Prolia Side Effects: You Just Can't Make This One Up - Regenexx®

Prolia Side Effects: You Just Can’t Make This One Up


prolia side effects

The United States of Pharma is a strange place where companies can take lab discoveries that seem simple and really screw real people up. Today’s entry is a drug called Prolia that I have encountered before. When I looked it up back then, I was astounded and disturbed at how this drug worked. Now it looks like I was right: this stuff is bad news.

What Is Prolia (Denosumab)?

Prolia (denosumab) is a drug for osteoporosis that works by blocking a receptor ligand called RANKL. It was approved in 2010 by the FDA with much fanfare because it’s a monoclonal antibody that targets the “key” (RNKL) that fits into the receptor “lock” (RANK). When the body inserts the RANKL keys into the RANK locks on the cells that break down bone (osteoclasts), they can’t perform their job. Hence, the cells that break down bone are inactivated, and thus bone density increases because there is less bone breakdown. Simple, right? Not so fast…

What Could Go Wrong?

It turns out that the RANK receptor lives on lots of cell types, including skeletal muscle, liver, colon, small intestine, adrenal gland, bone, breast glands, skin cells, prostate, and pancreas! Hence, injecting an antibody to deactivate the RANK receptors on all of these cells just sounds like a really bad idea. In addition, the RANK receptor also plays a role in immunity!

My Patient on Prolia

About a year ago, I had a patient on Prolia who had been having good results managing her severe ankle arthritis by going to our licensed advanced stem cell site in Grand Cayman. She was coming down for another treatment and had been placed on Prolia for osteoporosis. I looked it up and soon learned that the RANK receptor also lived on mesenchymal stem cells (MSCs). I had misgivings about how it could impact her stem cells, so I told her to get off it. Despite getting off it, the Cayman lab was unable to grow her stem cells that trip when they had no issues before. We eventually did get her cells to culture after more time had passed since discontinuing the drug.

Prolia Side Effects: The New Study on Prolia Is Really Scary

The new research concerns the cases of nine women who had taken Prolia and then stopped the drug. They then had between them some 50 vertebral fractures in short order that the paper blamed on a rebound effect from the drug. Yikes!

Why could this be happening? We saw that the drug didn’t do great things to bone marrow stem cells. Hence, it’s possible that in addition to turning off the cells that break down bone, it may also be hurting the cells that create the cells that make bone (mesenchymal stem cells).

The upshot? There is no cell-surface-receptor free lunch! If you break one thing in the body, it usually has many workarounds. So antibodies that target receptors on many cells are a really dumb idea. As far as Prolia is concerned, how did this stuff get approved? In the meantime, if you’re on Prolia, definitely consult your physician before getting off.




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Read 30 Comments
  1. To whom it may concern;
    I am very interested in stem cell rearch & would like to talk with some one about this!

    Thank you
    E. Slabo

    1. Dot,

      There were 50 vetebral fractures among 9 women in a Prolia study once they stopped taking the drug. We saw that the drug didn’t do great things to bone marrow stem cells. Hence, it’s possible that in addition to turning off the cells that break down bone, it may also be hurting the cells that create the cells that make bone (mesenchymal stem cells).

  2. The worse decision I made was to I take Prolia from 2010 to Oct 2014. In Sept 2015 I suffered multiple spinal compression and endplate fractures! This has been life changing.

  3. My bone densitometry tests show improvement in my bone mass since receiving Prolia injections for a few years. But I was recently diagnosed with acute Adrenal Fatigue Syndrome. Is there a connection?

    1. B. Hayes,

      Adrenal Fatigue Syndrome is not listed as a side effect of Prolia. However with today’s sledgehammer drugs, which because they haven’t figured out how to target the precise interaction intended and can only hit the general area, drugs have many unintended side effects and untended interactions with the side effects of other drugs. Because the RANK receptor is present on Adrenal gland cells, there could be a undocumented connection, but we don’t know. Please see:

  4. On December 18, my dentist diagnosed me with ONJ (Osteonecrosis of the Jaw). I had had two side-by-side extractions of molars done in May 2015. Although Prolia had been entered into my medical history, the dentist did not give me a warning about the serious risks of ONJ when you are on Prolia and have invasive dentistry done. My surgery is in late January, unless they can fit me in sooner. There is no cure for ONJ, and it can cause facial disfigurement and even death. I am taking holistic measures (rinses, garlic, etc) and hoping for the best but the surgery is often unsuccessful. Please let my unfortunate experience be a cautionary tale about going on Prolia. Any suggestions would be much appreciated.

  5. My dentist describes it as a scraping away of the dead “tissue” (?) in the 1cm hole that I have in my upper left jaw. My condition is also know as “dead jaw”.

  6. I was uncomfortable with the prospect of having debridement done on my jaw, and asked my dentist for options. On January 29, I will have laser treatment instead of surgery.

  7. I was interested to read this. I have osteoporosis and was given an infusion of Aclasta 4 years ago here in Spain. I had a very bad reaction to it. My Dexa had deteriorated slightly at the end of 2017 and the rheumatologist prescribed Prolia. I have not taken it having read of the side effects. After reading your account I am now armed with more information when I go for my follow up next month!! Thank you

  8. I was given a first injection of Prolia in late Jan of this year 2018. My son and his family came in from the west coast and must have picked something up in the plane. It was a minor flu to them, runny nose in the children, etc. but they fault it off easily. I, “Granny” on the other hand became EXTREMELY sick the entire month of February after they went back. For 48 hrs. of that month, I KNOW and would swear on a stack of Bibles I was dying. I could not even roll over in my bed. I live alone and being so weak did not know what to do. If I called the ambulance to take me to the hospital, the police would have to break down the door and my home would have been wide open for looters and thieves for days. I just gave up and said the hel- with it, and laid their for two days drinking water from a bottle next to me I was so dehydrated with dry heaving. Prolia SUPPRESSES the immune system cells too !!!! I have read countless testimonials from other individuals that confirm my experience with that poison !!! ……………… I grew up in a family of medical research (Nobel level) and academia. Six doctors in the family (counting the ones who married into it) and 3 were Prof. of Med. at one of the best med schools in the US. One of them was internationally respected and taught me to care deeply about medicine., morally, ethically with integrity. “FIRST DO NO HARM !!!” I can not describe how DISCUSTED I am with the destruction of GOOD medicine ……………. my heart is broken and I will speak out until my last breath to bring back the profession of healing.

    1. Grace,
      Hoping you have completely recovered! Unfortunately, we see patients with unintended side effects of prescription drugs regularly – it is a very big problem, which is why we write about it. Suppressing the immune system is one of the many known side effects of Prolia. The problem is that Pharma only has the ability to make “sledgehammer drugs”, meaning they only have the ability to hit the general area like a sledgehammer, rather than the ability to target the very specific interaction needed, like with a finishing nail or thumbtack. That combined with the average of 10 year hundreds of millions of dollars drug approval process, which doesn’t allow any changes to the original formula submitted despite new information, means drugs are approved, knowing they cause a bevy of unintended side effects. And, when the side effects of one medication interact with the side effects of other medications in the system, the problem increases geometrically. Please see:

  9. Regenexx Team,
    Haven’t read yet the link you gave me, but will try to take the time. (Calif. son’s B-day, have to face time with the grands ;o)

    We, I, won’t know if I ever will “recover” from that toxin, will we ? These immunosuppressants are lethal in the end. It’s just a matter of time in each patient / victim. I have had two people close to me die who were on two different ones for two different diseases. One for MS was on hers for only a couple of months. Got a cold, went into pneumonia, put on life support and dead within a week. The other was the dearest step-mother one could have. Was a nurse, too. Hers was for arthritis. She was an amazing woman who was incredibly active into her 80s. Ended up in bed and died. Her son said her immune system gave out. WHY anyone would give an immunosuppressant to an older person whose T-cells are no longer reproducing as they once did anyway is without a conscience !!!

    Yes, the “system” of approval has GOT to CHANGE and be improved. GREED has taken over one of the noblest of professions, ie. medicine. The “process” of approval should be ongoing, introducing every new bit of info ASAP. Gee, that could not only save lives, but wasted money on a dangerous drug. Novel thought for today’s corrupt world. ………….. When little “moi” had a reaction to a fairly new drug back in my 20s, the M.D. who was treating me, granted, because of family connections we were referred to only the best, immediately wrote up my case in the NEJM or one of the more well known medical journals. WHY ?? To get the word out about the danger. Medicine actually cared about the patients.

    I’m glad someone referred me to this site. I will try to keep in touch.

  10. Interested in more info as to what you do for Osteoporosis! Just had second Prolia (6th month) injection! After reading above comment about how ill Grace was confirmed my thoughts that what caused me to be ill almost a month!( interestingly I was in Cayman)
    Now having deep muscle or bone pain! Not bad just annoying! Flying to Cayman on June (husband working there)
    Can anyone just have a consult with you?
    Thanks never wanted to do these injections but was made to feel I was a walking bone mess!

    1. Cheryl,
      Sure, you can, but more doable in Colorado. Generally speaking, Curcumin has been found to be especially good for bone health. It increases the formation of osteoblasts which are bone forming cells, and cuts down on the formation of osteoclasts, which are bone destroying cells. Please see: Many people have also found both the advanced stem cell support formula and glucosamine and chondroitin helpful for bone health.

  11. Thank you for setting up this very helpful and informative site, Chris. I had my 1st injection of Prolia in early October, 2017 and my 2nd in mid April,2018. On 28.12.2016, my bone remodelling marker, C-Telopeptide reading was 472; on 30.8.2017 330 and on 21.2.2018, 4 months and 18 days after going on Prolia it had dropped dramatically to 75. My endocrinologist had earlier told me the lower the figure, the better, and that if it was 600-700 he had to treat me.

    Within about 12 minutes of the first injection, I had side effects – tingles at the base of the two smallest fingers on my left hand. However, I persevered with the drug as I could live with the intermittent, usually short-lived pains at the top outer side of my left thigh and to a lesser extent my right thigh, the pain as soon as I started to walk uphill, sore areas on the outer sides above the ankles, sometimes as bad as ‘shin splits’ above the ankles, then pains on the outer sides of my knees and sometimes pain down the full length of the outer side of each leg from top of the thigh, down past the sides of the knees to the ankles. Less often there were general aches in the legs, odd tingles in the hands and some tingles/numbnesses in the legs. Then I started to get the odd pain in the right elbow, odd pain in the breast, the shoulder and the odd shooting pains like a lightning bolt through my right side – once down neck to groin and other times just through the torso. If these pains, about 3 of them, had been longlived, they would have been unbearable. The first time I thought I might have been about to have a stroke. My left leg doesn’t like taking my weight any more, for instance since about 29.3.2018, I have found it painful if not impossible to walk up stairs in the usual way but go up one step at a time with my good (right) leg and step up with my bad (left) leg beside it. Once I got the pain in my left leg when pushing a trolley around a supermarket and ended up limping. Driving home (in a righthand drive vehicle as I live in Australia) the pain got so bad in the whole of my left leg I had to reach down and loosen off my shoe and struggled to drive the next 6 km or so until it was safe to pull off. Wondering if I’d be able to make the other 25 km home, I vigorously massaged my lower left leg above the ankle and then with great care pulled back on the highway. No problems!

    In recent weeks when I sit at the computer, as I often do, I sometimes get sore across the tops of my thighs. I have had two very bad nights where aching legs stopped me from getting to sleep for about 90 minutes on 10.5.2018 and this morning for 100 minutes from about 2.50-4.30 am. Last night, 31.5.2018 I was sitting at the computer and felt my hamstring up behind my right thigh about to cramp, so stood up to walk around and stretch it. It was agonizing, and then my left hamstring went into spasm as well, and I had two tight cords sticking out the backs of my thighs. I slumped to the floor and I and then my husband tried to relax the muscles by massaging to relax them and ease the pain. No luck. As I’d had success with a heat bag on another occasion when I hadn’t been able to walk and put a heat bag on the tops of my thighs for two days, my husband ran to heat a heat bag up in the microwave while I bumped along on my bottom and lay in front of our electric fire to try to relieve the pain.

    After the first bad night I rang my endocrinologist. He said he had been treating women with Prolia for 10 years and never had one suffer from aching legs and that he did not believe my aching legs were caused by Prolia. However, I keep a detailed log of anything medical, including random pains, dates they occur, etc and I had belatedly referred to this log and typed up extracts showing all the new pains I had experienced since taking Prolia. It was only that they were no longer short-lived but numerous and longlasting and interfering with my lifestyle that had prompted me to produce them to show to him and my GPs. However, when I offered to email my log listing all my symptoms since going on Prolia to him, he did not want me to.
    I have no intention of continuing with this drug and he is happy for me not to, as are my two GPs. GP No1 ordered tests for Low Blood Calcium, Vitamin B12 and Vitamin D. All were okay.
    My dilemma is that the Prolia still has another 4 weeks, 17 days to run. Even worse, after reading your website, I find I am likely to start breaking bones again.
    Today my GP No2 referred me to a rheumatologist, which is what my endocrinologist had suggested, but I won’t be seeing him for three months. Meanwhile I am to take a Magnesium supplement on top of my Caltrate which includes a Magnesium supplement. I also bought a Magnesium spray to use directly on a cramp if I get one.

    If you have any comment on my Prolia history or can give me any advice, I would love to have it. Many thanks.

    1. Rosalie,
      We’d be glad to examine you, which would be necessary to offer specific advice. Generally speaking, curcumin is very good for bones as it increases the formation of osteoblasts which build bone, and cut down on osteoclasts which breakdown bone, so a net positive. Let us know if you would like to set up an exam.

    2. just read your letter and I could relate to your experience ++ received 3 prolia injections and experienced pain to legs when walking +lots of back pain (becoming worse); after a stressful move became someone who basically could not walk 2 steps without experiencing excrutiating pain … someone who could walk kms 1 year ago to needing ibuprofen etc… to mobilize. prior taking prolia I was asymptomatic and not aware of any bone density problems and active++, I believe this drug has many side effects and I will try another route.

  12. Thanks for your comments, Dr Chris. However, I am in Australia with no current plans to travel to the US so would be unable to make an appointment to see you. Please excuse several typos in my earlier comment,. The concerns I was hoping you would be able to address are:
    1. What can I do to minimize harm from the Prolia injection I had in mid April from continuing to release the drug into my system over the next four and a half months (not weeks as per the typo)? At this time, because I am on other medications as well as Prolia, I hesitate adding curcumin to the mix.
    2. How serious does my problem sound? For instance, should I treat it as a matter of urgency and get the earliest appointment I can with the rheumatologist even if it seriously interferes with other plans?

    1. Rosalie,
      As it says in the Blog, if you’re on Prolia, definitely consult your physician before getting off. The side effects of Prolia are concerning, and the side effects of stopping the drug are concerning…which is why we wrote about it. But unfortunately, not being able to examine you, there isn’t anything we can do to advise in your particular case.

  13. I’ve being o. Prolia about 4years I started stations 6 weeks ago and getting very bad muscle pain and loss of appetite is there’s connection

    1. Margaret,

      Prolia has some pretty nasty side effects, and much worse ones when the medication is stopped. We’d need to examine you to see what’s going on in your particular case.

  14. I had my first shot of Prolia May 2018. I had the worse side effects. Dryness! Itching; burning ( like a continuous sunburn). I can’t even stay out in the sun for a long period of time. My muscles are sore. I wake up like this everyday. Never again……….

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