ArticleThe journal of headache and pain2025
Adverse events associated with gepants: a pharmacovigilance analysis based on the FDA adverse event reporting system.
Article in The journal of headache and pain, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.Headache · 2026Pooled it
- Safety Profile of Zavegepant in the Treatment of Acute Migraine: Insights from the FDA Adverse Event Monitoring System Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Integrated Evidence from VigiBase and Clinical Trials: A Comprehensive Pharmacovigilance Analysis of Seven Glucagon-Like Peptide 1 Receptor Agonists (GLP-1 RAs).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study.Pain and therapy · 2026Article
- Adverse Events Associated with Tirzepatide: Updated Pharmacovigilance Analysis Using FAERS (2022 Q1-2025 Q1) with an Adapted Time-to-Onset Method.Drug, healthcare and patient safety · 2026Article
- Risk stratification of ibrutinib toxicity co-administered with triazole antifungals: insights from real-world pharmacovigilance and clinical evidence.Frontiers in medicine · 2026Article
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Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
backgroundGepants have demonstrated notable benefits in migraine therapy, yet their safety profiles are not thoroughly investigated. This study comprehensively analyzed the adverse event (AE) risk signals of the currently approved gepants using the U.S. Food and Drug Administration Adverse Event Reporting System database, aiming to gain better understanding of their post-marketing safety features and potential risks.
methodsAll data of the gepants (rimegepant, atogepant, ubrogepant, and zavegepant) from January 1st 2020 to December 31st 2024 were retrieved from the database. Descriptive analysis was conducted to characterize the features of gepant-associated AEs. Disproportionality analysis and subsequent sensitivity analysis were employed to evaluate the risk signals of the gepants utilizing the algorithms of reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC).
resultsA total of 7766 reports of rimegepant, 3672 reports of atogepant, 1958 reports of ubrogepant, and 463 reports of zavegepant were identified after data processing. Most AEs were occurred within 30 days after gepant administration. The integration of disproportionality analysis and sensitivity analysis indicated that "feeling abnormal" was the most reported AE of rimegepant (n = 185, 6.81%, ROR
conclusionsThe present pharmacovigilance study systematically revealed the significant risk signals of gepants. The common AEs and unique AEs of the four gepants were also identified and explored. Our results would provide valuable reference for the safe use of gepants, guiding personalized drug selection in clinical practice.
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