Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data
Abstract
OBJECTIVE: Calcitonin gene-related peptide (CGRP) inhibitors, including monoclonal antibodies (mAbs) and small-molecule antagonists (gepants), have transformed migraine treatment. Although clinical trials established their efficacy and initial safety, post-marketing surveillance is essential for understanding their real-world safety profile in a broader population. Therefore, this study aims to systematically review and synthesize findings from published pharmacovigilance studies that analyze potential safety signals for CGRP inhibitors using major international databases, including the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), the World Health Organization's (WHO's) VigiBase, and EudraVigilance, in order to establish a comprehensive real-world safety profile to guide clinical practice.
METHODS: A systematic search was conducted in major electronic databases for studies published up to September 2025. Study selection, data extraction, and quality assessment were performed by two independent researchers. We included original research articles analyzing FAERS, VigiBase, or EudraVigilance for AEs associated with erenumab, galcanezumab, fremanezumab, eptinezumab, rimegepant, ubrogepant, atogepant, or zavegepant. Data on key signals of disproportionate reporting (SDRs) and quantitative measures of disproportionality were extracted and synthesized thematically.
RESULTS: The search identified 30 eligible studies. For mAbs, consistent…
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