A review of the safety of oral immunotherapy in clinical trial and real-world studies.

Safety concerns are a barrier to oral immunotherapy (OIT). This review aims to describe OIT safety events and explore potential risk factors and mitigating factors. Published clinical and real-world OIT studies were reviewed for data on safety outcomes in OIT. Gastrointestinal symptoms are one of the most common adverse reactions associated with OIT, and persistent symptoms can be associated with an eosinophilic response. Allergic reactions are increased in OIT compared with avoidance; however, these symptoms tend not to be severe and to decrease over time. Despite OIT, epinephrine usage persists in studies and life-threatening reactions (though rare) have occurred. High baseline food specific immunoglobulin E levels, aggressive dosing, uncontrolled atopic comorbidities, and poor adherence to protocols may contribute to the severity of adverse events. OIT remains a shared decision that incorporates best medical evidence and appropriate patient selection. It requires individualized care and action plans to ensure safe outcomes.