Disproportionality analyses of Tapinarof-related adverse events based on the FAERS database.
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BACKGROUND: Tapinarof, a novel topical aryl hydrocarbon receptor (AhR) modulator, has demonstrated promising therapeutic efficacy in the treatment of plaque psoriasis. However, its comprehensive safety profile in real-world settings remains underexplored. OBJECTIVE: To assess the post-marketing safety of Tapinarof using data from the FDA Adverse Event Reporting System (FAERS), with a focus on identifying significant adverse event (AE) signals and subgroup-specific risks. METHODS: A retrospective disproportionality analysis was conducted on FAERS data from Q2 2022 to Q4 2024. Reports listing Tapinarof as the primary suspect drug were extracted and analyzed using four established signal detection algorithms (ROR, PRR, EBGM, IC), complemented by Bonferroni correction for multiple comparisons. RESULTS: A total of 1,227 AE reports were included. The majority of reports originated from adults aged 18-64 years and were submitted by healthcare professionals, with a balanced male-to-female ratio. The most frequently observed AE signals were related to skin and subcutaneous tissue disorders, including keratosis pilaris, contact dermatitis, and application site acne. Notable signals were also detected for infections (e.g., pustules) and hypersensitivity reactions. A novel tumor-related signal was identified for keratoacanthoma, with statistically significant associations also observed for squamous cell carcinoma of the skin. Gender subgroup analysis revealed a higher incidence of dermatological AEs in females and slightly stronger neoplasm-related signals in males. Age, weight, and indication data were largely missing, limiting subgroup-specific interpretation. CONCLUSION: Tapinarof is generally well tolerated in adults, particularly for psoriasis treatment, but is associated with strong cutaneous and immune-related AE signals. Novel findings-including pharyngeal swelling and tumor-related events-warrant heightened clinical vigilance, especially in patients requiring long-term or large-area application. Gender differences in AE reporting further underscore the need for personalized risk management strategies. Further longitudinal and mechanistic studies are essential to confirm these associations and guide safer clinical use.