Daytrana Patch Problems Exceed Reports With All Other Drugs

  • Written by: Irvin Jackson

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The attention deficit and hyperactivity disorder (ADHD) treatment patch, Daytrana, has received a surprising number of adverse event reports, outpacing every other drug on the market due to medication errors and potential side effects, according to a new report. 

In the latest issue of the Institute for Safe Medication Practices (ISMP) QuarterWatch report (PDF), which analyzed all adverse events submitted to the FDA over the second quarter of 2012, Daytrana patch problems were identified in more than 1,000 cases involving young children, with a median age of 9 years old.

According to the report, adverse events associated with Daytrana over the four calendar quarters ending in the second quarter of 2012, exceeded those associated with any other drug monitored by the group. GlaxoSmithKline’s Advair Diskus asthma inhaler was associated with the second highest number of reports, followed by Johnson & Johnson’s Duragesic-100 fentanyl patch.

Out of all of the ADHD medications on the market, Daytrana accounts for only 3% of sales, but 99% of the complaints received by the FDA, leading ISMP reviewers to suggest that the FDA should consider issuing a Daytrana recall.

“We do not see a useful role in clinical practice for a patch product that has been plagued by manufacturing problems for the entire six years since approval,” the report concludes. “It has no proven clinical advantage over the oral tablets, causes irritation and skin rashes, and has a slower onset of action than extended release methylphenidate.”

Defective Adhesive, Skin Problems and Involuntary Movements

In most cases, parents complained that the adhesive patch did not come off correctly, which can lead to problems sticking the patch to a child and uneven absorption of the medication, methylphenidate. However, many of the complaints also suggested children were suffering potentially serious side effects of Daytrana.

Complaints included children suffering erythema, irritation, rashes, pruritus, burns, erosions, swelling vesicles, urticaria, and involuntary muscle movements. At least one case resulted in severe injury and hospitalization.

About half of the Daytrona problems identified were linked to drug administration problems, with many parents indicating that problems removing the adhesive backing led to the patch falling off or causing trouble with applying it to their child. There were also 89 cases of drug prescribing error.

The cases of involuntary movements were of particular concern, as in clinical trials there was at least one case where the child’s involuntary movements never resolved. The involuntary movements, often referred to as tardive dyskinesia, are a common complaint among some stimulants, but the ISMP report notes that health experts at the FDA are concerned that Daytrana tardive dyskinesia symptoms seem to appear more often than with other ADHD drugs.

The complaints are nothing new for Daytrana. The first distributor, Dublin, Ireland-based Shire, gave up on the product in 2010, after 10 Daytrana recalls were issued since it was first approved in the United States in 2006. The patch’s distribution was taken over directly by Noven Pharmaceuticals, which has issued two recalls since then, one in March 2011 and another in September 2011. The problems with the adhesive being stuck to the protective liner was frequently the cause of the recalls.

QuarterWatch estimates there were 3.9 million prescriptions for Daytrana in the second quarter of 2012 alone.

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  1. golds Reply

    the “problems” causing recall issuance are ridiculous. I have so much trouble getting my patch refilled because of useless recalls like this. This is the only ADHD medication that has really worked for me throughout the whole day without causing insomnia. The extended release pills don’t last more than 5 hours, and I need it to last much longer than that. In addition, daytrana feels more natural as the rise and drop of the medication are more gradual, where as the pills cause jagged ups and downs, and this making me feel worse and irritable. Leave this drug alone!

  2. jennifer Reply

    i absolutly agee this is the only medication that has worked for my son age 8 he had a real hard time in school in kindergarden and then in 1st grade so we had to hold him back a year now in 1st grade again this year he is a straight A student and he is so happy in the mornings and throught the day without the daytrana my child would not have a chance in school or out! SO PLZ LEAVE DAYTRANA ALONE!

  3. Amy Reply

    My daughter has also been on Daytrana for number of years. We give her breaks, as recommended by her doctor. She has done very well. Like the prior post, she was held back in first grade. She is now entering HS and left middle school with a solid 3.7 average.

  4. Tammy Reply

    My 8 year old grandson just started Daytrana and I was just wondering how long takes for the patch to start working like it should.We had alot of trouble with school cause he dont want to sit down and do his work or anything.At my wits end

  5. Andy Reply

    SO far this patch has yielded the best results for our 8 year old son. It takes an about 1.5 hrs to take affect and does suppress his appetite to the point where he will not eat anything. Without it, there is no way he could attend normal classroom. the patch leaves a bright red mark for several hours after removal and we have to treat his skin to lessen the adverse affect of the patch. We try to go without on the weekends to give him a break and to check his behavior without medicine. About the only time he eats is when he’s off the patch. He’s 30 percentile on weight and 50% on height so it could be worse.

  6. Karla Reply

    Thank you all so much for your comments! My son (8yo) has been on this medication for 1 month. we have have not noticed any side effects and after reading the recall info, I began to worry. I am going to refill his prescription and just continue to pray that he continues to do well with the medication

  7. Rachel Reply

    my daughter age 7 has been on the daytrana patch 10mg since may2013 and only issue ive had is the red blotches after we remove it after school and one of my boxes were sticking to the protective liner,but it was exchaged,otherwise no serious side effect except the redness like i said.She has been doing great in school and she come home does her home work like a pro ,it has def helped her.

  8. Kelly Reply

    We tried many and have been using Daytrana ecuslivley for about 5 years now and could not be more pleased. We apply patches 1.5 hours before wake up time

  9. Amber Reply

    My daughter as well started this patch in the first grade after a very rough Kindergarden. She absolulty will not take any pills by mouth. Thankfully we have now been on the 10mg Daytrana patch for over a year now and this year She made the honor roll!! Yes her skin is red after we remove it but so is a bandaid when you remove it after being on for so many hours. I am more than happy with this product and wouldn’t know what to do if they stopped making it.

  10. Kenyata Reply

    My 8 year old son , then 7, had a reaction to Daytrana. He said there were spiders crawling all over him. He was having hallucinations. I had to rush him to the hospital to see what was going on with him. The first dose prescribed worked fine but after a few months he went back to his old self while on the patch so the Dr. increased the dose. I didn\’t know that Daytrana is just ritilin in a patch form. I would have never given it to him had I known. I\’m glad they recalled it.

  11. karyl Reply

    I am an adult on daytrana it has helped me very much. My ability to focus, pay attention, and stay on task is wonderful.I would be devastated if this medication is recalled and not made anymore. I have very few side effects and am very happy with the results

  12. Chandra Reply

    My son is in the 8th grade with A’s and B’s prior to Daytrana . He has had trouble staying focused in class since elementary as well as problems with teachers and making friends. He started taking Daytrana 10 mg before Christmas 2013 and I quickly saw an improvement in his organization and focus which in turn will help with his confidence around his peers.

    All of a sudden I am having a problem getting a refill on the prescription. I need to find a pharmacy that can consistently fill the order.

  13. Amy Reply

    My 9 year old son has been on Daytrana for over 2 years. He has been doing extremely well now at school and home because of it. It has helped him so much and if it is ever recalled for good I don’t know what we will do. He does have a red mark on the area when removed and a few times it got extremely itchy where it was stuck to but once we removed it and placed one in a different spot he was fine. Like all stimulants his appetite is poor on it but about an hour after it is removed he is starved and eats all evening.

    The only problem we have had is that it takes at least 3 hours to work for him, it is almost like clockwork that at the 3rd hour it is on it seems like a switch inside him is turned on and it is working. To get around this I set an alarm at 3:45am every night and get up to put his patch on and I go back to bed. This way when he gets his bus at 7:10 the patch is working well and he is under control for the bus ride and then at school. He had some sensory issues and cannot swallow pills so daytrana is absolutely necessary for him.

  14. BRANDY F. Reply


  15. CS Reply

    Our son was on Daytrana for 2 years and did wonderful! We decided to increase the dose due to his growth and weight change but he didn’t like the higher dose, 20mg. So we then tried Concerta, he didn’t do well with that so we are now wanting to try 10mg of Daytrana again because it worked so well before. The only side effects we noticed was a slight redness to the area where the patch had been removed but it would clear up over a couple of hours. Concerta caused some emotional issues that we didn’t have with Daytrana so I hope they don’t take it off the market. It works so that there is no jarring come down effect like with some if the other stimulants, like Ritalin.

  16. Kim Reply

    My 9 year old autistic son had a problem focusing in school, he has been on the patch since he was 5. Dad and I are very pleased with the results. He moved out of the autism classroom unto an inclusion class with larger class size of students. I am very pleased with this medication and his Doctor.

  17. Tracies Reply

    My son cannot swallow pills and this patch has been working fine for him. We just started taking it last fall and now it’s been recalled. I am really upset about this. The pluses out weight the minuses in my sons case. I hope something similar will take it’s place. Please find something.

  18. Katie Reply

    I use daytrana and am sooooo upset I can not fill my prescription now. It helps me and nothing else works.

    So upset

  19. anonymous Reply

    This is the only thing that has worked for my child. He tried the pill at the same dose and they made him go off the wall. His metabolism is also to fast for oral meds. Bring it back but lower the outrageous cost. After he started the patch he could concentrate in school and got the highest good awards everyday.

  20. cheryl Reply

    My son has been on the patch for 9 years now and it is a God sent !!!! He cant swallow pills . So the patch is great ! He started in 3rd grade and is now going into his junior year of high school . I give him a break on weekends and during the summer. His is 6 foot tall and 195 lbs. It has not effected his growth at all. my husband and I are both 5 ‘ 9″ so we are very pleased to see he is taller than us. I put it on him about 1 and 1/2 before he needs to be up. I also take food to him at that time. He is still very sleepy but I get him to eat in bed. Then he wakes up ready to go !!! I don’t have to fight with him AT ALL !!! He stays at a even dose all day long . No ups and downs like the time released pill he tried first. We used to put it in a spoon full of pudding. He has always said to me; “I don’t know why you make me wear these, they don’t do anything.” LOL yes they do. We are all different and we all need different things that is what makes the world go round. If it doesn’t work for your child keep searching until you find what is right for your child . I give God thanks and praise for this patch. Thanks Cheryl

  21. Amy Reply

    My 7 year old son has been on Daytrana for almost a year now. This patch is the best thing for him! He has been on almost every type of ADHD pill available. Nothing worked well for him because of the severe mood swings. Also, his stomach was getting torn up from the pills. This patch has helped him in school – was C/D student before, now straight A student & accepted into gifted ans talented program. Now, I’m having somuch trouble finding his medicine & school starts in 2 days! Please leave this medicine alone – some of our kids really need it! If it doesn’t work for your child, just switch to something else, like the rest of us have done in the past. PLEASE LEAVE THIS PATCH ALONE – MY SON NEEDS HIS MEDICINE!

  22. Tamisha Reply

    My daughter has been on the daytrana patch since March and it has worked well for her no side effects. Please put the patch back on the shelves. Thank you!!

  23. Maria Reply

    My son whom I love very much needs this patch. He is above average in his class and if not for this patch He would be no where near it. He had a few ticks, like constantly clearing his throat, also redness at the patch site. However, my son is a blessing and so is this patch. Tried a few other medications first and none lasted long enough or made him feel “Normal”! I beg you please do not take this from him. He is a beautiful person, and this helps him be able to control his actions.

  24. Joann Reply

    My son has been on Daytrona for two years now. The other ADHD medicines made his zombie like, couldn’t sleep, extremely introverted and low self esteem. Daytrona was a miracle for him. He never had any red where the patch was placed. The only side effect we noticed is when the medicine is wearing off…he gets angry and yells for about a half an hour. Now I am noticing he blinks his eyes alot. (think this is a side effect) Now he is telling me since he started a new patch from a new box, he is sweating alot. (another side effect) Due to all the recalls, I am concerned. This has been a miracle drug for him along with another medication. He is doing very well, not sure why Daytrona is always being recalled. I

  25. WakeMeUp Reply

    I am an adult female, diagnosed with narcolepsy 20 yrars ago, on Daytrana patch the past couple of years, with methylphenidate twice daily to supplement. This combo is more effective for me than previous medications. I can work and drive safely.

  26. miles Reply

    well this daytrona is stupid, and very very abusive mentally, internally, and can damage every throught process and is dangrous, i take daytrona but have trouble telling hte doctors, and people who can help me, but i also live with my parents, and they think nothing is wrong, but this medication is abusive and can and has inflected harm mentally. now i know that i may sound crazy but it’s scarey and there is no way to get out of the mentall abuse that this patch has done to me, it ruined my life both phycologically and has gone so far that i even told myself; qoute on quote; this is not the medication to be on, it is very abusive, i need to get off of this medication becuase know one (except me) has tryed to do anything about it, i might be scared to tell them (doctors, and experts) about hte mentall harm it has done to me, i constantly tick, move move my head back and fourth and am to the point of being done with this “shit” (mind my language, you would do the same if you were mentally abused and had know way out of it, and were ignored because you were so mad that you could’nt tell anyone about the life or death problems, i’m am afraid and tired of this it does it at random times and i am scared of this medication, i have witnessed serious problems with tyhe daytrona patch 30 mg, it needs to be reported more so; shut down. please someone i’m am to the breaking point , it has torn me apart form my family in so many ways, and i want ot telll them the truth about all of this, please don’t say that i am making all of this up.

    the things it does:

    sexuall abust (to me)
    very strong ticks
    dangrous aftermath (after coming off from basically being high, i expirence Mood swings, anger, and face the reallity of what the shit did to my life

    to anyone reading this:

    i’m sorry if i am scarying you, but htis is the reallity of what anger, and expirence, misunderstanding one’s problems

    i wish this medication did’nt exist i would go back ot concerata in a heartbeat compared to a daytrona patch


  27. Matt Reply

    I was on the 30 mg Daytrana for 3 years, as an adult and my insurance stopped covering it. I have taken every ADHD medication, including desoxyn AKA methamphetamine and I am seeing a new doctor and said straight up, the patch is the only form of ADHD medication I am willing to take. I don’t want to take oral meds again. I did much better on these than any of the other meds. Slap it on in the AM and take it off a couple of hours before bed. Works better than anything else.

  28. Heather Reply

    Best thing ever for my son, he is able to do great in school. It does wonders, totally different person on it. Please do not discontinue Daytrana.

  29. Monika Reply

    Daytrana has been a lifesaver!! Before the patch we tried several different forms & types of pills. My son can’t swallow pills. He gags on the mixed crushed pills. Getting liquid is just as hard. I have recommended Daytrana to SO many people because it’s had such a positive impact on our lives. Now we just can’t get them to stay on his skin. It goes on in the morning before school & by early afternoon it’s off. This only leaves me the choice of getting myself upset with a very active little boy or trying to get medicine in him to help get thru homework times. Daytrana is what we’ve waited for, finally found it & now suddenly it’s not sticking. We don’t know what to do but this is the best thing for ADHD people.

  30. Natasha Reply

    My daughter has been on Daytrana for over a year now. It has helped her so much. She can not swallow tablets. Trying to get hold of the patches is an absolute mission. Today I visited 10 different pharmacies before I found it. Please make it easier for parents to get hold 9f the patches.

  31. Nilda Reply

    This medication has been AMAZING for my son. It’s a shame that the FDA threatens to take it off the market because of the medication sticking to other side of the patch. This is a ridiculous reason to take it off the market. My son has used others medications and he been acting very odd. I was so upset that I called the Daytrana makers and they told me they have recently put it back in the market. Thank GOD.

  32. Jill Reply

    My 14 yo has been on daytrana for 3 years. Its been a lifesaver for him and for the rest of our family. He tried several of other adhd meds but they all left him with massive mood swings when the drug wore off and it would create a rebound withdrawal affect. He would be so agitated he would act out. My son has made honor roll ever semester since he started daytrana. He lives a normal life, has friends, plays sports and gets to be in control of his thoughts and actions which gives him self worth. I am extremely grateful for Daytrana.

  33. Sue Reply

    I am an adult on Daytrona and just went to fill my prescription and can’t find it anywhere I am so upset Last month it was on back order and I did receive it before my old pack ran out but now I’m a wreck because I don’t know what I’m going to do. Daytrona is the 4 medication I have tried for my ADHD and Daytrona was the best medication for me. It has made such a difference in my life mostly in my work. I don’t know what I will do if I can’t get it filled within a week.. pray for it to be back on the market very soon

  34. Tammy Reply

    My son has been on the Daytrana Patch 15mg since May 2015, he has been off his patch for 1 month now because the pharmacy cannot seem to get it in. I have called his insurance company and asked for help and even called Daytrana and told them this is a serious issue. We still cannot get the patch. The doctor as of a week ago put my 8 year old son on Quillivant XR. He has been on Quillivant for 4 days now. So frustrating. I hope we can get the patch in again soon.

  35. Elisabeth Reply

    We love the product and had problems with it sticking to the plastic but when I get it on my son it is the best thing ever. I just went to get it refilled and know they target can’t get it and I feel helpless because I know this works for us and the pill he has trouble with. I took a second job to help pay the cast of the med because it was not covered by are insurance but I would do anything to help my son this is what works and the new stuff has so many side effects I am not sure what to do….Help

  36. Pascha Reply

    Both my 8 yr old daughter and 12 yr old son were on Daytrana (15mg and 30mg respectively). The product was AMAZING and the problem with the adhesive sticking to the liner was nothing more than minor inconvenience when you’re running late. My son has been off meds for 3 months and my daughter for about 3 weeks because we cannot get the prescriptions refilled anywhere. They are both struggling in school and extracurricular activities from not being able to focus. Please make this accessible again! The side effects and dependency problems from traditional ADHD medication are not something I want to subject my children to.

  37. Shannon Reply

    Please make the daytrana patch available again as soon as possible. My son is 9 years old and has been on Daytrana patch for 2 years. He has done very well with it and is an honor roll student. He does not like trying to swallow the pills and I like being able to control taking it off when he does not need it all day. Please please please make it available again. I have not had any problems with peeling the cover off. Thank u.

  38. Shannon Reply

    Please make the daytrana patch available again as soon as possible. My son is 9 years old and has been on Daytrana patch for 2 years. He has done very well with it and is an honor roll student. He does not like trying to swallow the pills and I like being able to control taking it off when he does not need it all day. Please please please make it available again. I have not had any problems with peeling the cover off. Thank u.

  39. Kelly Reply

    I echo the comments of everyone else on here. My 12 year old has been on Daytrana for over two years. It is the only medication that we have been able to find that does not have terrible side effects. I have not been able to find it anywhere and am desperate to get him the medication he needs. Do the manufacturers understand what this does to the quality of their patient’s lives? He is not able to concentrate at school, his grades are plummeting and he is in trouble all the time. PLEASE make these patches available again soon!

  40. Gary Reply

    The Daytrana patch has been a true blessing for my 11 year old son. Fourth grade was a horrible experience in the public school system. With a month left in school we were introduce to Daytrana (“Personality in a Patch”). My son is in now in 6th grade, with a straight A average, active in Boy Scouts, lots of friends, respectful, responsible, and focused. I am horrified at the prospect of loosing all that he’s gained. PLEASE DON’T STOP PRDUCTION!!!

  41. Amy Reply

    My son has been on Daytrana for 10 years and it is the only thing that works for him. Daytrana has been a major player in his developmental success socially and academically. We CAN NOT go back to the trail and error phase of our treatment to find a new medication. My happy go luck child turned into a defiant monster on all of the other medication we tried. It was a very long journey for our family to find a medication that worked with his chemistry,not to mention 10 years ago I could put a unruly 6 year old in a fireman’s hold if the medication didn’t work. I can’t do that with my now 6′ 3″ 16 year old. Please we need Daytrana to stay in production.

  42. Dennis Reply

    Want another piece of anecdotal evidence on it’s effectiveness. Fall semester of last yr. my 19 yr old son attended a local community college taking 3 courses, one of which was an entry engineering class. Had a 3.1 GPA. Effective 1/1/16, BCBS changed the formulary. That, combined with the shortage, effectively forced him to try 3 different alternatives. After 3 months, he had to drop out of all 4 classes he was taking because he was failing in every one.

    Seems pretty obvious to me that despite the problems, for some people it is a godsend, giving them hope of leading a somewhat normal life. That’s the value of having a stable of different drugs to treat the same problem. Every medication has the potential to affect different people differently.

  43. Cyndee Reply

    My son has been on the Daytrana Patch 30mg for several years. It was the only med that worked for his ADHD. He is going to be a Senior in High School this year. For those that have problems with children eating to keep weight on we let our son eat when ever he gets hungry it could 9:30 to 10:30 at night. i did not want him to have a growth hormone. Our MD told us to let him eat whatever he wanted and when ever. Sometimes he has ice cream for breakfast. He is the right weight and he is 5’8″. We rotate the site of the patch on his buttocks and have never had a problem. The only problem we have is when the patch is recalled.

  44. Andrew Reply

    My Adult Attention Deficit Disorder was not diagnosed until I was in my early 20s. I am 44 now. I have been on the patch since it was approved in the United States. It is the smoothest application of methylphenidate I have ever been on. It is my quality of life medication. I find it harder to get my scripts filled as there is less of it to go around. Yes I have had issues with the adhesives. Make sure skin is clean and rotate application site-no problem. I dread having to revert to taking oral medication.

  45. Cassandra Reply

    Daytrana is the only medication that has worked for my son. I spend 20+ hours each month trying to find the medication; going to/from the peds office to get new scripts/getting prior auths for new combos (2 15 mg patchs) because of the shortage. Using coconut oil to remove the patch & for skin care will take care of skin issues. PLEASE increase production and get more out there!!! None of the pills work for him because of his fast metabolism! He has very minor side effects from the patch: increase chewing of fingernails, anorexia, etc. This medication is a life saver for both him & me! He went from being almost suicidal because of people making fun of him in KG to being popular and straight A student in 2nd grade. No, it’s not all the medication but it makes a huge difference. These shortages are criminal!

  46. Stacey Reply

    My son has off the chart ADHD. He was diagnosed at five when he started school, though I knew that was probably what he had since he was too. During that first year, we tried four different medications and finally found Daytrana. He has been on it for nearly 4 years now and it it works so well for him. Two years ago, our insurance stopped covering it, even though he had been on it for two years. At that time, we tried another extended delivery type medication. The results were terrible. Since he’s been diagnosed, Daytona has been the only medication that has consistently worked for him so we have been paying cash for it since then. Every month it’s ranged between $225-$350.

    Starting in October 2015 it’s been harder and harder to find his prescription each month. Every time we would check into it the company would say The shortage would be resolved by the next quarter or in the next month or two. So far, that has not happened. As of today, July 2016, I am unable to locate it anywhere. I have literally called 30 pharmacies within a radius of 50 miles of our house and everyone is saying the same thing, their wholesalers or their suppliers are unable to get it and they don’t know when they can.

    I can’t even begin to fathom how this keeps happening month after month after month. If I could find an alternative medication that works on his symptoms as well as this does, I’d take it in a heartbeat. But that hasn’t happened and there’s nothing else out there that works this well for my child. I’m at my wits end, I have no idea what to do now.

    I furred everything from drug shortage, to recall, to shipping issues. I just want real answers.

  47. C Reply

    My thoughts are the same as all the parents. My daughter has tried every other drug available. They all created severe side traumas. Daytranna was the only one that has worked. She has been on it for years.
    What does it take for someone to listen.I was told the 3rd quarter was when the drug would be available> Well, it’s the 3rd quarter of the year? I have written to the Company without any replies.
    Her Dr. is stumped as the what to give her since we have been through this before, So, we are going backwards with the same druge previously taken and might I add with the same results.
    So, the end result is that u are taking her life away from her.

  48. Dianna Reply

    We tried almost EVERY available ADHD medication before we found Daytrana. It is the only medication that works for my child without severe side effects. My child can control the timing, still has an appetite and sleeps – things that were all impossible with other medications. The recall for difficulty removing the adhesive backing is ridiculous and has been harmful to my child.

  49. Andrea Reply

    Daytrana has been a miracle drug for my daughter. She has been on it for 14 years with no problems.

  50. cheryl Reply

    My 12 year old grandson has been on the Daytrana Patch since the middle of the second grade with no problems. I have him checked periodically, because of the mg that he wears. He went from the 15mg to the 30 mg and has done very well in school. Went from moving around the class room and excitability, and out burst of crying spells to assertitiveness, quiet, alertness, and complete concentration on his school work, that he’s been a a/b honor roll student since the 3rd gd, and he’s now in the 7th gd and doing well. Thankyou Daytrana for your medicational patch and the effectiveness it gives. His grandmother.

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