Objective  To provide a reference for clinical administration of amiodarone by mining the amiodarone-related adverse events（ADEs）signals of respiratory system based on the U.S. Food and Drug Administration Adverse Event Reporting System（FAERS）.

Methods Reporting odds ratio（ROR）method and the proportional reporting ratio（PRR ）method were used to mine the amiodarone-related ADEs signals of respiratory system based on the adverse event report data of 24 quarters from the first quarter of 2016 to the fourth quarter of 2021 extracted from the FAERS database. After valid signals were obtained, the Medical Dictionary for Regularly Activities（MedDRA）was used for translation and system organ classification.

Results  Totally 39 166 amiodarone-related reports were obtained, 6 903 ADEs of respiratory system were reported. There were 71 preferred terms（PT）with signal, which could be divided into 8 high level group term（HLGT）, among which the HLGT of respiratory diseases signal number 25 and 3 199 ADE reports accounted for the most. The top 5 reported PT were dyspnea, pulmonary fibrosis, cough, pulmonary toxicity and interstitial lung disease. The top 5 PT with the highest signal intensity were pulmonary toxicity, pulmonary fibrosis, mediastinal hemorrhage, organising pneumonia and diaphragmatic paralysis. Respiratory failure, wheezing, and acute respiratory distress syndrome（ARDS）were the top three proportions of causes of death. There were 29 PT that were not included in the drug instructions, among which chest diseases such as mediastinal hemorrhage, diaphragmatic paralysis and mediastinal hematoma were not frequent, but strongly correlated with amiodarone.

Conclusions  Attention should be paid to the risk of amiodarone-related ADEs of respiratory system, especially the lung toxicity and acute respiratory disease, focusing on special groups the elderly, children and these may be high risk factors for male and the aged, we should strengthen medical assessment of lung function before and after medication, medication in monitoring, timely diagnosis and treatment, prevent amiodarone the occurrence of ADEs related to respiratory system.

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