Signal mining and analysis of adverse events and pregnancy-related signals of bisoprolol based on the FAERS database

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Author: WANG Dan ^1, ^2, ^3, ⁴  ZHAO Zhenyu ^1, ^2, ^3, ⁴

Affiliation: 1.Department of Pharmacy, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin 300134, China 2.Tianjin Institute of Endocrinology, Tianjin 300134, China 3.NHC Key Laboratory of Hormones and Development, Tianjin 300134, China 4.Tianjin Key Laboratory of Metabolic Diseases, Tianjin 300134, China

Keywords: Bisoprolol FDA Adverse Event Reporting System Proportional imbalance method Signal mining Adverse drug event

DOI: 10.12173/j.issn.2097-4922.202603013

Reference: WANG Dan,ZHAO Zhenyu. Signal mining and analysis of adverse events and pregnancy-related signals of bisoprolol based on the FAERS database[J]. Frontiers in Pharmaceutical Sciences,2026,30(10):1739-1750. DOI:10.12173/j.issn.2097-4922.202603013[Article in Chinese]  Copied

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Abstract

Objective To identify and analyze adverse drug event (ADE) signals associated with bisoprolol based on the FDA Adverse Event Reporting System (FAERS), and to provide a basis for safe medication in clinical practice.

Methods ADE reports of bisoprolol from Q1 2004 to Q1 2025 were extracted from the FAERS database. Signal mining and analysis were performed using the reporting odds ratio (ROR) method, the proportional reporting ratio (PRR) method, and the Bayesian confidence propagation neural network (BCPNN) method.

Results A total of 9,748 reports related to bisoprolol were obtained, and 672 positive signals were detected, involving 25 system organ classes (SOCs); ADEs with high reporting frequencies included bradycardia, dyspnea, hypotension, dizziness, and falls; ADEs with strong signals included bradyarrhythmia, bradycardia, sinus bradycardia, and complete atrioventricular block. Notably, potential association signals such as acute kidney injury and retroperitoneal fibrosis were also identified. In addition, 41 positive signals related to drug exposure during pregnancy were observed, including small for gestational age infant, fetal growth restriction, neonatal hypoglycemia, and neonatal respiratory depression.

Conclusions Close monitoring of adverse reactions is warranted in clinical use of bisoprolol; individualized assessment of concomitant medication risks and vigilance for potential off-label risks are warranted. For pregnant patients, alternative treatment options should be evaluated in advance; if bisoprolol administration is unavoidable, monitoring of fetal growth and neonatal vital signs should be strengthened.

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