Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014–2022)

Atorvastatin was associated with a higher number of ADR reports and a higher proportion of serious ADRs than the other statins. Atorvastatin may cause off-label ADRs such as back pain, increased blood bilirubin, bone pain, hemorrhage, hepatic failure, and hepatocellular injury. Drug instructions should be enriched for better labeling of ADRs.