Meta-Analysis Identifies Few Adverse Events Attributed to Statin Use

WEDNESDAY, Feb. 11, 2026 (HealthDay News) — Few conditions that are listed in product labeling as potential undesirable effects of statins are actually attributed to statins, according to a meta-analysis published online Feb. 5 in The Lancet.

Christina Reith, Ph.D., from the Nuffield Department of Population Health at the University of Oxford in the United Kingdom, and colleagues conducted a meta-analysis of individual participant-level data from double-blind randomized controlled trials of statin therapy to generate a list of all undesirable effects listed in statin Summaries of Product Characteristics. Nineteen trials compared statins (atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin) versus placebo, and included 123,940 participants.

The researchers found that only four of 66 further undesirable outcomes that had been attributed to statins were false discovery rate- significant in addition to previously reported effects on muscle outcomes and diabetes: abnormal liver transaminases, other liver function test abnormalities, urinary composition alteration, and edema (rate ratios, 1.41, 1.26, 1.18, and 1.07, respectively). Significant excesses for abnormal liver transaminases and other liver function test abnormalities were seen in analysis of four trials of more intensive versus less intensive statin regimens, but no significant excess was found for urinary composition alteration or edema.

“Our study provides reassurance that, for most people, the risk of side effects is greatly outweighed by the benefits of statins,” Reith said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

Abstract/Full Text