New Insight on the Safety of Erenumab: An Analysis of Spontaneous Reports of Adverse Events Recorded in the US Food and Drug Administration Adverse Event Reporting System Database



The aim of this article was to provide an overview of adverse events reported for erenumab in post-marketing through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and perform a disproportionality analysis with other drugs used for acute or preventative treatment of migraine as controls.


FAERS was screened from the first quarter of 2018 to the second quarter of 2020 (latest data update 30 June 2020). Clinical and demographic characteristics of cases were described along with the seriousness and outcome of adverse events. Disproportionality analyses were performed using the reporting odds ratio (ROR).


In total, 23,312 cases were reported during the study period, 67.0% by consumers. Cases in the age range 18–64 years (10,922 cases; 45.8%), in female sex (15,099 cases; 64.8%), and with adverse events that were classified as non-serious (19,626 cases; 84.2%) were the most prevalent in the database. After the exclusion of duplicates, 146 fatal cases were identified. A total of 1303 unlabeled adverse events were reported, of which 49 had statistically significant disproportionality of reporting in comparison with other drugs used for acute or preventative treatment of migraine. Identified disproportionality signals included alopecia, depression, anxiety, myocardial infarction, increased heart rate, pulmonary embolism, weight alteration, insomnia, tinnitus, and influenza-like symptoms. Injection-site reactions (labeled events) were co-reported with errors in administration procedures.


Adverse events reported during the first 2 years of post-marketing surveillance were mostly non-serious and with a favorable prognosis. However, new safety aspects emerged for which further studies are needed to confirm the associations, prioritizing unlabeled events with consistent disproportionality signals (e.g., emerging in at least 4 out of 6 analyses).

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Drafting the work and revising it for important intellectual content: MS and MA. Substantial contributions to the acquisition, analysis, or interpretation of data for the work: MS. Final approval of the version to be published: MS and MA. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: MS and MA. Developed the concept and designed the study: MS. Wrote the paper: MS.

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Correspondence to Maurizio Sessa.

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MS and MA belong to the Pharmacovigilance Research Center, Department of Drug Design and Pharmacology, University of Copenhagen, supported by a grant from the Novo Nordisk Foundation (NNF15SA0018404).

Conflict of interest

Morten Andersen has during the past 5 years participated in research projects supported by grants from Novartis, Pfizer, Janssen, AstraZeneca, and H. Lundbeck & Mertz, received by the universities where he has been employed. He has personally received fees from Atrium Education, the Danish Pharmaceutical Industry Association, for teaching and leading pharmacoepidemiology courses. Maurizio Sessa has no conflicts of interest to declare.

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No ethical approval is required for descriptive studies using publicly available data from FAERS.

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The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Code is available from the corresponding author on reasonable request.

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Sessa, M., Andersen, M. New Insight on the Safety of Erenumab: An Analysis of Spontaneous Reports of Adverse Events Recorded in the US Food and Drug Administration Adverse Event Reporting System Database. BioDrugs (2021).

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