Infusion Reaction

Infusion Reaction describes an adverse response occurring during or shortly after administration of a drug delivered intravenously, commonly associated with biologics including monoclonal antibodies, enzyme replacement therapies, and certain cell-based products. These reactions range from mild symptoms such as fever, chills, flushing, rash, or nausea to severe events including hypotension, bronchospasm, angioedema, or anaphylaxis.

The biopharmaceutical industry monitors infusion reactions closely during clinical development and post-marketing use due to their safety implications and impact on treatment adherence. Clinical protocols often include premedication strategies such as antihistamines, corticosteroids, or antipyretics to reduce reaction risk. Infusion rates may be adjusted, slowed, or interrupted based on symptom severity, with emergency management procedures established at treatment sites. Distinguishing infusion reactions from true IgE-mediated allergic reactions is important for future dosing decisions. Product labelling includes guidance on monitoring, prevention, and management. As biologics expand across therapeutic areas, infusion reaction management remains a key component of clinical safety oversight.