Junchen Chen, Shunqiu Huang, Yashi Chen, Cheng Luo, Yong Li

Department of Neurosurgery, the First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People’s Republic of China

Correspondence: Yong Li, Email yli8@stu.edu.cn

Introduction: Triptans are the only FDA-approved migraine-specific treatment for pediatric patients, yet comprehensive real-world safety data remains limited, particularly regarding rare adverse events and age-specific safety profiles.
Methods and Materials: We conducted a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database from 2004– 2024, focusing on adverse events associated with sumatriptan, rizatriptan, zolmitriptan, and almotriptan in patients aged 6– 18 years. After systematic deduplication following FDA guidelines, disproportionality analysis was performed using reporting odds ratios (ROR) and risk-signal detection ratios (RSDR). Subgroup analyses compared safety signals between children (6– 11 years) and adolescents (12– 18 years) at both Preferred Terms and System Organ Class levels.
Results: Among 19,557 triptan-related cases in FAERS, 375 (1.9%) were pediatric cases, predominantly female (70.7%) and aged 12– 18 years (91.2%). Sumatriptan was most frequently reported (77.3%), followed by rizatriptan (17.9%). Significant safety signals included posterior reversible encephalopathy syndrome with sumatriptan (ROR=86.69, 95% CI=26.6– 282.54), acute respiratory failure with rizatriptan (ROR=98.12, 95% CI=40.17– 239.64), and renal infarction with zolmitriptan (ROR=2231.93, 95% CI=667.65– 7461.24). Age-stratified analysis revealed distinct profiles: younger children (6– 11 years) showed higher risks for gastric emptying impairment (ROR=331.24) and throat tightness (ROR=77.14), while adolescents (12– 18 years) experienced more diverse adverse events, notably pharyngeal swelling (ROR=133.81) and chest discomfort (ROR=19.05).
Conclusion: Real-world triptan safety profiles reveal age-specific risks in pediatric populations, emphasizing the need for tailored monitoring strategies and age-appropriate safety protocols.

Keywords: triptans, faers, migraine, pediatric, pharmacovigilance, adverse events