ArticleNaunyn-Schmiedeberg's archives of pharmacology2026
Post-marketing safety evaluation and objective benefit-risk assessment of sublingual immunotherapy tablets in allergic rhinitis.
Article in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
2 authors.
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Abstract
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.
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