This is unpublished
A clear glass pill bottle filled with small, white, round pills sits on a clean, light-colored surface next to a silver and black stethoscope. The lighting is bright and clinical, emphasizing the medical theme.
February 11, 2026

Statin side effect warnings overstate the risks, study reports

Recent research shows statins are not linked to an increased risk for 62 of the 66 side effects listed on their labels.
Scroll for more
arrow icon
Back to top

Over the past 30 years, statins have been taken by hundreds of millions of people around the world and have consistently been shown to lower the risk of heart attacks, strokes, and cardiovascular-related deaths. However, concerns about safety have led many to avoid the medications, as statin packaging often lists numerous potential side effects.

According to research recently published in The Lancet, statins do not increase the chance of 62 of the 66 side effects listed on the label. This study represents the most extensive evaluation to date of the evidence behind reported statin side effects. Researchers analyzed 19 randomized controlled trials involving nearly 124,000 participants, with an average follow‑up period of four and a half years.

In addition to some of the known and more common side effects – muscle pain and increases in blood sugar levels – the study identified evidence for four potential side effects: changes in liver tests, minor liver irregularities, alterations in urine, and tissue swelling. However, researchers note that the risks associated with these outcomes are small. These outcomes have resulted in the modification of the package insert of several statins.

In comparison, the authors reported that using moderate-intensity statins for five years would generally prevent around 1,000 major vascular events per 10,000 patients with existing cardiovascular disease, and about 500 events per 10,000 high‑risk patients without prior events – helping to contextualize the relatively small increase in adverse event risks.

Benefits outweigh risks

Overall, the study found no significant excess risk with statins for nearly all of the conditions listed on the medicine’s packaging. These findings reinforce previous conclusions that any risks associated with statin therapy are greatly outweighed by their cardiovascular benefits.

Jeff Probstfield“This research provides important reassurance for patients and clinicians alike,” says co-author Dr. Jeffrey Probstfield, professor emeritus (Cardiology). “Despite the long list of possible side effects on statin labels, the evidence shows that that nearly all of them occur at rates comparable to those seen with placebo. This study reinforces what we see in practice every day: statins are among the safest and most effective medications we have for preventing heart attacks and strokes.”

The researchers urge regulatory authorities to revise and update statin product labels so that clinicians, patients, and the public can make informed decisions regarding statin therapy.