Major Study Finds Statins Safer Than Previously Thought

Millions of people around the world rely on statins to lower their cholesterol and reduce their risk of heart disease, but for years, warnings about possible side effects have made some patients and even doctors think twice about prescribing or taking these widely used medications. Now, a sweeping new review of clinical trial evidence has found that statins are far safer than many have been led to believe—and that the vast majority of side effects listed on drug packaging are not actually caused by the medication at all.

The findings, published in The Lancet on February 5, 2026, come from the Cholesterol Treatment Trialists' (CTT) Collaboration, a global initiative spearheaded by Oxford Population Health and the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney. The analysis pooled data from 23 large-scale randomized controlled trials, covering more than 154,000 participants and tracking outcomes over a median of nearly five years. The research was funded by the British Heart Foundation, UKRI Medical Research Council, and the Australian National Health and Medical Research Council, according to Reuters and the BBC.

Statins, which include common drugs like atorvastatin (Lipitor), simvastatin (Zocor), rosuvastatin (Crestor), fluvastatin (Lescol), and pravastatin (Pravachol), are prescribed to lower LDL—or "bad"—cholesterol. Their effectiveness at reducing the risk of heart attack and stroke has been repeatedly proven, and cardiovascular disease remains a leading cause of death globally—accounting for around 20 million deaths each year and a quarter of all deaths in the UK alone, according to the BBC.

Yet, despite their life-saving potential, concerns about possible side effects have led many people at risk of heart attack or stroke to avoid statins. As Professor Christina Reith, lead author of the study and an associate professor at Oxford Population Health, put it to Reuters, “Ongoing confusion and concern, not just in patients, but also many doctors regarding potential statin side effects, means that many people are not willing to start statins or (continue) them even if they're at high risk of having either a first or recurrent heart attack or stroke, and may derive really significant benefit from them.”

So what did the researchers actually find? The team meticulously analyzed reports of 66 possible side effects listed on statin package inserts. For almost all of them—including memory loss, depression, sleep disturbance, weight gain, erectile dysfunction, gastrointestinal issues, nervous system impairments, and more—there was no significant difference in rates between patients taking statins and those on a placebo. In fact, as the BBC reported, “Reports of adverse effects were almost identical in the placebo group that was not on the medication, suggesting statins are not the cause.”

Only four side effects showed a slight increase among statin users, and even then, these were rare and generally mild. The four were: minor liver abnormalities (including changes in liver blood tests), urine changes, tissue swelling or swollen ankles (edema), and a small increase in blood sugar levels. For example, the risk of liver blood test abnormalities increased by only about 0.1%, and there was no corresponding rise in serious liver diseases such as hepatitis or liver failure. Changes in urine composition and swelling were also uncommon, affecting fewer than 1% and 1.5% of patients, respectively, with only a marginal increase compared to placebos.

As for muscle symptoms, which have long been a concern among statin users, the evidence was reassuring: myopathy—a muscle disorder—occurred in about 1 in 10,000 patients per year, mostly in the first year of treatment, with no excess risk thereafter. Statins have also been associated with a small increase in blood sugar, which could potentially bring on diabetes sooner in people already at high risk, but again, this effect was rare and well-documented.

Professor Sir Rory Collins, the review’s senior author and emeritus professor of medicine and epidemiology at Oxford, emphasized the importance of distinguishing between real and imagined risks. As he told Reuters, “Statin product labels list certain adverse health outcomes as potential treatment-related effects based mainly on information from non-randomized studies which may be subject to bias. We brought together all of the information from large randomized trials to assess the evidence reliably. Now that we know that statins do not cause the majority of side effects listed in package leaflets, statin information requires rapid revision to help patients and doctors make better-informed health decisions.”

Professor Bryan Williams, chief scientific and medical officer at the British Heart Foundation, echoed this call, telling the BBC, "Prescribers have been intoxicated by this negative publicity. We are absolutely delighted to see the outcomes of this study. These findings should provide very powerful reassurance." Williams further urged regulators to update package inserts to reflect the new evidence. “Nobody's disputing the fact that patients get adverse effects throughout their life. The big question is, are they related to the drug that they're taking? And the answer with statins, is in large part, no.”

The review authors were clear: the benefits of statins in preventing heart attacks and strokes far outweigh the small risk of side effects for most people. “Our study provides reassurance that, for most people, the risk of side effects is greatly outweighed by the benefits,” said Professor Reith. She added, “That’s not to say people do not experience things while on them, but we now have really good evidence that statins are not the cause of common problems.”

The research also highlighted the rigorous nature of the trials included in the analysis. All were double-blind, meaning neither the participants nor the researchers knew who was receiving the statin or the placebo, which helps eliminate bias. The trials involved at least 1,000 participants each and followed patients for a median of nearly five years, providing a robust dataset for the meta-analysis.

Importantly, the study’s findings serve as a much-needed counter to years of misinformation and fear-mongering about statin safety. As the BBC noted, “Experts stress statins save lives, but if you have any problem with your medication you should chat with your doctor.” Recognizing which side effects might genuinely be associated with statins will help doctors make better decisions about when alternative treatments might be needed, but for the vast majority of patients, the message is clear: statins are safe, effective, and should not be avoided due to misplaced fears.

With cardiovascular disease continuing to take millions of lives each year, the hope is that these findings will prompt an urgent revision of statin information leaflets, encourage more informed conversations between patients and doctors, and ultimately save lives by ensuring that those who stand to benefit most from statins are not deterred by unfounded concerns.