Millions of Americans take statins to manage high cholesterol and reduce their risk of cardiovascular events like heart attack and stroke. However, concerns about potential side effects often lead individuals who could benefit from these medications to avoid them. Recent research is challenging long-held beliefs about the prevalence and severity of statin-related adverse effects, offering a more reassuring picture of their safety profile.
Common Fears Don’t Align with Evidence
For years, statins have been associated with a long list of potential side effects, ranging from muscle pain and dizziness to memory loss and liver problems. But a new research review suggests that many of these concerns are largely unfounded. The analysis, published recently, indicates that statins do not cause nearly as many of the over 60 possible side effects listed on drug packaging as previously thought.
“I think this underscores what most cardiologists and physicians in general have known for a long time – that statins are incredibly safe,” says Omar K. Siddiqi, MD, an assistant professor of cardiovascular medicine and director of the Cardiovascular Medicine Fellowship Program at Boston Medical Center in Massachusetts.
Dr. Siddiqi explains that the perception of statins as dangerous medications has become somewhat of a “folklore,” particularly regarding muscle breakdown and pain. “I’ve even heard people say things like they’re the most dangerous medications you can take, and that’s been kind of popularized in the general media.”
Large-Scale Analysis Reveals Limited Risks
Researchers analyzed data from over 150,000 participants across 23 large randomized clinical trials. These trials compared the effects of statins to a placebo, or stronger-acting statins to milder ones. The findings revealed a similar frequency of reported side effects between those taking statins and those taking a placebo. This suggests that many of the symptoms experienced by patients are not necessarily caused by the medication itself.
For example, cognitive or memory issues were reported in approximately 0.2 percent of participants in both the statin and placebo groups, indicating no significant difference between the two. “In this latest work, we found no significant excess risk with statins for almost all the conditions listed in package leaflets as potential side effects,” says Christina Reith, PhD, an associate professor at the University of Oxford’s Oxford Population Health in England, and lead author of the study.
The review found no increased risk from statin use for a range of conditions, including:
- Depression
- Sleep disturbance
- Erectile dysfunction
- Weight gain
- Nausea
- Fatigue
- Headache
A small increase – around 1 percent – in the risk of muscle pain was observed in those taking statins, but this was largely confined to the first year of treatment. There was a 0.1 percent increased risk of liver blood test abnormalities, though this did not translate into an increase in reports of actual liver disease, suggesting the abnormalities were unlikely to lead to serious liver issues.
Dr. Siddiqi notes that while these lab-detected risks are rare in clinical practice, they can occur. “I think the side effects that you can detect on a lab test are almost unheard of, but they do happen and there are real people who have them – so we’re not undermining that.” The analysis did identify urinary changes and tissue swelling as statin side effects supported by evidence.
Study Limitations and Practical Considerations
The researchers acknowledge some limitations to their study. The clinical trials analyzed had a maximum duration of seven years, meaning potential long-term side effects beyond that timeframe were not assessed. The data relied on patient reports of adverse events rather than comprehensive biochemical laboratory data, which could potentially underestimate the incidence of certain side effects, such as liver abnormalities. However, the lack of increased reports of serious liver outcomes suggests this is unlikely to significantly alter the study’s conclusions.
There are multiple types of statins available, and individuals who experience side effects with one type may tolerate another better. “If somebody develops symptoms from one statin, that does not mean that that’s a drug class effect, so they may actually tolerate other statins better,” Dr. Siddiqi says.
For patients considering or currently taking statins, the following recommendations are important:
- Take statins exactly as prescribed by your healthcare provider.
- Do not suddenly stop taking statins without consulting a doctor.
- Discuss any symptoms or concerns with your healthcare provider.
The researchers emphasize that the benefits of statins in preventing heart attack and stroke outweigh the risks for individuals at risk of cardiovascular disease. “Statins are potentially lifesaving treatments for people who are at risk from and stroke, which remains a leading cause of death and disability worldwide,” Dr. Reith says. “Statin drug packaging and other sources of health information for statins should be reviewed to enable doctors and patients to make informed decisions.”
