The People's Perspective on Medicine

Statins and ALS? Is This Possible Side Effect Too Scary to Study?

Some side effects are so scary that no one wants to talk about them. The FDA says there is no link between statins and ALS. But a new analysis of FDA data suggests there may be a connection.
Statins, Statin pills and a warning sign,

When I was a child I hated the scary parts of movies. Whenever the scene became too terrifying I closed my eyes and covered my ears. Some things seem so frightening that we can’t bear to face them. That may also be true for drug side effects. We suspect that some physicians would prefer to close their eyes and cover their ears when prescription drug commercials on TV mention adverse reactions like heart attacks, strokes and cancer. One drug complication that many health professionals might prefer to ignore is a possible link between statins and ALS.

Amyotrophic Lateral Sclerosis (ALS):

There are a lot of very scary diseases in this world. Cancer ranks very high because treatment outcomes are unpredictable. More than 1.7 million people will be diagnosed with cancer this year and over 600,000 will die (National Cancer Institute).

Neurological conditions are not far behind cancer when it comes to the fear factor. Alzheimer’s, Huntington’s and Parkinson’s disease are not curable. They take a terrible toll.

But ALS or amyotrophic lateral sclerosis seems to us to be even worse. It is a rare disease. You may have heard of it by the name “Lou Gehrig’s disease” because it is the condition that took the baseball player’s life.

It robs people of their muscular control. As muscles weaken and waste away, patients lose the ability to walk, talk, swallow, eat or even breathe. ALS is personal for me. I lost a close cousin to this horrific disease. No family should have to suffer the torment of Lou Gehrig’s disease.

Statins and ALS?

No one knows what causes ALS. Some suspect a gene mutation. Others blame it on a chemical imbalance in the brain, though what might trigger such an imbalance remains a mystery. For more than a decade there have been reports of an ALS-like condition linked to statins.

We can think of no scarier drug side effect than ALS. We first wrote about a possible link between statin cholesterol-lowering drugs and an ALS-like syndrome in 2007.

A report had appeared in the journal Drug Safety suggesting a possible association (June 2007).

After we wrote about this analysis from the WHO (World Health Organization) Foundation Collaborating Centre for International Drug Monitoring, we heard from many people who believed that they or a loved one suffered ALS after taking a statin drug.

Rob wrote on August 7, 2007:

“In February my father was diagnosed with a variant of ALS. Prior to his diagnosis he was taking Lipitor and was convinced that the drug was responsible for his symptoms. He stopped taking it after he noticed symptoms, but the disease has continued to progress.”

E.L.B. wrote on August 9, 2007:

“I had been on Lipitor for 5 years, and I noticed muscle weakness, poor control of my legs and feet, and some difficulty walking. I mentioned this to my doctor, and he discounted it as aging and not eating enough protein.”

Maryann added this on September 5, 2007:

“My father was prescribed Lipitor in March of 2004. Subsequently he developed muscle weakness and numbing and stopped taking it. The weakness did not go away. He got progressively weaker and was told to see a neurologist.
In September of 2004 the neurologist diagnosed him with ALS. When I told her Lipitor triggered the ALS back in October of 2004, the neurologist denied the connection. In January 2005 she said they’re now investigating a possible link.

“Prior to taking Lipitor my dad was very fit and strong, I couldn’t keep up with when we hiked. He died in March of 2005, one month after his birthday and less than one year after taking Lipitor.”

Such cases could be coincidence. Millions of people take statins and a few could develop ALS regardless of taking a drug like atorvastatin, rosuvastatin or simvastatin. That was certainly the message we received from many health professionals. But the stories we were receiving from readers of our syndicated newspaper column and visitors to this website made us wonder what was going on.

Where was the FDA?

The FDA initially reported a possible link between statins and ALS. Later, the agency said that it could find no connection between statins and ALS (Pharmacoepidemiology and Drug Safety, Nov. 2008).

The authors reported the following:


“We detected disproportionate reporting of amyotrophic lateral sclerosis (ALS) with HMG-CoA-reductase inhibitors (statins) in the Food and Drug Administration’s (FDA) spontaneous adverse event (AE) reporting system (AERS).”


“There were 91 US and foreign reports of ALS with statins in AERS. The data mining signal scores for ALS and statins ranged from 8.5 to 1.6. Data were obtained from 41 statin clinical trials ranging in duration from 6 months to 5 years and representing approximately 200,000 patient-years of exposure to statin and approximately 200,000 patient-years of exposure to placebo. Nine cases of ALS were reported in statin-treated patients and 10 cases in placebo-treated patients.”


“Although we observed a data mining signal for ALS with statins in FDA’s AERS, retrospective analyses of 41 statin clinical trials did not reveal an increased incidence of ALS in subjects treated with a statin compared with placebo.”

Update Over the Last Decade:

The agency presumably thought it had laid the concern about a link between statins and ALS to rest, but it has not disappeared. The most recent research on a link between statin drug use and ALS was published earlier this year (Drug Safety, April 2018).

For this study, the researchers reviewed the FDA’s database of adverse event reports, where doctors and patients describe suspected side effects of medications. They looked to see whether there was a disproportionate rate of ALS reports for statins compared to other drugs, and they found that there is. An analysis of reports for individual statin drugs showed that they are not all alike. According to the investigators:

“Standalone statin drugs were each associated with significantly elevated RORs [reporting odds ratios] for ALS, with RORs from 9.1 to 107, extending prior evidence for statins as a group.”

The authors concluded:

“Our analysis of FAERS [FDA Adverse Event Reporting System] data identified materially and statistically significantly elevated reporting of ALS-like conditions with individual statin drugs relative to other drug classes, extending previous findings linking statins as a class to elevated ALS reporting.”

“…These findings add to concerns about a possible connection between statin use and the development of ALS and ALS-related conditions.”

Stories from Readers:

ALS is quite rare, so even increasing the odds of developing it by 10 or 20 times doesn’t make it likely. It is, however, a gruesome disease. Readers have offered comments like these:

“My mom took Lipitor for a year, but after developing muscle aches and pains she went off it. She was diagnosed with ALS in September 2009 and passed away February 2010 at 73 years old.”

Another wrote:

“My husband was on Lipitor for a couple of years. After hip replacement surgery he developed drop foot.

“Eventually he moved to a walker, then a full wheelchair and currently he is not mobile on his own on any level. When he was diagnosed with ALS they IMMEDIATELY took him off Lipitor.

“The fact that Lipitor is known to cause muscle side effects makes me wonder if the drug was the cause of his ALS. We went from mountain biking, hiking, backpacking, camping, golfing and other strenuous activities to absolutely nothing in six short months. Our lives are very challenging. His legs are dead and have to be manually moved, his upper body is weakening and he has trouble maintaining his body upright when sitting. He can’t sit up on his own.”

The People’s Pharmacy Perspective on Statins and ALS:

No one can determine whether any individual case of Lou Gehrig’s disease was triggered by taking a statin. Fortunately, this disease is extremely rare. The risk that any given individual will develop a severe muscle disease like ALS from a statin is extremely small. For people with severe heart disease, the benefits of a statin will likely outweigh any small risk of developing ALS.

That said, we suspect that we have received far more reports of severe muscle disease linked to statins than the FDA. On this one post we have over 600 comments:

Diane in Illinois poses a question we have been asking:

“My husband just died of ALS. He too was on statin drugs for a few years. Finally, the evidence of a connection is starting to show up. What a tragedy that so many lives are being taken by this horrific disease. My family is heartbroken. How many people will have to die before the FDA puts out a warning?”

We think it is past time for the FDA to stop covering its eyes and take a good hard look at its data about this alarming side effect. We would happily share the reports on our website, but the FDA has shown no interest in reviewing the stories people have shared. Perhaps this is one side effect that is just too scary for the FDA to consider. Might this be a case of  “see no evil, hear no evil, speak no evil“?

Share your own story about statins and ALS-like syndrome in the comment section below. If you would like to learn about another extremely serious muscle problem called myositis and its link to statins, here is a link to recent research.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Reply to Beatrice M., Jackson NJ, September 4, 2018 at 2:16 pm:

“I have been taking Red Yeast Rice, 600 mg. four a day, as I believe it is a natural statin. My cardiologist is fine with this. So, can this natural choice still cause these symptoms? My legs are weak, and my hands and feet are getting numb.”

Yes, I believe it’s possible. Red yeast rice (RYR) is a natural form of lovastatin, IIRC.

My husband took RYR for several years with no symptoms. Then, after pressure from his PCP to lower his LDL below 100, my husband doubled his dose. Within a few weeks, he had pain and cramping in his trapezius and shoulder muscles. I got him to start taking CoQ10, which helped. After several more months, he and I both noticed that he was having trouble thinking of words during conversations–and he’s only in his early 60s. So he stopped the RYR. Within a few weeks, his speech was back to normal.

I lost my brother-in-law at age 43 and my Aunt who was in her sixties to ALS – their doctors linked the high probability that the statin drugs they were on for cholesterol triggered whatever it is that causes this horrible disease. I wouldn’t wish ALS on my worst enemy. It is horrifying to watch loved ones die of such a horrendous disease. Even a heart attack can be treated- I’d take my chances before ever swallowing a statin drug!

Degenerative Myelopathy in dogs is the canine equivalent of human ALS. It most commonly affects German Shepherd Dogs and is thought to have some genetic element. I wonder if anyone has studied whether ALS is more common in some human bloodlines than others.

Another drug that can have similar side-effects to statins are hypertension medications Angiotensin Receptor Blockers (ARBs). They target the same cytochrome P450 pathway that statins do, and they can damage mitochondrial function the way that statins can. Mitochondria are organelles within cells that produce energy for the cell – all cells. My husband started developing muscle weakness while taking an ARB. Formerly athletic, capable of hiking and biking long distances, he got to the point where he could no longer walk a quarter of a mile and one night he just collapsed when his leg muscles gave out.

Fortunately, his physician was not only open-minded, he had a very broad and deep understanding of physiology and pharmacology. He took my husband’s concerns seriously that the medication was the problem. My husband weaned off the medication and used supplements to lower his BP and repair the muscle damage. It took six months, but he finally managed to get back to his former level of fitness, though I think there is probably some permanent muscle atrophy in his legs that he’s able to compensate for.

If you’re not taking a statin but you are taking an ARB and you have unexplained muscle wasting symptoms (pain, weakness, atrophy, lack of coordination), consider the possibility that this medication could be the culprit. It might be rare, but it might not. We’re only now starting to hear about the connection of statins to muscle damage, and that connection has been well-documented for several years now.

I took pravastatin for almost a whole month of January 2017. Before taking the drug, I was physically very active- gym 3 times a week; frequent walks; avid pickleball player 3 times a week etc. By the end of January, I couldn’t walk across the parking lot to get into the gym; I was not able to walk around the block. I stopped taking the drug after 30 pills. I had not been advised to take CoQ10 along with the statin, but now know it’s strongly recommended in other countries. It took many, many months to recover to a better physical condition (I can make it around the block now), but I’m quite certain, I will never regain my previous level. I now take CoQ10, but believe the damage has been done and it doesn’t seem to have much effect. Recovery did accelerate to my current level after I started taking alpha-lipoic acid. There is no doubt in my mind that the statin drugs have caused permanent damage.

I only took statins for about 10 days but experienced much trouble swallowing almost immediately, and my esophagus felt like I was choking and regurgitating every night. My legs felt weaker also, and it was hard to go upstairs. Everything reversed quickly after I stopped, though, and all is well now, 8 years later, with no statins.

After a stressful situation my cholesterol went up for first time in my life. Was put on statins for a while and noticed abnormal mental distress so I weaned myself off of them, tweaked my diet until my cholesterol came back down under 200. Two years later I was diagnosed with AV block heart electrical problem, had a pacemaker put in and started taking an ACE inhibitor. My cholesterol skyrocketed, and I was put back on a statin. Immediately started having serious muscle pain so bad I had a difficult time walking. I weaned myself back off statin. Bingo, pain stopped. After reading these stories I believe I did the right thing.

Between serious mental/memory symptoms with possible Alzheimer’s warnings from Statins, and now possible ALS warnings from Statins, I can’t believe anyone is still pushing Statins for high Cholesterol for any reason for anybody.

My sister was prescribed a statin at the age of 61 and immediately began experiencing a feeling of tingling, almost like “static electricity”, in her words, running up and down her arms. She didn’t think anything of it at the time, but within a month, she wasn’t able to lift her right arm. Being a busy, active person, she just thought she had a pinched nerve or something and didn’t think much about it. After a few months, she started having difficulty with her left arm as well, and some difficulty using tools, like knives, knitting needles, and gardening. After a year of testing, she was finally diagnosed with ALS. Her neurologist told her to immediately stop taking the statin, and told her to tell all her family members to not ever take a statin. The damage to her had been done, however, and she died two years after diagnosis. By that time she was completely paralyzed.

For those of us who use niacin in place of statins:should we worry about an ALS connection?

I was prescribed a statin. The low dose didn’t reduce my cholesterol, so the dosage was upped. I had memory loss, muscle aches, and itching. I had to urinate in the middle of the night (and I’m too young for that). I quit the statin, and all my symptoms went away. I learned that most of my many siblings were also on statins, so I warned them. It wasn’t long after that that my oldest sister (who had been on statins) was diagnosed with ALS and died quite quickly thereafter. My other sister won’t heed my warning about statins because her son is a doctor and denies the connection.

So “muscle weakness” is a common side effect – with this suggestion that ALS might be linked, it seems to me that “what exactly is the mechanism causing this muscle weakness?” should be a really important research topic. Is there any explanation on offer? (Would there be just one mechanism?)

Thank you both so much for your website, radio show, podcasts, newsletter, and the information you share. You are such a blessing!

I was prescribed atorvastatin in October 2017. By June 2018 I had lost 10 lbs, down from 110 lbs. I called my GP, and he ordered a blood test. Results showed I had abnormal thyroid readings. I was told to stop atorvastatin and see an Endocrinologist who prescribed Levothyroxine 50 mcg. Since stopping atorvastatin I had gained back 8 lbs. Should I stay off atorvastatin?

I have refused to take statins after muscle and joint pain occurred after a couple of weeks. My drs. still try to talk me into taking one, but I have been taking Red Yeast Rice, 600 mg. four a day, as I believe it is a natural statin. My cardiologist is fine with this. So, can this natural choice still cause these symptoms? My legs are weak, and my hands and feet are getting numb.

The linked article from 2007 mentions the work by Dr. Duane Graveline on this subject. Sadly, he passed away two years ago. His website,, is still available, but not being updated, for those looking for additional information on statins and cholesterol.

I was prescribed atorvastatin after having a mild heart attack in January 2017. The cardiologist told me that, fortunately, I got medical attention very soon, and very little damage was done to my heart. He prescribed the statin, and I took it for about a year and a half.

The reason I stopped taking it (with doctor’s ok) was that I had very harsh pain in my left arm & shoulder, and pain (not quite as bad) in my right arm & shoulder) enough to nearly bring me to tears, when lifting my arms to put on a jacket. He’s recommended that I begin taking Crestor. After reading this article, I have no intention of EVER taking another statin!

In addition, I was told that my A1C was high, so I needed to go on medicine to treat diabetes. I have an appointment coming up with the physician’s assistant that oversees those meds and plan on asking for a change with those, as well, after reading a good deal about them on your website and the Mayo Clinic’s website.

Similarly with HCTZ for blood pressure readings that weren’t extremely high, several years back – after 3 months, the doctor I was seeing at the time said my blood sugar was up and asked, “how long have you had a heart murmur?”, to which my answer was that no one had ever before made any mention of a heart murmur to me. I stopped taking that medication then (again, with his ok).

A good many years ago, I started taking an HRT prescription, after a Physicians Assistant repeatedly encouraged me to do so, for hot flashes. When they didn’t help the hot flashes, plus caused me an unusual chest pain, I stopped taking them (with PA’s ok).

At this point,
1. I have other minor issues that could possibly be side effects of the varied prescriptions I take.
2. I wish I’d been more forceful about not taking statins in the first place.
3. And I wonder if it all started with HRT, then HCTZ years back.

I’m now beginning to search for a source of integrative medicine. I feel quite like a guinea pig!

Thank you for your always informative programs and articles.

I quit taking a statin roughly twenty years ago after repeatedly seeing a full-page discussion by the manufacturer that appeared in the Wall Street Journal. My reading of that material led me to suspect it was linked to my increasingly severe essential tremor. Getting off of it and on to a non-statin cholesterol drug required quite an argument with my internist, which finally ended only after my refusing to take that [expletive] any more. My essential tremor symptoms eased up fairly quickly, and while continuing to worsen over time are only now becoming as severe as they were decades ago. One of my fears for society is that the morons who proposed adding statins to the water supply may someday succeed.

I had always suspected I wasn’t tolerating statins very well, and discontinued my initial Pravstatin 10mg Rx in early 2016 after a month or so. But since my symptoms (muscle weakness and fatigue after exercise) continued after stopping the statins, I shrugged it off, and accepted my cardiologist’s Rx for Rosuvastatin Calcium 5MG prior to heart surgery in 2017.

I complained to him about worsening symptoms, and he let me stop it altogether. But the symptoms continue to worsen, and I’m losing strength in my hands, which (to me) would seem to rule out other known spine issues that I’m looking into, since I initially complained of symptoms that could be related to known scoliosis and stenosis.

My condition continues to deteriorate; I can no longer stand from a full-squat position without other support, and can no longer use thumb-operated tools conventionally. This is my first affliction in my 77 years that I am truly afraid of.

Hi, Joe. Thank you so very much for this article about the side effects of statin drugs. I too used to be highly athletic, working out (literally) daily, and participating in long-distance cycling, swimming and running. But I too was one of those who developed a sudden deterioration in leg muscle strength and pain soon after starting on statin medication. My doctors moved me from one statin to another over a period of several years.

They downplayed my complaints, and insisted on my continuing with the statins, even though my lipid numbers were just slightly outside of recommended range. My condition deteriorated where I couldn’t walk more than a block at most, due to both pain and leg muscle weakness.

When JAMA finally issued a study in July of 2018 that revealed and admitted that statins can cause muscle damage and muscle pain, I decided that “enough is enough” and I’ve thrown the statins away. Hopefully, I may be very slowly recovering from the damage that the statins caused.

To me, quality of life is far more important than any non-tangible, minor “improvement” in my lipid numbers. Statins caused me major – not minor, MAJOR physical and emotional damage. I will write to the FDA and share my experience and insist that they give statins another, in-depth investigation. Thank you for sharing the truth about statins.

I recently was prescribed rosuvastatin 5mg (generic Crestor), after a few years of not taking any statin (by choice). Oddly, I was not scheduled for lab tests after beginning the drug for six months, even though the drugmaker suggests a few weeks.

I never got that far. Within a few days, I began experiencing excruciating pain in specific muscles, following activity targeting use of those muscles (e.g., pulling weeds, moving a heavy item, working out). Some soreness was to be expected, but this pain was different: it was extreme, it followed within about 12 hours of the activity instead of my usual 36-hours-hours-later soreness pattern, it lasted longer, and it did not respond to Tylenol or ibuprofen at all.

In addition, I was developing uncharacteristic weakness in my legs, back, and neck — my muscles fatigued quickly and my endurance for walking any real distance dropped off. With such a small dose, I didn’t immediately suspect the statin. After the third incident, I searched statin side effects and finally discovered these were classic, if not super common, side effects, right down to the lack of response to the OTC pain relievers.

I’m a 73-year-old female with a history of sensitivity to prescription drugs, hence the small starter dose. Yet, without any expectation of trouble on my part, the immediate effects were unmistakable. I stopped taking the statin about 2 weeks after starting it and notified my cardiologist, who agreed with stopping and scheduled me for labs in 3 months “to be sure the medication had cleared from my system.” The side effects began to drop off, but I’m still experiencing a milder version of them. Never, ever again. Thank you , PP, for keeping me alert.

I’ve had increasing muscle pain and neuropathy since I took 10 mg simvastatin starting in Dec 2009. I quit the drug in Aug 2011. In 2012, I had abnormal nerve tests and muscle biopsy but was dismissed by the neurologist who said I had a “mild (unnamed) condition.”

Last year after lower back surgery, my peripheral neuropathy and lower body weakness suddenly worsened with a loss of reflexes, and I was diagnosed with CIDP (chronic inflammatory demyelinating polyneuropathy), like ALS, a rare nerve disease. Currently, I’m trying to find out if the symptoms of this disease are from a surgical complication or if I had a mild, undetected case of CIDP all along.

The real, under-reported danger of statins is that their typical side effects indicate changes to the body that may result in permanent damage or an incurable disease. The US FDA needs to address this issue honestly and very soon.

I think when you overstate your case it can lead to people who stop believing you. There are many good reasons not to take statins without throwing out this ALS scare.

I have been on Lipitor for 20 years. I am now 70 and have had no side effects. My doctor has me taking 100 mg of COQ10 to counter possible muscle cramping. My mom had early heart disease and I have had high cholesterol and hypertension for as long as I can remember. The doctors feel it is essential that I take medication for my cholesterol given my family history. I am taking 40 mg of Lipitor daily, which is a sizable dose. So far so good.

You need to question the need for this statin drug, with all of the side effects discovered daily, and find better approaches to your perceived health problem. Look at Joe and Terry’s many programs on these controversial, $-making drugs!
Jack c

My Mother took Crestor in the summer or 2004. She started having some heaviness in her legs and trouble walking. She had to start using a walker in 2005. Went to two doctors and was diagnosed with PLS half of ALS. We went to the Mayo Clinic in Rochester Minnesota in May 2006. Diagnosed with PLS with a big chance that it would go to ALS. I took her to work on her walker till May 31 2012 when she retired at the age of 72. My brother and I took care of our white angel till she passed away on October 15 2017. She still had the use of her right hand and loved her IPad and changing the channel and watching UT football and basketball and cooking channels. She was one amazing woman and Mother who taught a lot of people to never give up and there was always someone worse off than herself. She was a very humble person and she was MY Precious Mother. Till I see her Again………

A few years ago I was taking Lipitor for a short time. My legs were killing me. Dr. then put me on Pravastatin. After a few years my legs were again a problem & I stopped taking it. Dr. said I need to stay on it so I went back on it & my legs were worse. Dr. sent me to a neurologist & couldn’t find anything wrong. I can’t walk very far, & now I can’t carry anything heavy. When I do grocery shopping I tell them not to put too much in one bag! Before, I could walk for miles with no problem & carry heavy items! I’ve also noticed memory problems but the answer I get is that it’s to be expected at my age! I don’t think so! From what I’m reading I will not get any better. I stopped taking Pravastatin a few weeks ago, I don’t notice any change, I think the damage is done.

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