ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Neuropharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1647088
Assessment of Drug-Related Migraine in a Real-World Large-Scale Database
Provisionally accepted
- 1Shandong University of Traditional Chinese Medicine, Jinan, China
- 2Shanghai Academy of Social Sciences, Shanghai, China
- 3Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan, China
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Background: Drug-induced migraine represents a clinically significant yet under-investigated subtype of migraine. This study aims to evaluate the risk of drug-related migraine based on real-world data from the FDA Adverse Event Reporting System (FAERS). Methods: A retrospective pharmacovigilance analysis was conducted using FAERS data from Q1 2004 to Q4 2024. Migraine cases were identified via standardized MedDRA (The Medical Dictionary for Regulatory Activities) terms. Only primary suspect drugs were included. Disproportionality analyses were performed using four algorithms: ROR, PRR, MGPS, and BCPNN. Drugs were classified by therapeutic indication and mechanism of action, and stratified by BCPNN values to assess risk levels. Results: A total of 20,886 migraine-related adverse events were identified, predominantly among females (77.4%) with a mean age of 45.7 years. Sixty-six drugs yielded positive signals, and after exclusion criteria, 39 remained for further analysis. The highestrisk agents included lorcaserin (BCPNN = 3.33), tasimelteon (3.20), and botulinum toxin type A (3.06).High-risk therapeutic classes included immunosuppressants, estrogens/progestogens, and sedativehypnotics. Conclusions: This large-scale analysis identifies key drug categories and compounds associated with an elevated risk of migraine, providing actionable insights for clinicians. Especially lorcaserin, tasimelteon, and botulinum toxin as potential risk factors for migraine. Given the public health burden of migraine, pharmacovigilance efforts should incorporate such findings to mitigate iatrogenic risks. Further prospective studies are warranted to establish causal mechanisms and optimize therapeutic decision-making.
Keywords: Migraine, drug-induced headache, FAERS, Pharmacovigilance, Disproportionality analysis, BCPNN
Received: 14 Jun 2025; Accepted: 17 Jul 2025.
Copyright: © 2025 Wu, Liu, Jiang and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Fan Wu, Shandong University of Traditional Chinese Medicine, Jinan, China
Zhonglin Wang, Shandong University of Traditional Chinese Medicine, Jinan, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.