Immunosuppressant or Biologic Medications May Increase Risk for Skin Cancer

These study findings are of particular importance to patients with psoriasis, who may receive long-term treatment with immunosuppressant and biologic medications.

Several oral immunosuppressants and biologic medications are associated with an increased risk for skin cancers, according to study findings published in Dermatology.

A researcher at the University of Arizona College of Medicine-Tucson sourced data from the Food and Drug Administration Adverse Event Reporting System. This case-controlled analysis evaluated data of immunosuppressant and biologic medication use between 1968 and 2021.

The total number of adverse events reported in the study period was 23,210,374. Of all events, there were 11,651 melanomas, 11,040 basal cell carcinomas (BCCs), 3931 squamous cell carcinomas (SCCs), and 609 melanoma and Merkel cell carcinomas (MCCs).

The skin cancer type with the greatest number of medications associated with increased risk was BCC, with 26 risk-associated drugs. The greatest risk was associated with azathioprine (reporting odds ratio [ROR], 23.15), followed by infliximab (ROR, 20.65), hydroxychloroquine (ROR, 18.85), ustekinumab (ROR, 12.95), and rituximab (ROR, 12.92).

[D]ermatologists should consider close follow-up in patients on immunosuppressants and biologics who may be at increased risk of developing skin cancer.

Risk for melanoma was associated with use of 23 medications, specifically guselkumab (ROR, 12.73), azathioprine (ROR, 8.72), infliximab (ROR, 8.02), acitretin (ROR, 7.08), and sirolimus (ROR, 6.68).

Overall, 19 medications were associated with increased risk for SCC. In ranked order, the greatest risk was associated with voriconazole (ROR, 78.48), followed by azathioprine (ROR, 34.13), tacrolimus (ROR, 19.27), mycophenolate (ROR, 18.01), and cyclosporine (ROR, 14.54).

Risk for MCC was associated with the fewest number of medications (n=17). The greatest risk was observed with azathioprine (ROR, 44.76), sirolimus (ROR, 38.60), voriconazole (ROR, 28.40), ruxolitinib (ROR, 26.37), and cyclosporine (ROR, 19.63).

This study was limited by its retrospective design and may have included reporting bias.

The study author concluded, “[M]any immunosuppressant and biologic systemic medications commonly prescribed in dermatology are associated with an increased ROR of skin cancer. […] Accordingly, dermatologists should consider close follow-up in patients on immunosuppressants and biologics who may be at increased risk of developing skin cancer.”


Jedlowski PM. Association of non-melanoma skin cancers, melanoma and merkel cell carcinoma with dermatologic medications, a case control pharmacovigilance study of the FDA Adverse Events Reporting System. Dermatology. Published online April 13, 2023. doi:10.1159/000530107