Rhabdomyolysis Warning Added to Adderall, Other ADHD Drugs

Federal drug regulators have announced that new warnings will be added to Attention Deficit and Hyperactivity Disorder (ADHD) medications, such as Adderall, Concerta, Daytrana and Ritalin, indicating that the drugs may cause a severe form of muscle injury and kidney damage, known as rhabdomyolysis.

On May 13, the FDA Center for Drug Evaluation and Research approved safety labeling changes for ADHD drugs, to add rhabdomyolysis to the list of possible adverse reactions that may be caused by amphetamine-based medications. The warning comes as the drugs continue to be prescribed to children at increased rates.

Rhabdomyolysis is a side effect associated with several different types of medications, which causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream.

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Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism, however these drugs are prescribed heavily to children and young adults. Over time, rhabdomyolysis can lead to kidney damage and even kidney failure. Some may require dialysis or a kidney transplant.

The list of drugs that must now carry the rhabdomyolysis warning includes Adderall, Adderall XR, Concerta, Daytana, Desoxyn, Dexedrine, Focalin, Focalin XR, metadate CD, Methylin, Quillivant XR, Ritalin, Ritalin LA, Ritalin SR, Strattera and Vyvanse.

Concerns About ADHD Drug Overuse

The new FDA label warnings comes amid increasing concerns over the perceived overprescribing of ADHD drugs and their potential health risks.

In April, the U.S. Centers for Disease Control and Prevention (CDC) released the first national study on the treatment of ADHD in children. The CDC found that 40% of children diagnosed with ADHD were being treated with medication, compared to only 10% receiving therapy alone and only 30% receiving a combination of therapy and drug treatment. About 10% received no treatment at all while another 10% were treated with dietary supplements alone.

Another study, published in July 2014 by Danish researchers, found that children taking Ritalin, Dexedrine, Concerta and other amphetamines for ADHD showed increased rates of hypertension, heart disease, and arrhythmias, among other heart problems. Their findings indicated a dose-specific response between ADHD drug use and cardiovascular problems.

About 15% of all high school-age children in the United States have been diagnosed with ADHD, but some experts say that number should be closer to 5%.

One early advocate of stimulate treatment for children with ADHD, Dr. Keith Conners of Duke University, said that the rate of children now being diagnosed with ADHD and placed on drug treatments is “preposterous” and called ADHD an epidemic manufactured by drug companies.

Conners and others say that the inflated diagnoses and prescriptions are the result of a 20 year effort by the pharmaceutical industry to cash in on concerned parents hoping that poor grades and typical childhood behavior can be cured with drugs.

While some manufacturers paid off doctors to speak on their drugs behalf, others have gone as far as releasing comic books encouraging children to take medication to address ADHD. At some point since 2000, Conners noted that the FDA has cited every major ADHD drug manufacturer for false and misleading advertising about their ADHD drugs.

Those efforts led to $9 billion in sales for the ADHD drug industry in 2012, and 3.5 million children using ADHD medications.

16 Comments

  • TorySeptember 18, 2023 at 2:55 pm

    I've been taking Adderall for ADHD on and off for the past 17 years. Starting about that time, I've had more than 14 kidney stones with ER documentation. This including a 4-day hospitalization including an emergency stone removal & stent placement. I had a hole in my kidney resulting from blockage pressure. I just recovered from a 2mm a few days ago. I have 2 other 2mm stones waiting to drop. I'll[Show More]I've been taking Adderall for ADHD on and off for the past 17 years. Starting about that time, I've had more than 14 kidney stones with ER documentation. This including a 4-day hospitalization including an emergency stone removal & stent placement. I had a hole in my kidney resulting from blockage pressure. I just recovered from a 2mm a few days ago. I have 2 other 2mm stones waiting to drop. I'll be looking into this because prior to reading above, I had no advisory that there was a connection. My urine/ blood returned today with high creatinine and albumin aka related to blood protein filtration in the kidneys. I also have high blood pressure, am not overweight, and active.

  • ShemekiaSeptember 13, 2023 at 11:55 am

    My son was placed on Adderal a few years ago. At the time he was 10 years old. He had to be hospitalized for a week for renal failure. Since the first episode he’s been ICU bond 2-3 times a year for weeks in. He was diagnosed with renal disease non specific. I had no clue of the side effects and what has the issues with my once Healthy baby boy. His caring physician lowered the dosage and he cont[Show More]My son was placed on Adderal a few years ago. At the time he was 10 years old. He had to be hospitalized for a week for renal failure. Since the first episode he’s been ICU bond 2-3 times a year for weeks in. He was diagnosed with renal disease non specific. I had no clue of the side effects and what has the issues with my once Healthy baby boy. His caring physician lowered the dosage and he continued to take the medication. She had use to take labs and she planned to monitor him. Not once mentioning the reason for his kidney problems. I trusted my child’s life at other individuals discretion. It took me a while to research and behold my son has suffered many side effects even problems with his muscles. No one never mentioned the cause. My son has since been hospitalized twice a year with no diagnosis but renal disease. After being on the medication for 2 years he’s since discontinued the Adderal. He has kidney scarring with a 30% functioning kidney. It’s devastating and exhausting to watch my now 15 year old son suffer from the long term side effects from a medication that has nearly killed him. I feel the community has no voice and the long term effects has been dismissed. A living nightmare

  • AndrewDecember 19, 2022 at 5:28 am

    I have been on amphetamine salts the majority of my life, since 7th grade and I am now 36. Yes I have symptoms of kidney issues, i.e. flank pain, trouble urinating, etc... but the worst effect of adderall prescription is the effect it has ... in , as the leaflet puts it "MAY CAUSE ABNORMAL DRUG SEEKING BEHAVIOUR" - unfortunately for me this side effect was well entrenched in myself by the time I n[Show More]I have been on amphetamine salts the majority of my life, since 7th grade and I am now 36. Yes I have symptoms of kidney issues, i.e. flank pain, trouble urinating, etc... but the worst effect of adderall prescription is the effect it has ... in , as the leaflet puts it "MAY CAUSE ABNORMAL DRUG SEEKING BEHAVIOUR" - unfortunately for me this side effect was well entrenched in myself by the time I noticed the additional side effect warning added to the leaflet.

  • ReginaSeptember 21, 2021 at 4:18 pm

    My son has been affected after years of taking these meds at age 22 he has kidney failure.

  • CaptnJuly 29, 2021 at 1:46 pm

    Tony- same here. On adderall for ADHD for about 3 years, no previous issues or family history of kidney stones. Had 1 stone on each side, was able to study the stones to find out they are high in oxalate. (Most miserable time in my life passing the stones) That means tea, coffee, chocolate, vinegar and cider are not good for your kidneys. I highly recommend working out, strength training and a [Show More]Tony- same here. On adderall for ADHD for about 3 years, no previous issues or family history of kidney stones. Had 1 stone on each side, was able to study the stones to find out they are high in oxalate. (Most miserable time in my life passing the stones) That means tea, coffee, chocolate, vinegar and cider are not good for your kidneys. I highly recommend working out, strength training and a very high intake of water. I now take adderall 5 Mg every other day and one cup of coffee every other day.

  • TonyApril 5, 2021 at 5:34 am

    I started concerta 18mg for adhd related issues of the inattentive/distracted and impulsivity spectrum; (I'm not hyperactive) and then went up in dose to 27mg where I remained for 8 months. I felt more inclined to drink coffee and very little water as I'd always usually go for the stimulant on top of the medication, just I never had such a drive or desire to drink coffee. I drank it all day and ev[Show More]I started concerta 18mg for adhd related issues of the inattentive/distracted and impulsivity spectrum; (I'm not hyperactive) and then went up in dose to 27mg where I remained for 8 months. I felt more inclined to drink coffee and very little water as I'd always usually go for the stimulant on top of the medication, just I never had such a drive or desire to drink coffee. I drank it all day and everyday until one evening I woke to a sharp pain to the right flank. I went to urinate and observed blood in my urine. I scheduled an appointment with my GM and he also found blood in my urine. Long story short,it was found that I had a kidney stone. 5 months later, (September 2020 till approx December) I was back on concerta, in about January.. And ffwd to now, I'm having pains again on the same right side.. I'm kinda panicking!! I don't wnt to live through this hell again! Has anybody else had similar condition of kidney stones forming (with no prior kidney health related issues) prior to taking Concerta? I'd like to think it's coincidental, however this time around I'm rarely drinking any caffeine, and I'm drinking plenty of herbal teas and water with Apple Cider Vinegar! What could this pain or kidney stone be related to really? Is concerta the culprit? I read that certain mushrooms can aid in similar ways with the adhd symptoms we experience. Worth a shot if in fact my concerta is causing kidney issues. Any thoughts ?

  • MillieJanuary 18, 2021 at 5:39 am

    I agree rich well said. Curious about this, I just started my own prescription of vyvanse at 10mg and I don’t even take it everyday but I already feel some pain in my kidney area so keeping an eye on it

  • RichJanuary 13, 2021 at 1:34 pm

    Ok, so here goes. I know this is an older thread but it still needs to be addressed. I am 36 yrs old I was diagnosed at 15 years of age. When I was diagnosed the Drs. Started me on Ritalin then moved me to Concerta. Once I was transferred over to Concerta I balanced out and it helped me to get a handle on my life. I firmly believe that if the Dr. Is monitoring the patient the way they are suppose[Show More]Ok, so here goes. I know this is an older thread but it still needs to be addressed. I am 36 yrs old I was diagnosed at 15 years of age. When I was diagnosed the Drs. Started me on Ritalin then moved me to Concerta. Once I was transferred over to Concerta I balanced out and it helped me to get a handle on my life. I firmly believe that if the Dr. Is monitoring the patient the way they are supposed to then the risk is minimal. Like any medicine out there there are risks for certain people. Basically long and short please please don't misplace blame. Without this medication I would not be able to hold a job or a relationship. I paused on my medication for a year. I lost an 8 year relationship and a good job. At the end before I reached back out to receive treatment again it got so bad that I physically could not perform in the bedroom and that includes solo. I later discovered it wasn't a physical problem with my body but an attention issue. I couldn't be in that moment because my mind was running wild and wasn't filtering the dozens of random unapplicable thoughts. It was a nightmare all around. Like I said prior, I know there are ppl who have had some bad results most likely due to bad Drs. Unfortunately there's a learning curve for everything so try to keep an open opinion. Be cautious and get information make an educated decision but don't condemn something that helps so many.

  • AlisonJuly 20, 2020 at 12:41 am

    I was on both medications Ritalin and Concerta I had many muscle pains, tachycardia, shortness of breath, and muscle spasms in my scalp at 14 I was diagnosed with stage 1 kidney disease (FSGS) I'm saddened and frustrated to read all your comments and I'm sorry you have these health problems now, I truly hope children these days are not among the victims of these medicines.

  • JaneMarch 8, 2020 at 4:29 am

    So my name is Jane and I wanted to get some answers. I have been on Adderall for over 7 years. I recently had some side affects. I thought I had diverticulitis and they sent me to see the GI Doctor and they took MRI and the results were no diverticulitis but I had renal cyst and my doctor said I was fine. I started crying because I know I wasn't fine. My psychiatrist put me on a higher does. I rec[Show More]So my name is Jane and I wanted to get some answers. I have been on Adderall for over 7 years. I recently had some side affects. I thought I had diverticulitis and they sent me to see the GI Doctor and they took MRI and the results were no diverticulitis but I had renal cyst and my doctor said I was fine. I started crying because I know I wasn't fine. My psychiatrist put me on a higher does. I recently moved back by my parents but since I got the results. I had symptoms such as swelling in my feet, ankles and leg. My feet would turn purple and my hands. My skin was dry. I went to my family doctor to get a second opinion for my results. So he dropped a blood test and he called me and told me my kidney were running slow and needed a ultrasound sound. Anyone experience scratching of the sculp and I have lesions and painful sore on my sculp, face and back and shoulders? Anyone had Acute renal failure? Kidney cysit ?

  • CarolFebruary 28, 2020 at 5:17 pm

    Was prescribed adderall for 12 years and went off 7 months ago after reading how bad it is for you but unfortunately I have serious wounds on my legs from itchiness and realize my condition is most likely from years of taking this dangerous drug. Why did my doctor (pharmacologist/ psychiatrist keep me on this medication for So long?! Surely he must have known the dangers! I was treated twice for C[Show More]Was prescribed adderall for 12 years and went off 7 months ago after reading how bad it is for you but unfortunately I have serious wounds on my legs from itchiness and realize my condition is most likely from years of taking this dangerous drug. Why did my doctor (pharmacologist/ psychiatrist keep me on this medication for So long?! Surely he must have known the dangers! I was treated twice for Cellulitus 3 years ago in the ER and now think it was to do with adderall, legs had swelled up so bad I could hardly walk! Scared to death now because I’m having symptoms of kidney problems! Adderall is a toxic drug! Wish I never took it!

  • BertNovember 23, 2019 at 3:06 pm

    I take Adderall for adhd, and I found that it works really well for depression that is associated with Adhd. Adhd is caused by a Dopamine deficiency, Dopamine is 1 of 3 hormones your brain makes for reward and pleasure. When you take Adderall you need to drink plenty of water.

  • VirginiaAugust 7, 2019 at 11:03 pm

    Our son, 29, is on Adderall for depression (he has never been formally diagnosed with ADHD) by his psychiatrist. He has developed protein in his urine and has a Creatinine of 1.7. He also takes Vyvanse and other meds prescribed by this Dr. I am in fear for his health. As his mom and myself a kidney transplant survivor. I am painfully aware of the dire ramifications of kidney failure. He is awa[Show More]Our son, 29, is on Adderall for depression (he has never been formally diagnosed with ADHD) by his psychiatrist. He has developed protein in his urine and has a Creatinine of 1.7. He also takes Vyvanse and other meds prescribed by this Dr. I am in fear for his health. As his mom and myself a kidney transplant survivor. I am painfully aware of the dire ramifications of kidney failure. He is aware but does not want/refuses to stop taking this drug. Is the Dr. correct to keep him on this amphetamine for depression?

  • DebJuly 22, 2017 at 5:43 pm

    I just found out I have third stage chronic kidney disease these drugs have been prescribed to me for years

  • JImOctober 5, 2016 at 8:48 pm

    Stop taking dangerous drugs like Adderal! Don't be a junkie..

  • JanetApril 2, 2016 at 8:35 am

    I'm 55 and have been on Adderal or Ritalin for several years. I was hospitalized for 4 days with Rhabdo after completing some very light workouts. Now I'm told that I have to be extra careful, and minimize strength training. I still don't feel well, dizzy and extremely weak. Does this risk fade with time? I want my weight training back!

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