Objective  To mine the adverse drug event (ADE) signals of galcanezumab based on U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) to provide reference for clinical drug safety.

Methods  The data from the FAERS database from the third quarter of 2018 to the fourth quarter of 2023 were extracted. After data cleaning and standardization, the duplicate data was removed using structured query language, ADE reports with galcanezumab as the main suspected drug were screened. ADE reports were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities. The reporting odds ratio (ROR) method and information component (IC) method were applied for signal detection.

Results  A total of 60 ADE signals were detected after screening, 11 system organ classes were involved, mainly general disorders and administration site conditions. The ADE signals that occurred most frequently were a variety of discomfort reactions at the injection site, consistent with the most common ADEs documented in the drug insert. The top 3 new ADE signals in order of occurrence frequency were alopecia, weight increased and constipation,  and in order of ROR and IC values were injection site pustule, vertebral artery dissection and Raynaud's phenomenon.

Conclusion  ADE related to galcanezumab mainly involve systemic diseases and various reactions at the site of administration, among which vertebral artery dissection and Raynaud's phenomenon are stronger signals and newer ADEs. The patient’s disease progression should be closely monitored during the treatment period to avoid serious consequences.

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