Abstract: Objective To analyze the adverse drug reaction (ADR) signals of statins and to provide a reference for rational clinical use of drugs. Methods The ADR reports of seven statins received by the Database of Chengdu Institute for Drug Control in 2011-2024 were collected. The reporting odds ratio (ROR) method was used to analyze patients' basic information, system organ classes involved, and detection results of ADR signals. Results A total of 1223 ADR reports with statins as suspected drugs were retrieved, involving more male patients than female ones, and most of the patients range from 56 to 70 in age. These reports involved 18 system organ classes, including diseases of the hepatobiliary system, diseases of the gastrointestinal system, diseases of the skin and subcutaneous tissue, musculoskeletal and connective tissue diseases, andneurological diseases. Twenty-one ADR signals were identified for atorvastatin, manifested in elevated blood creatinekinase (CK), rhabdomyolysis, increased blood myoglobin, myalgia and increased transaminase. Six ADR signals were mined for rosuvastatin, manifested in elevated blood CK and transaminase, myalgia. Twelve ADR signals were detected for simvastatin, manifested in rhabdomyolysis, elevated blood CK, hair loss, liver injury and myalgia and one ADR signal was identified for pravastatin, manifested in abnormal liver function. ADR signals were not detected for fluvastatin, lovastatin or pitavastatin due to the small number of collected reports. ADR signals common to most of the statins were abnormal liver function, elevated blood CK, myalgia and abdominal discomfort. Conclusion Statins can generate ADR signals with strong correlation strength in both the hepatobiliary and muscular systems, so clinicians should be alert to severe ADRs such as rhabdomyolysis and liver injury. A suspected ADR signal of hyperglycemia is identified for atorvastatin. Additionally, several new ADR signals, including constipation, regurgitation, abdominal pain, facial edema and asthenia, also merit attention. Regular monitoring of bilirubin, blood CK and blood glucose levels is critical when statins are used clinically. Risks should be identified as early as possible. Medications have to be adjusted and genetic screening is conducted when necessary to ensure rational clinical use of drugs.

Key words: Statins, Reporting Odds Ratio, Liver Injury, Rhabdomyolysis, Hyperglycemia, Adverse Drug Reaction, Signal Analysis