Abstract: A method that detects adverse drug reactions based on machine learning is provided. The method includes receiving raw data including information on adverse events of a plurality of patients with respect to a target drug; classifying the raw data into first data corresponding to adverse reactions of the target drug, second data corresponding to no adverse reactions of the target drug and drugs similar to the target drug, and third data by implementing a database including information about adverse reactions of the target drug and drugs similar to the target drug based on a predetermined standard; learning a machine learning model by implementing a gold standard dataset including data corresponding to the first data and the second data; and determining a possibility of adverse reactions for the prediction dataset including the data corresponding to the third data by implementing the machine learning model.