Real-world pharmacovigilance assessment of drug-induced male hypogonadism risks: An analysis of FDA adverse drug event data.

Abstract

Background: Drug-induced hypogonadism is an underrecognized but significant adverse effect of various medications, contributing to male sexual dysfunction and infertility. Despite its clinical significance, comprehensive studies systematically identifying high-risk drugs remain limited.

Objectives: This study aimed to investigate the potential drugs associated with hypogonadism from FDA Adverse Event Reporting System.

Materials and methods: This study analyzed adverse drug events reported from FDA Adverse Event Reporting System covering the period from the first quarter of 2004 to the third quarter of 2024. Cases related to hypogonadism were identified using standardized Medical Dictionary for Regulatory Activities preferred terms. Disproportionality analyses were conducted using the reporting odds ratio and the Bayesian confidence propagation neural network. Drugs were classified according to Anatomical Therapeutic Chemical classification system and clinical applications. This study utilized FDA Label to determine whether adverse drug events related to male hypogonadism are mentioned on their labels.

Results: We identified 10 classes including 42 drugs that showed positive signals for both reporting odds ratio and Bayesian confidence propagation neural network: anesthetics and analgesics, psychiatric and neurological medications, antineoplastic agents, urological medications, hormonal agents, cardiovascular medications, gastrointestinal medications, bone metabolism modifiers, antiretroviral agents, and other drugs. According to the Bayesian confidence propagation neural network algorithm, 6 drugs were considered to have a high risk of causing hypogonadism, and 11 drugs had medium risk. In addition, 20 drugs did not mention adverse drug events related to male hypogonadism, of which 3 were identified as high risk using the Bayesian confidence propagation neural network algorithm.

Conclusions: This research summarized a list of potential drugs associated with hypogonadism. A clear understanding of the risk and frequency of drug-induced hypogonadism can reduce the likelihood of patients developing the condition.