Objective  To mine adverse drug events (ADEs) signals associated with lanadelumab, and to provide reference evidence for clinical medication safety.

Methods  ADE reports listing lanadelumab as the primary suspected drug were retrospectively retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from the third quarter of 2018 to the first quarter of 2025. Signal detection was performed using a combination of reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method. ADE distributions and signal strengths were analyzed at both the system organ class (SOC) and preferred term (PT) levels.

Results  A total of 2,533 reports involving 11,536 ADEs were identified with lanadelumab as the primary suspected drug. Reports predominantly involved female patients (69.72%) and individuals aged 18 to under 65 years (46.51%), with 87.80% of reports originating from the United States. A total of 70 ADE signals were identified, affecting 18 SOCs, primarily involving investigations, general disorders and administration site conditions, and nervous system disorders. The top 3 ADEs in terms of report numbers were weight loss, weight gain, and injection site pain. The ADE with the highest signal strength was injection-site bruising. Additionally, several previously unlisted potential ADE signals were identified, including cutaneous lupus erythematosus, jugular vein thrombosis, seizures, nasopharyngitis, and stress.

Conclusion  Lanadelumab associated ADEs involve multiple organ systems, and the common ADE signals of lanadelumab are consistent with the instructions. However clinicians should also be alert to the ADEs not recorded in the instruction such as weight fluctuation and thrombosis.

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