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<p>To evaluate the post-marketing safety profile and benefit-risk balance of FDA-approved sublingual immunotherapy (SLIT) tablets for allergic rhinitis. A retrospective pharmacovigilance analysis was conducted using FAERS data (2014–2025). Reports including Oralair®, Grazax®/Grastek®, Ragwitek®, and Odactra® as suspected drugs were analyzed descriptively. A total of 1509 cases were identified, mostly in adults. Most adverse events (59.17%) were non-serious. The most common reactions were throat irritation, oral pruritus, dyspnoea, pruritus, and throat tightness. Serious outcomes were uncommon, including hospitalization (7.45%), life-threatening events (3.12%), and death (0.25%). The safety profile was consistent with clinical trial data. SLIT tablets demonstrate a favorable safety profile with a positive benefit-risk balance. They represent an effective and generally safe option for allergic rhinitis when appropriate patient selection and clinical monitoring are ensured.</p>

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Post-marketing safety evaluation and objective benefit-risk assessment of sublingual immunotherapy tablets in allergic rhinitis

  • 期刊论文

  • 发表日期：

    2026年4月8日

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  • Eleonora Castellana,
  • Maria Rachele Chiappetta

摘要

To evaluate the post-marketing safety profile and benefit-risk balance of FDA-approved sublingual immunotherapy (SLIT) tablets for allergic rhinitis. A retrospective pharmacovigilance analysis was conducted using FAERS data (2014–2025). Reports including Oralair®, Grazax®/Grastek®, Ragwitek®, and Odactra® as suspected drugs were analyzed descriptively. A total of 1509 cases were identified, mostly in adults. Most adverse events (59.17%) were non-serious. The most common reactions were throat irritation, oral pruritus, dyspnoea, pruritus, and throat tightness. Serious outcomes were uncommon, including hospitalization (7.45%), life-threatening events (3.12%), and death (0.25%). The safety profile was consistent with clinical trial data. SLIT tablets demonstrate a favorable safety profile with a positive benefit-risk balance. They represent an effective and generally safe option for allergic rhinitis when appropriate patient selection and clinical monitoring are ensured.