Objective  To evaluate the cancer risk associated with fingolimod for the treatment of multiple sclerosis (MS).

Methods  Data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the fourth quarter of 2022 were extracted. The reporting odds ratio (ROR) method and information components (IC) method were used to identify the association between fingolimod and potential cancer event reports in multiple sclerosis patients.

Results  A total of 1 628 reports related to fingolimod in the treatment of multiple sclerosis were identified. Skin and mucous membrane cancer (527 items), breast cancer (89 items), and female genital cancer (43 items) were the top three cancers category in terms of report. The analysis showed that basal cell carcinoma (189 items, ROR=5.67, ROR₀₂₅=4.91, IC₀₂₅=2.23), malignant melanoma (105 items, ROR=3.29, ROR₀₂₅=2.71, IC₀₂₅=1.39), squamous cell carcinoma (62 items, ROR=2.91, ROR₀₂₅=2.27, IC₀₂₅=1.12), invasive ductal breast carcinoma (53 items, ROR=8.62, ROR₀₂₅=6.56, IC₀₂₅=2.46), cutaneous squamous cell carcinoma (45 items, ROR=3.58, ROR₀₂₅=2.67, IC₀₂₅=1.31) and cervix carcinoma (37 items, ROR=4.09, ROR₀₂₅=2.96, IC₀₂₅=1.41) were the top six cancer events in terms of report.

Conclusion  Fingolimod is associated with a much broader scope of potential cancer events in multiple sclerosis patients. Further clinical studies are required to explore a better understanding of this phenomenon, and dermatological follow-up is recommended for patients taking fingolimod.

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