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POST-MARKETING SAFETY EVALUATION OF ATOGEPANT FOR MIGRAINE PREVENTION: A COMPREHENSIVE REAL-WORLD PHARMACOVIGILANCE AND SIGNAL DETECTION STUDY

AZFAR ATHAR ISHAQUI 1*, ADNAN IQBAL 2, AYESHA PERVEZ 3, MUHAMMAD IMRAN 4, HABIB AHMAD QURESHI 5, ADNAN JEHANGIR 3, JAVERIA FAROOQ 6, KHALID ORAYJ 1, SULTAN M. ALSHAHRANI 1, NARENDAR KUMAR 7, SHOAIB ALAM 2, SALMAN ASHFAQ AHMAD 4, MUHAMMAD BILAL MAQSOOD ⁸

¹ Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha 62583, Saudi Arabia
2 Department of Pharmacology, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi 75270, Pakistan
3 Department of Biomedical Science, College of Medicine, King Faisal University, Al Ahsa 31982, Saudi Arabia
4 Faculty of Pharmacy, Iqra University, Karachi 75850, Pakistan
5 Mohammad Almana College of Medical Sciences, Dammam 34222, Saudi Arabia
6 Department of Pharmacognosy, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi 75270, Pakistan
7 Department of Pharmacy Practice, Faculty of Pharmacy, University of Sindh, Jamshoro 76080, Pakistan
8 Quality and Performance Administration, Eastern Health Cluster, Health Holding Company, Dammam 32253, Saudi Arabia

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This study evaluated atogepant-associated reports in the FDA Adverse Event Reporting System from Q4 2021 to Q1 2026. After deduplication, 4,819 reports listed atogepant as the primary suspect drug, containing 11,287 reaction records across 1,356 distinct MedDRA Preferred Terms (PTs). Disproportionality analyses used ROR, PRR, IC and EBGM, with signal positivity based on conservative lower confidence-bound metrics. Most reports involved females (76.22%) and originated from the United States (90.29%). The most frequent PTs were “migraine”, “drug ineffective”, “headache, nausea” and “constipation”. A total of 137 PTs met all conservative signal criteria. Top EBGM05-ranked signals included migraine, hemiplegic migraine and vestibular migraine. Selected reproductive, menstrual, autonomic and sensory signals were observed, including Raynaud's phenomenon, POTS, menstrual irregularities, hyperacusis and tinnitus. Congenital-keyword PTs were rare. These findings provide atogepant-specific post-marketing safety evidence but remain hypothesis-generating and require confirmation in prospective studies.