Disproportionality Analysis of Somatropin-Related Adverse Events Using KAERS and Online Patient Reviews

BK21 FOUR Community-Based Intelligent Novel Drug Discovery Education Unit, College of Pharmacy and Research Institute of Pharmaceutical Sciences, Daegu, Republic of Korea This study examined the value of combining structured regulatory reports and unstructured patient narratives to enhance pharmacovigilance of somatropin. Adverse event(AE) records were obtained from the Korea Adverse Event Reporting System (KAERS) and patient reviews from NAVER Jisik-In. Disproportionality analyses were performed on KAERS data (KIDS-KAERS DB, 2410A0003), while online AEs were coded with Medical Dictionary for Regulatory Activities(MedDRA) and assessed using World Health Organization–Uppsala Monitoring Centre criteria(WHO-UMC). We identified 29 potential AEs from KAERS not listed in approved labels, including viral infections, injection-site reactions, administration errors, device and procedure-related issues, and fractures. In contrast, online reviews more frequently revealed appearance-related and psychological concerns—such as acne, weight change, gynecomastia, anxiety, precocious puberty, and delayed secondary sexual characteristics—that were not detected as statistically significant AEs in KAERS. These findings demonstrate that integrating spontaneous reports with patient narratives yields complementary safety information and provides a more comprehensive profile of somatropin, underscoring the importance of patient-centered data in pharmacovigilance, particularly for off-label pediatric use, while also highlighting blind spots in traditional reporting systems and underscoring the value of multi-source safety monitoring.