Abstract: Objective s To analyze the signals of adverse drug events (ADE) induced by alirocumab in the real world based on openFDA in order to provide reference for clinical rational use of the drug. Methods All the data on ADE was retrieved from the openFDA database collected between January 1, 2004 and May 7, 2020. ADE signals were detected by ROR and MHRA. Results Totally, 15 511 cases and 56 912 combinations of alirocumab were reported. Most of the reporters were consumers or non-health care providers, accounting for 71.10%. Reports from the United States accounted for 95.82%. After screening, 163 positive signals of alirocumab were obtained. ADE were mainly manifested as systemic disorders, responses at the sites of administration, musculoskeletal and connective tissue disorders, injury, poisoning, complications, and respiratory, thoracic and mediastinal disorders. Common ADE occurred in the nasopharynx and at the sites of injection. Conclusion The ADE signals of alirocumab involve 20 SOCs. Special attention should be paid to female or elderly patients or those with underlying heart diseases.

Key words: openFDA, alirocumab, Praluent, adverse drug events, data mining