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September 10, 2025

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases

Key Points

Significant over-reporting signals for SCARs were observed in apalutamide users, indicating a risk.
The lethal rates of apalutamide-related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS.
A retrospective pharmacovigilance analysis using FAERS, EudraVigilance, and JADER databases was conducted.
This study emphasizes the need for practitioners to be aware of apalutamide-SCARs risks due to its increasing use.

Abstract

Abstract Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025 = 4.12, IC 025 = 1.70, N = 30; EudraVigilance, ROR 025 = 11.54, IC 025 = 2.84, N = 55; JADER, ROR 025 = 2.90, IC 025 = 1.33, N = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N = 29, EudraVigilance, ROR 025 = 30.96, IC 025 = 3.74, N = 58; JADER, ROR 025 = 5.34, IC 025 = 1.85, N = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N = 38; EudraVigilance, ROR 025 = 25.06, IC 025 = 3.53, N = 55; JADER, ROR 025 = 0.62, IC 025 = 0.19, N = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N = 7; EudraVigilance, ROR 025 = 4.18, IC 025 = 1.02, N = 5; JADER, ROR 025 = 1.05, IC 025 = 0.45, N = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

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