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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ERENUMAB-AOOE: 50,133 Adverse Event Reports & Safety Profile

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50,133
Total FAERS Reports
1,935 (3.9%)
Deaths Reported
3,054
Hospitalizations
50,133
As Primary/Secondary Suspect
1,690
Life-Threatening
2,059
Disabilities
Prescription
Status

FDA Application: 761077 ·

First Report: 19630425 · Latest Report: 20250929

What Are the Most Common ERENUMAB-AOOE Side Effects?

#1 Most Reported
Accidental exposure to product
9,923 reports (19.8%)
#2 Most Reported
Device difficult to use
9,530 reports (19.0%)
#3 Most Reported
Wrong technique in product usage process
9,359 reports (18.7%)

All ERENUMAB-AOOE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Accidental exposure to product 9,923 19.8% 1 40
Device difficult to use 9,530 19.0% 3 109
Wrong technique in product usage process 9,359 18.7% 1 80
Drug dose omission by device 6,340 12.7% 1 74
Migraine 4,290 8.6% 468 736
Drug ineffective 3,813 7.6% 577 648
Constipation 3,104 6.2% 2 174
Product storage error 2,958 5.9% 0 23
Headache 2,787 5.6% 517 681
Injection site pain 2,715 5.4% 2 50
Off label use 2,227 4.4% 983 962
Nausea 1,929 3.9% 512 612
Alopecia 1,924 3.8% 621 589
Fatigue 1,829 3.7% 530 590
Therapeutic product effect incomplete 1,761 3.5% 265 264
Dizziness 1,467 2.9% 530 549
Pain 1,442 2.9% 655 668
Device issue 1,242 2.5% 0 5
Muscle spasms 1,229 2.5% 531 516
Arthralgia 1,227 2.5% 620 571

Who Reports ERENUMAB-AOOE Side Effects? Age & Gender Data

Gender: 86.2% female, 13.8% male. Average age: 50.2 years. Most reports from: US. View detailed demographics →

Is ERENUMAB-AOOE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 0
2004 2 0 0
2008 6 0 1
2009 2 0 0
2013 2 0 1
2014 6 0 2
2015 20 18 18
2016 2 0 0
2017 11 6 9
2018 8,706 48 269
2019 6,318 35 306
2020 4,745 25 165
2021 4,003 17 90
2022 3,397 19 78
2023 3,880 15 95
2024 2,846 6 86
2025 671 8 31

View full timeline →

What Is ERENUMAB-AOOE Used For?

IndicationReports
Product used for unknown indication 19,343
Migraine 19,137
Migraine prophylaxis 9,326
Headache 902
Migraine without aura 858
Migraine with aura 198
Rheumatoid arthritis 153
Off label use 116
Cluster headache 71
Foetal exposure during pregnancy 71

ERENUMAB-AOOE vs Alternatives: Which Is Safer?

ERENUMAB-AOOE vs ERENUMAB\ERENUMAB-AOOE ERENUMAB-AOOE vs ERGOCALCIFEROL ERENUMAB-AOOE vs ERGOCALCIFEROL\PHYTONADIONE\RETINOL\TOCOPHEROL ERENUMAB-AOOE vs ERIBULIN ERENUMAB-AOOE vs ERLOTINIB ERENUMAB-AOOE vs ERTAPENEM ERENUMAB-AOOE vs ERTUGLIFLOZIN PIDOLATE ERENUMAB-AOOE vs ERYTHROMYCIN ERENUMAB-AOOE vs ERYTHROMYCIN ETHYLSUCCINATE ERENUMAB-AOOE vs ERYTHROMYCIN LACTOBIONATE

Official FDA Label for ERENUMAB-AOOE

Official prescribing information from the FDA-approved drug label.