Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System.

BACKGROUND

Clascoterone is a novel drug for the treatment of acne vulgaris (AV). To gain an improved comprehension of clascoterone safety in the real world, we conducted a disproportionality analysis based on data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

METHODS

Methods Data enrolled in this study was from the FAERS database, covering the period from Q3 2020 to Q4 2024. The risk signals of clascoterone were mined through four disproportional algorithms (reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS)). The time-to-onset (TTO) analysis of risk signals was conducted.

RESULTS

Among 1085 clascoterone-associated adverse events (AEs), five system organ classes met ROR/BCPNN positive thresholds: product issues (ROR = 16.21, 95%CI(Confidence interval) = 14.68-17.89), injury, poisoning and procedural complications (ROR = 5.69, 95%CI 5.23-6.2), surgical and medical procedures (ROR = 2.97, 95%CI 2.41-3.65), reproductive system and breast disorders (ROR = 1.88, 95%CI 1.25-2.83), and skin and subcutaneous tissue disorders (ROR = 1.83, 95%CI 1.58-2.12). At the preferred term (PT) level, 45 positive signals were detected, including some common AEs (erythema and dry skin) and some uncommon AEs with strong strength (such as hypothalamic pituitary adrenal axis suppression, skin striae, and hair growth abnormal). Furthermore, TTO analysis revealed that over 70% of AEs happened within the first month following therapy.

CONCLUSION

Our study provides broader data support for the safety of clascoterone and offers important insights to enhance the clinical use and minimize potential adverse effects.