Do Statins Really Have That Many Side Effects? New Research Challenges Common Fears

There’s good news for the 86 million Americans with high cholesterol. A new study from researchers at the University of Oxford found that statins, a group of cholesterol-lowering medications, do not cause the majority of side effects listed on their packaging, such as weight gain, nausea, and fatigue.

“This finding has huge public health implications,” said Michael D. Shapiro, DO, MCR, director of the Center for Preventive Cardiology at Wake Forest Baptist Health, who was not involved in the new research. “Statins are potentially life-saving drugs, and many people deny themselves of their potential benefits for fear of side effects.”

Sussing Out Side Effects

Although common, high cholesterol is a serious condition that can increase your risk of cardiovascular disease, particularly heart attack and stroke. Statins are highly effective at lowering cholesterol, but the evidence behind many of the listed side effects that discourage their use “is, in many cases, very weak,” explained lead study author Christina Reith, PhD, an associate professor at Oxford Population Health.

That’s why she and her team have been testing statin side effects for years.

In 2022, they looked at the most common symptom: muscle aches and pains. Their research found that around a quarter of patients experienced these muscle symptoms, but they were about as common in the placebo group. “There was only about 1% excess risk of muscle symptoms with statins, which largely occurred in the first year of treatment,” Reith said.

It is well established that statins can cause a serious muscle condition called myopathy, but “this is incredibly rare, affecting only one in every 10,000 people treated with a statin,” Reith said.

In 2024, the team studied the link between statins and diabetes—another potential side effect—and discovered that statins can cause a small rise in blood sugar, but treatment typically led to a new diabetes diagnosis only in patients who already had high blood sugar levels.

In the newest study, published in The Lancet on February 5, the researchers assessed 66 other potential side effects listed on statin product labels, such as depression, impaired cognition, sleep disturbance, and erectile dysfunction. They gathered data from 23 large, randomized studies, including about 124,000 participants in 19 trials comparing the effects of statins against a placebo, and around 30,700 participants in four trials comparing more intensive versus less intensive statin therapy.

What Researchers Found

The evidence revealed that statins did not increase the risk of almost all of the potential side effects. “Most symptoms commonly attributed to statins occur at the same rate in people taking placebo, meaning they are not caused by the medication,” explained Shapiro.

Only four of the tested side effects showed any additional risk in the statin group. There was a small increased risk of liver blood test abnormalities, but no additional risk of serious liver problems, such as hepatitis or liver failure. The study also found small increases in the risk of urinary composition changes and edema (swelling from fluid build-up), which could be signs of kidney problems. But Reith noted these risks were of “uncertain clinical significance.”

“What this shows is that the known benefits of statins substantially outweigh their risks,” Reith said.

Shapiro commended the strength of the new study. “This is the most comprehensive analysis ever conducted on statin side effects,” he said. Gordon Huggins, MD, a cardiologist at Tufts Medical Center, agreed that the research was high quality.

Huggins also told Health he was not entirely surprised by the results. “I have been prescribing statins to patients for a long time, and the level of concern about different problems has always seemed to be higher than what we observe,” he said. “My clinical experience is that the vast majority of patients tolerate statins quite well.”

Why the Findings Matter

Experts said the new study should alleviate patient concerns about many statin side effects, and may even lead to a review of current statin packaging and information.

“The main established risks,” Shapiro continued, “remain muscle symptoms, which occur in a small minority and usually early; a small increase in diabetes risk, mostly in people already near the diagnostic threshold; and mild liver enzyme elevations, which rarely translate into actual liver disease.”

The only groups who may carry a greater risk of side effects are people with pre-existing liver problems or a high risk of diabetes. “Even in these groups, the absolute risks are small, and cardiovascular protection usually outweighs potential harms,” Shapiro said. Huggins also noted that patients older than 75 may be more sensitive to statins and typically do better with a lower dose.

If you’re curious about statins, experts recommended talking to your doctor about your cholesterol levels and individual cardiovascular disease risk to determine if taking one is right for you.