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<p>GLP-1 receptor agonists are widely used for type 2 diabetes and obesity, making the characterization of their safety profile essential. To describe the main identified and potential risks of semaglutide and liraglutide and summarize the corresponding risk-minimization and pharmacovigilance measures. Evidence from clinical trials, post-marketing data, SmPCs, RMPs, PRAC updates, and real-world studies was reviewed. Relevant safety concerns include worsening of diabetic retinopathy, gastrointestinal intolerance, potential pancreatic and thyroid neoplasms, and emerging signals such as NAION, delayed gastric emptying, neuropsychiatric events, and off-label misuse. Regulatory authorities have implemented routine and additional risk-minimization measures and mandated targeted pharmacovigilance studies. Semaglutide and liraglutide show a favorable and well-characterized safety profile, with most risks manageable through routine monitoring and supported by consistent evidence from clinical trials and real-world data.</p>

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Pharmacovigilance of Semaglutide and Liraglutide: A Narrative Review of Safety Profiles, Emerging Signals, and Risk Management Strategies

  • 期刊论文

  • 发表日期：

    2026年5月13日

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  • Alessia Mihich,
  • Silvia Caranti,
  • Roberto Verna

摘要

GLP-1 receptor agonists are widely used for type 2 diabetes and obesity, making the characterization of their safety profile essential. To describe the main identified and potential risks of semaglutide and liraglutide and summarize the corresponding risk-minimization and pharmacovigilance measures. Evidence from clinical trials, post-marketing data, SmPCs, RMPs, PRAC updates, and real-world studies was reviewed. Relevant safety concerns include worsening of diabetic retinopathy, gastrointestinal intolerance, potential pancreatic and thyroid neoplasms, and emerging signals such as NAION, delayed gastric emptying, neuropsychiatric events, and off-label misuse. Regulatory authorities have implemented routine and additional risk-minimization measures and mandated targeted pharmacovigilance studies. Semaglutide and liraglutide show a favorable and well-characterized safety profile, with most risks manageable through routine monitoring and supported by consistent evidence from clinical trials and real-world data.