inc. Based on analysis of 151,566 FDA adverse event reports, ERENUMAB AOOE 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 ERENUMAB AOOE include ACCIDENTAL EXPOSURE TO PRODUCT, DEVICE DIFFICULT TO USE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, DRUG DOSE OMISSION BY DEVICE, MIGRAINE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ERENUMAB AOOE.
Erenumab-Aooe 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 151,566 adverse event reports for this medication, which is primarily manufactured by Amgen Inc.
The most commonly reported adverse events include Accidental Exposure To Product, Device Difficult To Use, Wrong Technique In Product Usage Process. Of classified reports, 20.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, with device-related issues being the most common.
Headache and constipation are among the top reported side effects. There is a notable number of serious adverse events, primarily related to device issues and drug ineffectiveness. The reaction diversity is high, with over 100 distinct reactions reported. The highest volume of reports is for accidental exposure to the product and device difficulties.
Patients taking Erenumab-Aooe should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Device-related issues are a significant safety concern, with reports of drug dose omission and accidental exposure. Consumers should be cautious and follow the device instructions carefully. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Erenumab-Aooe received a safety concern score of 35/100 (moderate concern). This is based on a 20.3% serious event ratio across 53,229 classified reports. The score accounts for 151,566 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: 37,379, Male: 6,148, Unknown: 19. The most frequently reported age groups are age 40 (1,555 reports), age 43 (1,473 reports), age 50 (825 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,229 classified reports for ERENUMAB AOOE:
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.
Device-related issues are a significant safety concern, with reports of drug dose omission and accidental exposure. Consumers should be cautious and follow the device instructions carefully.
If you are taking Erenumab-Aooe, here are important things to know. The most commonly reported side effects include accidental exposure to product, device difficult to use, wrong technique in product usage process, drug dose omission by device, migraine. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the device instructions carefully to avoid drug dose omission and accidental exposure. Report any serious adverse events to the manufacturer or the FDA. 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 Erenumab-AOOE, and any serious adverse events should be reported to the manufacturer or the FDA.
The FDA has received approximately 151,566 adverse event reports associated with Erenumab-Aooe. 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 Erenumab-Aooe include Accidental Exposure To Product, Device Difficult To Use, Wrong Technique In Product Usage Process, Drug Dose Omission By Device, Migraine. By volume, the top reported reactions are: Accidental Exposure To Product (10,036 reports), Device Difficult To Use (9,770 reports), Wrong Technique In Product Usage Process (9,454 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Erenumab-Aooe.
Out of 53,229 classified reports, 10,802 (20.3%) were classified as serious and 42,427 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 Erenumab-Aooe break down by patient sex as follows: Female: 37,379, Male: 6,148, Unknown: 19. 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 Erenumab-Aooe adverse events are: age 40: 1,555 reports, age 43: 1,473 reports, age 50: 825 reports, age 52: 804 reports, age 57: 797 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 Erenumab-Aooe adverse event reports is Amgen 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 Erenumab-Aooe include: Drug Ineffective, Headache, Constipation, Product Storage Error, Injection Site Pain. 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 Erenumab-Aooe 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.
Erenumab-Aooe 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. The majority of adverse events are non-serious, with device-related issues being the most common.
Key safety signals identified in Erenumab-Aooe's adverse event data include: Device issues and drug dose omission are the most frequent adverse events.. Headache and constipation are the most common side effects.. Serious adverse events, particularly related to device use, are a concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Device-related issues are a significant safety concern, with reports of drug dose omission and accidental exposure. Consumers should be cautious and follow the device instructions carefully. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Erenumab-Aooe.
Follow the device instructions carefully to avoid drug dose omission and accidental exposure. Report any serious adverse events to the manufacturer or the FDA.
Erenumab-Aooe has 151,566 adverse event reports on file with the FDA. Headache and constipation are among the top reported side effects. The volume of reports for Erenumab-Aooe reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Erenumab-AOOE, and any serious adverse events should be reported to the manufacturer or the FDA. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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