Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases.

Background: Somatrogon, a long-acting recombinant human growth hormone, is used in children with growth hormone deficiency. While clinical trials have shown its safety, real-world post-marketing data are limited, and uncommon or delayed adverse events (AEs) may not be fully recognized. Methods: We analyzed somatrogon-related AEs from the US FDA Adverse Event Reporting System (FAERS) (Q1 2004-Q2 2025) and the WHO global safety database via VigiAccess (up to Dec 2024). Disproportionality analyses were performed using four signal detection methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). AEs were assessed at both system organ class and preferred term (PT) levels. In FAERS, time to onset was examined to characterize the temporal pattern. Results: We identified 1,001 somatrogon-related reports in FAERS and 863 in VigiAccess. Most cases occurred in pediatric patients, with slightly more reports in males. At the SOC level, most AEs involved general disorders, administration site conditions, injuries, and product issues. At the PT level, recurring signals included injection-site reactions, device-related problems, and insulin-like growth factor abnormalities. Among 168 FAERS cases with valid onset data, 79.76% occurred within 30 days, with a median onset of 0 days. Conclusion: Somatrogon's real-world AE pattern shows early-onset injection-site reactions, device-related issues, and endocrine signals, highlighting the need for early treatment monitoring and ongoing post-marketing surveillance as its use grows globally. Key points: This dual-database pharmacovigilance study analyzed somatrogon-associated AE reports from FAERS and VigiAccess, providing a real-world overview of its post-marketing safety profile. Across both databases, the most consistent signal clusters were injection-site reactions, device- and product-related problems, and endocrine/laboratory abnormalities, particularly insulin-like growth factor disturbances. Among FAERS cases with valid onset data, 79.76% of reported events occurred within 30 days, with a median onset of 0 days, indicating that AEs tend to emerge early after treatment initiation. Serious outcomes were relatively uncommon, supporting the importance of early follow-up, injection-site assessment, device-use training, and IGF-1 monitoring in children receiving somatrogon.