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Background <p>Despite decades of clinical use, comprehensive real-world data on adverse events (AEs) associated with growth hormone (GH) remain scarce. To bridge this gap, we analyzed GH-related AEs signals in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p> Methods <p>We extracted data from the FAERS database spanning the first quarter (Q1) of 2004 through the fourth quarter (Q4) of 2024. Drug names and AEs were standardized, and then we performed disproportionality analyses using four distinct algorithms to detect potential safety signals associated with GH. Sensitivity analyses were performed to account for potential confounding factors and validate the robustness of our findings.</p> Results <p>In this study, 18,082,548 case reports were collected from the FAERS database, of which 62,861 AEs related to GH were reported. After categorization, we identified 24 system organ classes(SOCs), only injury, poisoning and procedural complications, and endocrine disorders both satisfied the four algorithms. At the preferred term (PT) level, we identified 555 PTs that showed significant disproportionality in all four algorithms. Adipomastia, craniopharyngioma, non-secretory adenoma of pituitary, acral overgrowth, and insulin-like growth factor decreased were the most prominent PTs. Several previously underreported signals were identified, including haemoglobin distribution width decreased, septo-optic dysplasia, and blood growth hormone decreased. Sensitivity analysis excluding device-related events revealed that the signal strength of pharmacological AEs was substantially strengthened.</p> Conclusion <p>Most of our results were consistent with the drug label, but several signals were not documented in the current product information. Patients and healthcare providers should remain vigilant about these AEs. We also need further studies to validate these unlabeled AEs and to provide essential support for clinical monitoring and risk identification of GH.</p>

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Adverse Events Associated with Growth Hormone Therapy: A Pharmacovigilance Study

  • 期刊论文

  • 发表日期：

    2026年4月27日

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  • Xie Zhanfang,
  • Hu Yan,
  • Wang Yanhong,
  • Luo Liujin,
  • Li Ganggang,
  • Zhou Jing

摘要

Background

Despite decades of clinical use, comprehensive real-world data on adverse events (AEs) associated with growth hormone (GH) remain scarce. To bridge this gap, we analyzed GH-related AEs signals in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

We extracted data from the FAERS database spanning the first quarter (Q1) of 2004 through the fourth quarter (Q4) of 2024. Drug names and AEs were standardized, and then we performed disproportionality analyses using four distinct algorithms to detect potential safety signals associated with GH. Sensitivity analyses were performed to account for potential confounding factors and validate the robustness of our findings.

Results

In this study, 18,082,548 case reports were collected from the FAERS database, of which 62,861 AEs related to GH were reported. After categorization, we identified 24 system organ classes(SOCs), only injury, poisoning and procedural complications, and endocrine disorders both satisfied the four algorithms. At the preferred term (PT) level, we identified 555 PTs that showed significant disproportionality in all four algorithms. Adipomastia, craniopharyngioma, non-secretory adenoma of pituitary, acral overgrowth, and insulin-like growth factor decreased were the most prominent PTs. Several previously underreported signals were identified, including haemoglobin distribution width decreased, septo-optic dysplasia, and blood growth hormone decreased. Sensitivity analysis excluding device-related events revealed that the signal strength of pharmacological AEs was substantially strengthened.

Conclusion

Most of our results were consistent with the drug label, but several signals were not documented in the current product information. Patients and healthcare providers should remain vigilant about these AEs. We also need further studies to validate these unlabeled AEs and to provide essential support for clinical monitoring and risk identification of GH.