Mining of Respiratory System Toxicity Risk Signals for Fulvestrant Based on the Tianjin Adverse Reaction Monitoring Center and the FDA Adverse Event Reporting System Database

Abstract

Background:

We sought to mine the respiratory system toxicity risk signals associated with fulvestrant, with the aim to enhance clinical awareness of its respiratory toxicity.

Research design and methods:

The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed to mine respiratory system toxicity risk signals of fulvestrant from the Tianjin Adverse Drug Reaction Monitoring Center (Tianjin Center) database and the FDA Adverse Event Reporting System (FAERS) database between January 2004 and July 2025. The mined risk signals were statistically classified and described using the Medical Dictionary for Regulatory Activities (23.1 edition).

Results:

The Tianjin Center database contained 233 adverse drug event (ADE) reports in which fulvestrant was the primary suspected drug, with 156 reports involving respiratory, thoracic, and mediastinal disorders. Cough was the most frequently reported ADE, with the strongest signals detected for throat irritation, throat tightness, and cough. The FAERS database contained 12 364 ADE reports with fulvestrant as the primary suspected drug, with 818 reports involving respiratory, thoracic, and mediastinal disorders. Cough was the most frequently reported ADE, with the strongest signals detected for mediastinal fibrosis, pulmonary septal thickening, and pleural thickening.

Conclusions:

Clinical use of fulvestrant should include careful monitoring for respiratory adverse events.