Lancet

Statin labels may overstate many side-effect risks, major meta-analysis suggests

February 9, 2026

In a meta-analysis of 19 large double-blind randomized controlled trials (N = 123,940; median follow-up, 4.5 years), investigators evaluated 66 adverse outcomes listed in statin product labels. After controlling for false discovery, only four showed a statistically significant excess with statins beyond known muscle effects and diabetes: abnormal liver transaminases, other liver function test abnormalities (absolute excess ~0.13%/year for combined liver test abnormality), urinary composition changes, and edema. Analysis of four trials comparing higher‑intensity vs. lower‑intensity statin therapy showed that liver test abnormalities occurred more often with more intensive regimens, indicating a dose‑related effect, while rates of urinary changes and edema didn’t differ meaningfully between groups. Rates of cognitive impairment, depression, sleep disturbance, peripheral neuropathy, and sexual dysfunction were similar with statin and placebo.

Clinical takeaway: When considering or prescribing statins, clinicians can confidently counsel patients that most listed side effects are not supported by rigorous evidence, while continuing to monitor for liver enzyme changes and other rare but measurable risks.

Source:

Reith C, et al. (2026, February 5). Lancet. Assessment of adverse effects attributed to statin therapy in product labels: a meta-analysis of double-blind randomised controlled trials. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01578-8/fulltext