Worried About Using Statins? Don't Be.

By Josh Bloom — Feb 07, 2026

Statins have been blamed for everything short of causing bad hair days—especially by the alternative-medicine crowd, who treat “Lipitor” like it’s a controlled substance. A new Lancet meta-analysis of the best double-blind trial data available shows that most of the scary side effects on statin labels simply don’t hold up.

Image: ACSH

If you tell a naturopath, chiropractor, or other statin-hater that you’re taking a statin, chances are you’ll get a withering look — the kind that says, “Enjoy the poison, fool.” Or a slow head shake that seems to say, “Been nice knowing you.”

Perhaps even more likely is that your diet and lifestyle will be judged — or at least subtly blamed — along with some sage advice like: “I’ve tried a high-protein, low-barbed-wire diet and never felt better!”

Whether it's liver cleanses or red yeast rice, [1] doesn't matter. Anything is better than putting a statin into your body, right?

No. That's not right, and a new, very thorough, massive meta-analysis of double-blind randomized trials just published in The Lancet should (but probably won't) shut up the alternative medicine/antipharmaceutical gang. After years of debate, it should be crystal clear that statins are much safer than previously thought.

The Study

There are studies, and there are studies. Many (most?) are crap. This one is not. Why?

The authors analyzed adverse events from 19 large double-blind statin-versus-placebo trials—the gold standard for separating the clinical wheat from the chaff and distinguishing real side effects from false positives.

The study included a massive dataset of 123,940 participants, large enough to detect even small risk differences.
The median follow-up was 4.5 years, long enough for side effects to appear that may have been missed in shorter trials.
A second analysis compared two groups of statin users (30,724 participants in total) randomized to higher-dose versus lower-dose statin therapy, with a median follow-up of 5.0 years—a built-in test of whether any harms increase with dose (one of the strongest clues for causation).

Conclusion: These trials were sufficiently powered to accurately assess the real downsides of statin use—or show that most of the supposed downsides simply aren’t there.

This is about as good as it gets for safety data.

How many “labeled side effects” were real?

This is where the safety of statin use really stands out.

A total of 66 prespecified adverse outcomes listed in statin product labels were studied. Only four showed a statistically reliable excess risk, while 62 did not. In other words, most of the side effects people worry about are just lists on the label or theoretical risks, not harms supported by the data.

How were the 66 outcomes (side effects) determined? The researchers reviewed official statin drug labels, combined overlapping side-effect terms into 66 categories, and then tested those categories in the trial data [2].

The real side effects

The only four side effects that held up after correction were abnormal liver transaminases, other liver-function test abnormalities, urinary composition changes, and edema. For each one, the authors reported a relative risk—how much more common the event was on statins than on placebo—and an absolute risk, which gives the actual difference in real-world terms (for example, a few extra cases per 10,000 people per year).

Abnormal liver transaminases: 0.30%/year vs 0.22%/year (RR 1.41) – about 9 extra cases per 10,000 per year
Other liver-test abnormalities: 0.25%/year vs 0.20%/year (RR 1.26) – about 5 extra cases per 10,000 per year
Combined liver-test abnormalities: about 13 extra cases per 10,000 per year
Urinary composition changes: 0.21%/year vs 0.18%/year (RR 1.18) – about 3 extra cases per 10,000 per year
Edema: 1.38%/year vs 1.31%/year (RR 1.07) – about 7 extra cases per 10,000 per year

In other words, even when statins did increase risk, we’re talking about a few extra events per 10,000 people per year—not the apocalyptic side-effect profile statin critics love to imply. And it’s well known that statins can affect liver enzymes; this is nothing new.

Risks vs. Benefits: Benefits Win Hands Down

Of course, a drug's safety means nothing without also considering its benefits.

An effective statin regimen for 5 years in 10,000 patients typically prevents ~1000 major vascular events in secondary prevention (a 10% absolute benefit) and ~500 major vascular events in primary prevention
(5% absolute benefit). This is why the authors argue that the risk/benefit ratio is wildly favorable.

Other infrequent effects

Rhabdomyolysis, which half of statin patients think they have, really affects only ~2–3 per 100,000 person-years (tiny). And the absolute difference in myopathy is tinier; ~1 per 10,000 person-years

There are also some increases in diabetes, usually occurring in people already near the diabetes threshold

Bottom line

If you only remember 5 numbers:

123,940 people in placebo-controlled double-blind trials (a huge number)
62 of 66 label side effects: no reliable causal signal (a surprisingly large number)
Liver enzyme abnormalities: RR 1.41, but only 0.09%/yr absolute excess (a minuscule number)
Combined liver-test excess: 0.13%/yr (~13 per 10,000 per year). This is the data I found most surprising: liver enzyme elevations have often been considered to be the rule, not the exception, in statin therapy.
Statins prevent ~5–10% absolute major vascular events over 5 years (depending on risk)

So yes, your naturopath may glare at you. But the data are glaring right back.

NOTES:

[1] Red yeast rice isn’t a “natural alternative” to statins — it contains monacolin K, aka lovastatin. Lovastatin is an older, lower-potency statin originally sold under the brand name Mevacor and is rarely used today. This means people who refuse statins but take red yeast rice are basically taking a statin anyway—just in an unregulated, inconsistent, mystery dose.

[2] The authors compiled side-effect terms by reviewing statin Summaries of Product Characteristics (SmPCs)—the official European drug labels, similar to the FDA’s Prescribing Information. Because labels list many overlapping or redundant terms, they grouped related ones together into 66 broader categories before testing them in the trial database.

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Josh Bloom

Director of Chemical and Pharmaceutical Science

Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.