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Home Articles Vol 30,2026 No.3 Detail

Analysis of the safety profile of zavegepant based on the FAERS database and comparison with CGRP-targeted drugs

Published on Apr. 02, 2026Total Views: 20 times Total Downloads: 4 times Download Mobile

Author: XIE Jinlian 1# WANG Qing 2# ZHANG Xingfei 1 ZHANG Yaxin 1 WU Qian 1 MA Junlong 1 KUANG Yun 1 GUO Chengxian 1

Affiliation: 1. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha 410013, China 2. Center for Medical Information, The Third Xiangya Hospital, Central South University, Changsha 410013, China

Keywords: Calcitonin gene-related peptide-targeted medication Zavegepant FAERS database Signal mining Disproportionality analysis Bayesian confidence propagation neural network Adverse events Pharmacovigilance

DOI: 10.12173/j.issn.2097-4922.202511062

Reference: XIE Jinlian, WANG Qing, ZHANG Xingfei, ZHANG Yaxin, WU Qian, MA Junlong, KUANG Yun, GUO Chengxian. Analysis of the safety profile of zavegepant based on the FAERS database and comparison with CGRP-targeted drugs[J]. Yaoxue QianYan Zazhi, 2026, 30(3): 455-465. DOI: 10.12173/j.issn.2097-4922.202511062.[Article in Chinese]

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Abstract

Objective  To analyze the real-world adverse event (AE) profile of zavegepant and compare it with other calcitonin gene-related peptide (CGRP)-targeted medications using the FDA Adverse Event Reporting System (FAERS) database.

Methods  AE reports of eight CGRP-targeted medications were extracted from the FAERS database from the fourth quarter of 2014 to the fourth quarter of 2024. Disproportionality analyses were conducted using the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network (BCPNN) to detect significant AE signals. The Bradford Hill criteria were applied to evaluate the plausibility of a causal relationship for the key signals.

Results  Among 13,560,472 unique AE reports, 489 were associated with zavegepant. Signal detection identified 37 significant preferred terms (PTs) across 8 system organ classes (SOCs). AEs were reported approximately six times more frequently in female patients. Zavegepant-related AEs predominantly occurred on the day of admin-istration. The strongest signals included dysgeusia (IC025=6.34, ROR025=82.13) and nasal discomfort (IC025=6.17, ROR025=74.42). Novel signals included photophobia and hyperacusis, which was consistent with the drug instructions. Positive signals for adverse pregnancy outcomes were identified for rimegepant, ubrogepant, fremanezumab, and erenumab.

Conclusion  The safety profile of zavegepant is characterized by rapid-onset sensory AEs consistent with its intranasal administration route. Newly identified ocular and auditory signals necessitate enhanced pharmacovigilance. The application of Bradford Hill criteria suggests a plausible causal link for these sensory events. The potential risk of adverse pregnancy outcomes associated with multiple CGRP-targeted drugs, thus the benefits and risks should be strictly evaluated when administering these drugs to women of childbearing age in clinical practice.

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