Vigilance for drug safety of darolutamide in the cancer therapies: a disproportionality analysis from the FDA Adverse Event Reporting System

Zhenquan Wu; Yiming Liang; Shouying Li; Jiewen Chen

doi:10.1007/s00210-026-05253-5

Vigilance for drug safety of darolutamide in the cancer therapies: a disproportionality analysis from the FDA Adverse Event Reporting System

Naunyn Schmiedebergs Arch Pharmacol. 2026 Mar 26. doi: 10.1007/s00210-026-05253-5. Online ahead of print.

Authors

Zhenquan Wu^#¹, Yiming Liang^#², Shouying Li³, Jiewen Chen⁴

Affiliations

¹ Department of Urology, the First People's Hospital of Foshan, the Affiliated Foshan Hospital, Southern University of Science and Technology, Foshan, 528000, Guangdong, China.
² Xiangya School of Medicine, Central South University, Changsha, 410000, Hunan, China.
³ Department of Urology, the Affiliated Foshan Women and Children Hospital, Guangdong Medical University, Foshan, 528000, Guangdong, China.
⁴ Department of Breast Medicine, the Affiliated Foshan Women and Children Hospital, Guangdong Medical University, Foshan, 528000, Guangdong, China. jiewenchen1111@126.com.

^# Contributed equally.

PMID: 41886076
DOI: 10.1007/s00210-026-05253-5

Abstract

The purpose of this study is to provide a more granular post-marketing safety assessment of darolutamide, a novel oral non-steroidal androgen receptor antagonist. We assessed safety signals associated with adverse events (AEs) using disproportionality analysis within the FDA Adverse Event Reporting System (FAERS) database at both the system organ class (SOC) and preferred term (PT) levels, followed by age-stratified subgroup analyses and time-to-onset analysis. This study identified 11 positive AE signals at the SOC level and 62 positive signals at the PT level. Several unexpected nervous system disorders were detected, including peripheral neuropathy (ROR [95% CI] = 10.56 [8.62-12.93]), brain fog (ROR [95% CI] = 4.16 [1.98-8.74]), difficulty in standing (ROR [95% CI] = 4.15 [2.23-7.72]), ageusia (ROR [95% CI] = 3.83 [1.91-7.67]), and hypoesthesia (ROR [95% CI] = 2.98 [2.14-4.16]), which were not listed on the drug label. Age-specific AEs were observed, such as erectile dysfunction in patients aged 18-64 years and multiple fractures in patients aged over 65 years. The median time to onset of AEs was 30 days. This study identifies AEs reported in association with darolutamide, which may aid clinical surveillance and risk assessment of this medication.

Keywords: Adverse events; Darolutamide; Disproportionality analysis; FAERS.