A real-world FAERS analysis identified 4,326 adverse event reports associated with alglucosidase alfa in Pompe disease, including both known complications and signals not previously prominent in routine labeling. The study used FDA’s Adverse Event Reporting System to characterize reporting patterns and quantify the scale of safety events tied to the therapy. The findings matter for pharmacovigilance teams and clinicians managing long-term enzyme replacement therapy, as real-world datasets can reveal rare patterns that controlled trials may under-detect due to smaller sample sizes and limited observation windows. The analysis also highlights the continued role of post-market surveillance in refining risk management plans and informing monitoring practices for patients receiving rare-disease biologics.