Survey of Drugs Induced Skin Pigmentation (Hyper and Hypo Pigmentation).

BACKGROUND

Drug-induced skin pigmentary changes are an underrecognized yet clinically significant type of adverse event (AE). Despite growing awareness, labeling for many implicated drugs remains incomplete.

OBJECTIVE

To conduct a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database (2010-2024) to identify drugs associated with skin hyperpigmentation, hypopigmentation, or both, and to explore their clinical implications and repurposing potential.

METHODS

The study analyzed case reports from the FAERS database using the OpenVigil 2.1 platform. Pigmentary AEs were identified based on the MedDRA Preferred Terms "skin hyperpigmentation" and "skin hypopigmentation." To ensure consistency, all drug names were standardized to their generic forms using the DrugBank database before inclusion in the analysis. Disproportionality analysis was performed using the Reporting Odds Ratio (ROR) to detect significant associations between drugs and pigmentary AEs.

RESULTS

A spectrum of agents demonstrated strong associations with pigmentary changes. Minocycline (ROR 115.66) and setmelanotide (ROR 1506.82) showed high RORs for hyperpigmentation, while triamcinolone (ROR 37.20) and ribociclib (ROR 60.20) were strongly linked to hypopigmentation. Several drugs, including dupilumab, tretinoin, and clobetasol, exhibited bidirectional pigmentary modulation. Notably, a substantial proportion of implicated drugs lacked labeling for these effects.

CONCLUSION

This study identifies notable pigmentary AE signals associated with several commonly prescribed drugs. These findings emphasize the importance of early recognition and dermatologic monitoring during prolonged therapy. Considering the odds ratio and analysis results, the drugs found to be associated with hyperpigmentation or hypopigmentation warrant further investigation.