Effects of a single oral administration of finasteride tablets on bilirubin levels

doi:10.19803/j.1672-8629.20210275

Abstract

Abstract: Objective To study the safety and adverse events of finasteride in healthy Chinese subjects and to provide reference for rational use of drugs. Methods A total of 103 healthy Chinese male volunteers were enrolled in fasting and fed states in two randomized, crossover, two-period, bioequivalence studies of the test preparation of single oral 5 mg finasteride. All laboratory parameters, vital signs, and adverse events were monitored and recorded throughout the study. Results In both trials, finasteride was well tolerated and no serious adverse events were reported. Among the adverse events that were observed, the elevation of bilirubin levels was the most frequent in each trial, and resolved within 10 days. Conclusion Finasteride is a potent and selective UGT1A4-competitive inhibitor that is critical to the metabolism of bilirubin. Finasteride may cause bilirubin elevation. It is recommended that clinicians pay attention to the risk of bilirubin elevation associated with finasteride in clinical use.

Key words: finasteride, bilirubin elevation, bioequivalence study, safety, adverse drug reaction, adverse event

CLC Number:

R977
R994.11

LI Lingjun, TAO Lei, WEI Jun, LI Hongyang, CAI Baole, MA Pengcheng. Effects of a single oral administration of finasteride tablets on bilirubin levels[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1202-1205.

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