Adverse Drug Reactions of Elagolix Based on the FAERS Database

doi:10.19803/j.1672-8629.20240999

Abstract

Abstract: Objective To mine signals of adverse drug reactions induced by elagolix and provide references for safe and rational use of drugs in patients with endometriosis. Methods Data on all the adverse drug events (ADEs) of elagolix was retrieved from the U.S. Food and Drug Administration Adverse Event Reporting System database from July 23, 2018 to September 30, 2024, and reports in which elagolix was listed as the “primary suspect” (PS) were obtained. Data was analyzed using the reporting odds ratio (ROR)method, proportional reporting ratio (PRR) method, Bayesian Confidence Propagation Neural Network (BCPNN) method, and the Multiple Gamma-Poisson Shrinkage Estimation (MGPS) method. Results A total of 10 005 reports of ADEs related to elagolix were identified, involving 3 775 patients, 27 System Organ Classes (SOCs) and 145 preferred terms (PTs). Positive SOCs that met all the four algorithms were surgical and treatment procedures, the reproductive system, breast diseases, psychiatric disorders, and vascular and lymphatic diseases. The most frequent PTs were hot flashes, ache, and nausea headache. New ADEs that were never mentioned in drug inserts were discovered, such as alopecia, food craving, umbilical haemorrhage. Conclusion When elagolix is used to treat endometriosis, clinicians need to be alert to adverse events in patients, identify risks as early as possible, and ensure the rational use of drugs in clinical practice.

Key words: Elagolix, Endometriosis, Adverse Events, Alopecia, Food Craving, Food and Drug Administration Adverse Event Reporting System Database（FAERS), Signal Mining, Pharmacovigilance

CLC Number:

R984
R994.11

LI Ruohan, HU Panwei, YANG Hong, QIAN Lin. Adverse Drug Reactions of Elagolix Based on the FAERS Database[J]. Chinese Journal of Pharmacovigilance, 2025, 22(11): 1287-1291.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I11/1287

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