Analysis: No Lymphoma Signal With Topical Calcineurin Inhibitors

A recent pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database found no significant association between topical calcineurin inhibitors (TCIs) and lymphoma, despite longstanding boxed warnings in the United States.

The investigator on the study conducted a case-controlled analysis of FAERS reports from January 2014 through March 2025, encompassing more than 56 million adverse drug reactions from over 17 million deduplicated cases. Eleven therapies for atopic dermatitis (AD) were evaluated using reporting odds ratio (ROR) and Empirical Bayesian Geometric Mean (EBGM) methods to detect safety signals for lymphoma. Results were published in a research in JAAD International. 

ROR analysis showed significant lymphoma signals across several therapies, although the authors noted that ROR may overestimate risk for rare adverse events. EBGM did not demonstrate significant lymphoma signals for topical tacrolimus or pimecrolimus. Tacrolimus lost statistical significance when analyses were restricted to AD indications.

“Analysis of real-world aggregate data suggests that TCI such as tacrolimus and pimecrolimus are not associated with any significant lymphoma safety signals following tabulation of the EBGM,” the authors wrote. “This study may help provide reassurance to concerned clinicians in light of related mounting evidence supporting TCI safety.”

Source: Arcuri D. JAAD International. 2026. Doi:10.1016/j.jdin.2026.01.002