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 U.S. 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 (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). AEs were assessed at both System Organ Class (SOC) 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.