Objective To evaluate the association strength, clinical characteristics and demographic features of adverse drug events (ADE) of minocycline-induced pigmentation based on the Adverse Event Reporting System database of the US Food and Drug Administration (FAERS).

Methods Reports of minocycline-related pigmentation ADEs in the FAERS database from January 2004 to June 2025 were retrieved via the OpenVigil 2.1 platform. Signal mining was conducted using the reporting odds ratio (ROR) method, and univariate Logistic regression analysis was used to analyze the correlation between pigmentation-related preferred terms (PT) with age and gender.

Results A total of 500 reports of minocycline-related pigmentation ADEs were included. The proportion of patients over 45 years old was 61.60%, and the gender distribution was balanced. According to the system organ class (SOC), the pigmentation-related PT mainly involved five systems: skin and subcutaneous tissue disorders (58.90%), eye disorders (17.66%), gastrointestinal disorders (11.29%), musculoskeletal and connective tissue disorders (8.83%), and general disorders and administration site conditions (3.33%). The PT with the strongest signal intensity was bone pigmentation (ROR =24 105.559, 95%CI: 11 528.410-50 403.992), followed by conjunctival pigmentation (ROR = 7 433.703, 95%CI: 3 252.440-16 990.303), and the PT with the weakest signal intensity was tongue discoloration (ROR =9.493, 95%CI: 4.518-19.948). Bone pigmentation, tooth discoloration, scleral depigmentation, skin pigmentation and scleral pigmentation were correlated with age (P <0.05); bone pigmentation, skin discoloration, conjunctival pigmentation and tooth discoloration were correlated with gender (P <0.05).

Conclusion Minocycline-related pigmentation is related to age and gender. During the medication period of elderly patients, the risk of pigmentation in the sclera and skin needs to be closely monitored.

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