Adverse event profiles of drug-induced decreased libido: an assessment of the US food and drug administration Adverse Event Reporting System

Abstract

Background: Drug-induced decreased libido significantly affects the quality of life and relationships of patients. However, no comprehensive study has examined the relationship between drugs and libido. This study assessed drug-induced decreased libido by mining data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Research design and methods: Adverse drug event (ADE) reports from the first quarter of 2004 to the fourth quarter of 2023 in FAERS were collected and screened for reports of decreased libido and were subjected to medication signal mining by using the disproportionality analysis.

Results: Overall 10,773 ADE reports were obtained. Thirty-three of the top 50 drugs with the highest frequency of ADE reports did not mention the risk of reduced libido in their instructions. Fifty-eight drugs showed potential decreased libido risk based on the disproportionality analysis, with 40 of the drugs not mentioning the risk of reduced libido in their instructions. Of these 40 drugs, drugs used in genito urinary and sex hormones and nervous system were the drug class with the greatest number of ADE reports.

Conclusion: A data mining exercise using FAERS for drugs that cause decreased libido has identified 40 drugs with new signals of adverse effects that should be closely monitored in medical practice.

Keywords: Decreased libido; FAERS; FDA; Pharmacovigilance; data mining.