Singulair and fda

my grand child is almost 3 year old , he has been on singulair candy for almost 6 month , what we noticed is a noticeable change in his behavior in the form of nervousness , he turned cranky , recently his teacher reported that he is not him as before , his appetite in that good as before , he became nagging while he was a sweet child before singulair .

I am starting to think I would like to be a part of a class action law suit, my daughter had to switch schools because of her mood swings, and vague hallucinations. and vague paranoia. She once ran into a parking lot she was so afraid of needles! Took her to a psychiatrist, sensed she was quick to put her on mood stabilizers and left before the eval. Recently her ped refused to up her dose of singulair and told me about depression. I subsequently upped her flovent and took her off her singulair. I did this after I heard her teacher saqy she kept on leaving the classroom to go to the nurse, and was exhibiting defiant behavior. and saying she was depressed, hearing music that wasn't there, etc. Now that shye has been off of it a week, she is a different child, and hasn't argued with me once. Hasn't cried for 5 days. has not argued w2ith her brother either! I feel I have the child back from 5 years ago when she started taking it! unfrigging believable! I would love to sue, because these episodes have almost ruined my marriage, and caused me to miss many days of work, and feel guilty when I didn't Thank-God I just took her off of it on a whim!

I took my very happy, sweet, polite four-year-old son to the doctor yesterday because he was coughing horribly during the night. Great during the day, hacking at night. He was put on Singulair. I didn't think twice about it, since I am on it and have had no problems (although I take it sporadically since I tend to forget!). I picked him up from pre-school today and was told that he was a completely different child. Rude, put in time-out multiple times, refused to listen. This is behavior that he has never had at school, and the only difference is the Singulair. I will not be giving that to him again!

My son is 7 yrs old with allergies and asthma. The Dr. prescribed it and the same day I had talked with a lady which her friends son just committed suicide. They were contributing it to Singular. A quick look up on the internet and I was angry with the pediatrician that the side effect was never discussed with me! After a very reassured conversation I said I would start him with 1/2 dose. I noticed nightmares started right away and I stopped. Asthma got worse decided to star again 3 weeks ago. He started twitching his head, flipping his hair that isn't even long. He was also complaining of stomach aches and not wanting to go to school (very unusual)! He has been off for a week now and is hopefully will not ever have any long term effect! Please follow your instincts and I will let his doctor. know what the side effects were.

I recently stopped using singular as a medication. I experienced an extreme episode of depression. Has anyone else experienced this side effect and to what extreme?

I was put on Singulair two weeks ago and since then I have have experienced everything from hyperactivity and insomnia to flu symptoms and loose bowel movements. I contacted my doctor after 3 days because I was having tingling in my hands and feet, flu symptoms, cramping etc but no fever and otherwise fine...He said the benefits outway the side effects so take half. I continued to take half. The cramping reduced and so did the other physical type side effects, but I started feeling like Superwoman. Instead of sleep I sterilized my house, wrote emails, tended to laundry, etc...and then continued my normal day with a smile and pep that I would not expect. I really had no desire to eat. The thought just made me cringe. After two days of no sleep and hyperactive state I decided I am done. I stopped taking it...and I took my son, 6, off it as well. He had been taking it for 4 years and was presenting with signs of hyperactivity. It has been one week...he turned yellow, became more hyperactive, talked about how the man in his room is gone now. He had struggled with sleep since he started Singulair but there were no side effects at the time that listed bad dreams, hallucinations, hyperactivity etc...It has been one week and we watched our son turn yellow as he withdrew ...he could have been spider man break dancing on the ceiling for the first few days. His teachers and even the bus driver had sent home warnings about his behavior "can't sit still" ...the last 3 days of school he has been on "green" which means great behavior. I do not think anyone should give this drug to kids...and it should not be given in sample forms either to any doctor trusting patient...without a full discussion of these side effects. I feel like I just went thru hell and put my son thru hell.

Oh my! I've been having severe anxiety since i've started singulair. The anxiety leads to shortness of breath which is extremely scary r someone with my medical condition. I had to have valve replacement surgery 4 years ago so I am very sensitive to any abnormal feelings I have. I took claritin d or about 8 years and I wanted to get off this drug because of the pseudoephedrine. I am off this drug starting tomorrow and will take regular claritin without the pseudoephedrine. The anxiety I had was so great I might actually consider legal action.

I am 44 years old and have been taking singulair for about 4 years. 3 months ago I started experiencing crushing chest pain, tingling in my lower limbs, and felt very stressed out. I went to the ER last Thursday and was checked out for angina - the ER doctor told me I was suffering from chronic severe anxiety. I took Ativan for 4 days and felt better, but now the drigs are gone and I again having constant chest pain. In doing some research I found that anxiety can be caused by imbalance in adrenaline, and so started looking online to see if any of the allergy/asthma meds I am taking (adviar, singulair, allegra) can affect adrenaline. That';s when I found this website. Although i find the testimony compelling, I wish more folks would have poted about how their symptoms improved (or didn't) AFTER discontinuing singulair. Also I've noticed many of the stories are about children not adults; many people are taking more than one med for asthma, and most people's symptoms seem to come on right away whereas I have been taking sinulair for years and only recently have anxiety. I will stop singulair tonight and see what happens, but am wondering if anyone has come across further research that correlates singiulair with anxiety? My job life is really peaceful, I am otherwise happy, work can get hectic but that's true of any job, and I am out of ideas as to why suddenly at age 44, when I eat right and exercise - why get anxiety? Thanks for the posts, I'll try to remember to follow up after I am off Singulair for a few weeks.

My nine year old started taking this horrible drug less than a month ago. Since then, he has has horrible mood swings, screaming fits, told us he hates us, emotional breakdowns and even threatened to kill himself. He is a bright, intelligent, active and usually a normal nine year old. Over the past month he has been in a physical fight at school where he punched a kid for telling him he was annoying. He has also been in a ton of trouble at school which is not like him. I was so worried until today. My Mom recommended that I check the side effects of his asthma medication. I am astounded and angry at what I am reading. His doctor is supposed to have his best interest in mind and we trusted her. She was the attending physician at a hospital where we live. My nine year old was hospitalized with asthma. Although his asthma needs to be controlled, not at his emotional expense. There has to be a better way...

Please send your complaints to the FDA....

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049087.htm

I've noticed that my 13 year-old son have developed some repetitive rapid eye movements and a compulsive vocalization similar to a brief laugh since using Singular. Has any other reader experienced similar behavioral side effects in themselves or a child they are caring for while using this product?

I am 30 years old and have bad allergies. My doctor gave me a week worth of singulair as a sample. I took it last night. I woke up at 5 am thinking and worrying about the smallest things. I couldn't fall back to sleep. At the same time, my stomach is killing me... I feel like throwing up and have bad diarrhea... I will not take it anymore.

I took my daughter (14yrs old) off of Singulair 2 nights ago after being in the ER. She's been taking this drug for 3 years off and on. We were told she had asthma 3yrs ago and now yesterday after taking the Methacholine challenge test, she doesn't have asthma. Talk about being confused and angry. Over the last three years my daughter changed into a very anxious person, couldn't sleep at nights, very vivid dreams that made her surround herself with pillows thinking her dreams were real, sadness, chest pains, tingling in hands, arms & legs, knee pain (could be sport related?) and a very short fuse. I came across another website and then this one about the side effects of this drug and immediately took her off. She has slept better the last two nights but still has a little chest pain (indigestion), which I hope subsides soon. This has been a terrible stress for her and the whole family and I'm praying being off this drug will help my daughter restore her self confidence and happiness in her life.
A.

I went to my doctor last tues 'coz of shortness of breath. She found nothing & told me maybe i have anxiety. Told me to continue taking Singulair however since taking it last Saturday until now I still have the shortness of breath plus i couldn't sleep at night, i felt that I'm going to cry. After reading some of the experiences in this site I will stop using Singulair tonight & see what happens.

I am a 36 year old woman, and I have taken Singulair for the past 8 months. I got a lung infection over the winter, and the clinic I went to put me on the 10mg Singulair. It helped my lungs and got me over the worst of the infection, but I never anticipated the side-effects. For several months, I attributed what I was feeling to hormones (like severe PMS) and the stress in my life. I started to have thoughts of death, especially at night. I also began to have a hard time leaving my house. I would have panic attacks, worrying that the window was left open, the stove was left on, and god forbid there was a dark cloud in the sky (I became convinced that a terrible storm would come). Several times, I nearly got in a car accident racing to get home after work. Then, I started to obsess over getting sick. I was convinced that I would get some terrible disease and die soon. The fears and anxiety got worse and worse until one day (a rainy day), I quit my job of twelve years. It was a good job. I was happy with my work, and I made more than enough money. I ended up moving across the country back in with my estranged husband, because here I would not have to work. I could stay home all the time, away from germs and storms and anything else bad. That was three months ago. Still on the Singulair, I began to obsess over death. The panic attacks were so severe that they triggered asthma attacks, and not being able to breathe triggered more anxiety. I stopped sleeping at night. In three months, I've slept four nights. I began to have nightmares that made me wake up screaming and violently lashing out. I had to urinate 5 or 6 times every night. I developed severe stomach pain and nausea. And I had leg pain (actually, I hurt everywhere, severe pain). I had headaches, dizziness, and fatigue. Slowly, I began to realize that it might be the medicine. I started to research, and yesterday, I took my last pill. Since then, I have not had one panic attack. I have not had one asthma attack. I slept last night with no bad dreams. I know what's happened now, and I'm so sad that I lost so much of my life because of this drug. I really had a good life...friends, a home, a great job... Now, I'm very tired. My body is very weak and still hurting. I'm shaky. But I believe in time, those effects, too, will go away. I feel like my body has been through a war. I'm grateful that I didn't kill myself. There were a couple of really bad days when the urge to be violent towards myself was overwhelming. One day, I punched a fence, making my knuckles bleed. I think I could've killed myself, and I know it was Singulair. It's going to be better now. Just as a note: what helped me withdraw without any major worsening of asthma was Advair 250/50 twice a day.

My daughter who just turned 6 has been on Singulair for about 3 years now. Her behavior has not always been the best, but with her past medical history ( a preemie) and all the things we have gone through some times its just easier to give in than to fight over it!!! So last week she was suffering with her allergies and asthma and the doctor added a Claritin to be taken once daily. I didn't really think to much about it and thought well if it is going to help her the OKay. That was on Wednesday and by the week end she was literally coming "unglued". She was lying on the floor when she should have been in her seat at the dinner table. When she was in her seat she was doing "back bends" over the chair. We finally come to the conclusion that it had to be the Claritin, I looked up the active ingredient loratadine and knew I had to get her off it immediately. So now I started to investigate the Singulair as well, which I should have done long ago. Today will be the last day she takes Singulair as well. She has complained of her stomach hurting for a long time and I always blamed it on constipation, but it could be the Singulair. I can only pray that she will not have any lasting side affects.

i am 41 and i had been taking Singulair off and on for a few years. i had noticed that something was different about me but never related it to the medication. i always had a sinus infection every year, i stated having headaches and really depressed and didn't understand why. i stopped taking the medication and went and got me some Zyrtec and i have been doing just fine.

I am a woman in my early 40's. Started Singulair a couple of months ago.Bad idea. Prone to depression in the first place, I have had major anxiety attacks (thought i was having a heart attack) unstoppable crying, heart palpitations, nausea. I'm glad I found this sight--I thought there was something seriously wrong with me. It all makes sense now--it's been the Singulair. Can't believe I didn't put it together before.

Our 2 yr old son was prescribed Singulair for allergies by his ENT. He did great for a month. then started waking up more often at night, talking in his sleep. Never a fussy child unless he was sick- suddenly whining, protesting, acting out of character. Screaming when he didn't get his way. I threw away the pills the night he woke with a blood-curdling scream climbing the walls in his room- hallucinating that there were bugs crawling in his room. His pupils were dilated, heart was pounding and he was scared to death. A friend warned me early on, told me of her daughters behavior problems from the drug and told me of this website. She is doing great on Allegra. My son was to go off the Singulair in a couple weeks of our stopping the drug anyway, hoping he wont need any further treatment.

Our son, who is now 6 was prescribed Singulair at the age of 3 due to asthma/allergies. He was prescribed this by an ENT/Allergist. I thought our sons mood swings were due to the fact that we were expecting another child. He was always so happy/loving and playful. When the baby arrived 2 months later, his behavior worsened. Again, I put it on the new baby sister in the house. His moods/anger/outbursts increased. He hit, threw things etc. I told the doc about this and he said it was due to his enlarged tonsils, and they were then removed. Well needless to say, his behavior did not change because he was still on the Singulair. I mentioned the possible side effects to his pediatrician and she said it was a possibility, but to keep him on it because he needed it. Well, 3 years later, in March of this year I took him to an allergist that I had seen years ago. He immediately took him off the singulair (and all inhalers). His moods seemed to brighten a bit, but not they are worsening again. Is it possible for the Singulair to have long term damaging effects. I understand kids have tantrums, etc. Kids are kids, I get that. But he punches, kicks, screams, cries etc. My husband are at a loss. We don't know what to do. Oh, and he is now on Veramyst as needed (march-june, Aug-Oct.). Has anyone else experienced long term effects due to Singulair?

My son has been on singulair for 4 months now to control his asthma. It has done wonders in doing what it was intended to do, however, he's experiencing all of the side effects that the other parents are listing on this site. I threw his singulair in the trash a few nights ago after my son had a complete emotional melt down; which I could easily see he had absolutely no control over. I knew the drugs were changing his personality a bit, but I thought it was just the price we had to pay to keep him out of the hospital. My gut told me never to give him the meds because I had heard about the suicidal tendencies associated with the drug, I just knew I had to watch my son closely (plus he's only 3). I have 3 boys, and the one with asthma is my mild mannered, never gets in trouble, as close to perfect as a child can be. He's been saying "poop" and "pee" uncontrollably along with aggressive behavior toward his brothers and he would cry for no reason at all. His sleep patterns had changed as well, which I now know are due to nightmares - I even found him hiding under his bed a couple of times. I do not know why this drug is approved for children, but after reading the other stories I realize this seems to be the standard instead of the exception. I hope they pull this drug off the market before any more kids get hurt. I feel like I have poisoned my child - I will definitely be spreading the word on this. Anxiously awaiting for this medicine to leave my sons body so I can have my sweet little boy back.

Hi, my name is M. I just got up with my son Jo Jo as usual about 2:00 pm. Nightmares--severe. Leg and foot pain. In fact I thought he was having restless leg syndrome and the doctors had him tested for seizures. His moods are horrible. Tantrums have been out of this world. After two years of sleep deprivation for both of us, something said look at side effects of Singulair. Actually, I believe that something was God because as I massaged my son's legs I prayed. I came to the computer, found his website and saw my son's symptoms written out clear as day. We are done with Singulair. Forever. I just walked back to the room and apologized to my sleeping son. I can not tell how horrible I feel as a parent for my child to have suffered so. I also can not begin to describe the relief I feel right now. My son has enough problems without medication causing him to suffer. I have suffered as well. As a single parent I have to work but I am often sleepwalking through my days. Thank God for all of you who posted. You have saved my son's health and quality of life. And mine. Thank God!

How Many parents would be willing to go to the FDA headquarters and picket to get this drug relabeled?The official location is in Maryland.Contact me on this site via-private Email.K. M.

My son was on singulair for most of his infancy (11 mos- 22 mos old) we took him off of it when I started staying home with him. He was in daycare and was having breathing issues. We would give him the singulair and Zyrtec every morning. He became a very despondent baby. He would spend the ENTIRE day in the rocking chair at the daycare. After months and months of the teachers telling me this we decided it was best I stay home with him. He came off of the singulair and things got so much better for a while, he began to interact with us and others, not fearful anymore, and slept through the night. However other things have grown to be worse, as he has been developing...every day he seems more difficult to deal with. Now, 5, he is angry, fits of tantrums and rage, can't cope with his emotions, he actually kicked me today during one of these fits. He has been peeing in his room when he is sent there because he has been punished for one of these outbursts. What are the long term after effects of Singlair? Has anyone had this experience? Could the singulair have been given to him too early and now caused some sort of permanent nero or psychiatric condition? PLEASE ADVISE!!!! This Mom is really frightened.

i have been suffering from nightmares, irritability, moodiness, anger, hopelessness, agitation, hallucinations, fatigue, behavioral problems, withdrawal from my spouse, loss of interest in my everyday life.
i never put anything together about the weight gain until i read some of the responses on the web. I attributed to being 40 , loss of activity etc.

Hi, I was on Singulair for two years and I had one additional side effect that I've not seen anyone else mention: allergy-like reactions to antibiotics. Prior to taking Singulair I had a bad reaction to only one antibiotic, doxycycline. I had elevated heart rate and blood pressure and ended up with what I was told is called intracranial hypertension or high blood pressure in the head which is the worst and most severe headache I've ever experienced.

While I was on Singulair I had the same reaction to every antibiotic that I was prescribed and they were all antibiotics that I had taken in the past without any problem. I stopped taking Singulair about a month ago and was able to take an antibiotic again without any problem. Every medical professional I've talked with about it said it was news to them and they've never heard of such a side effect.

This was, of course, in addition to many of the other mental and emotional side effects that other people have posted about: severe anxiety, suicidal thoughts, depression, inability to think coherently. The worst was just before periods. I figured it was wacky hormones after having my son but my periods since stopping stopping Singlulair have been WORLDS different. The first was within a few days of stopping and I had really heavy flow with lots of clots. (I know, TMI... sorry!) The most recent period came with mild PMS instead of the mental near-incapacitation accompanied by paralyzing anxiety and depression that I had been experiencing the past two years and the period has been relatively mild and manageable.

One more side effect I want to mention is intestinal cramping. I have been having increasingly frequent intestinal cramping and pain over the past year and had no idea what was causing it. I missed work and spent long periods of time in the bathroom expecting diarrhea that rarely came. Since stopping Singulair that has stopped as well.

All I can say is that Singulair was clearly not the drug for me. My entire life has been improved in just 3 - 4 weeks since I stopped taking Singulair. That's good considering my entire life was turned upside down over two years of taking it... at least the improvement has been faster than the degradation. Now if I can just get my asthma under control again (no, Singulair did not manage the asthma well to top it all off) I'll be doing beautifully!

It is a disgrace that the FDA announced pending labeling changes for Singulair on June 12, 2009 and almost 2 MONTHS later, it does not appear the changes have been made.

I was prescribed Singulair on a Tuesday & started taking it that evening & that night I began to have horrific dreams. My dreams are usually very vivid & crazy but once I started taking the Singulair they turned really dark & scary. I would wake up freaked out & didn't want to go back to bed. My day time events would roll into my dreams & become so warped and I would wake up confused if what I dream was real or not.

By the Friday after I started taking Singulair I was experiencing anxiety. I felt like I had been drinking coffee all day (I don't usually drink coffee so when I do I get very anxious). By Saturday I was depressed. I didn't want to go out & socialize & I didn't want to be around my husband. I just sat on the couch with my mind spinning out of control with sad thoughts - for example - wondering why husband loved me, whether my parents were healthy & imagining what I would do if they died.

On that Sunday night I was laying down trying to go to bed & my right side was tingling. Since it wasn't the left side I didn't think much of it & tired to ignore it. It took me a long while to fall asleep that night because of worrying about the tingling sensation as well dreading what I was going to dream of. Well, I had the most messed up dream that night that I can't even talk about it without crying. I woke up at 3am & finally came to the realization that it could be the Singulair causing all these problems. I got on my computer & found this website.

Needless to say I stopped using Singulair immediately after reading these testimonials. I met with my doctor that next Tuesday & told her what happened & what I had read. She told me how she had just read the FDA report about 2 weeks before I saw her but didn't think too much of it because she prescribes Singulair about once or twice a week & has never has a patient complain about a mental side effect. I told her to be careful b/c these people may not know what is going on with them & may not be able to put 2 & 2 together b/c who would think an asthma & allergy medication would mess with their mind.

My doctor then prescribed me the Symbicort inhaler and I haven't used my albuterol inhaler once since I started using Symbicort. Mind you I have very mild asthma symptoms.

My son was put onto 4mg Singulair when he was three years old. He is now six years old. For the past three years he has been a very quiet child, to the point that people commented on how shy and withdrawn he was. He never wanted to go anywhere or do anything. His favorite activity was lying on the couch watching tv. He was always thirsty, frequently went to the toilet,often complained of a sore stomach & had several bowel movements every day, did not sleep well at night, was often grumpy, could not concentrate for very long, was frequently ill with cold-like symptoms and did not really like you to touch/hug him. At the beginning of the year he was diagnosed by an occupational therapist as having low muscle tone. In March of this year, his pediatrician increased his singulair to 5mg. He began having terrible pains in his legs, to the point that he would cry and be unable to walk to the toilet at night. I took him to my GP who did every blood test under the sun and x rays of his pelvis and legs. He could find nothing wrong. The only thing that had changed was the increase in Singulair. I had a look on the internet and found this website. I immediately decreased his dose to 1/2 a tablet for a week and then 1/4 tablet for a week before taking him completely off it. Within a few days our whole family and his teacher and therapist noticed a huge change in his personality! He talks all the time now, he laughs a lot, he loves playing outside and has lots of energy. He teacher says he is much more receptive at school. His occupational therapist says his muscle tone has improved. He has not had one single leg pain since coming off the medication. He is sleeping well at night, his stomach is never sore and he has not been sick at all. Not even one little sniffle!! Best of all he is a normal, affectionate little boy. I feel very angry with the manufacturers of Singulair and with his pediatrician, it feels as though my son has lost three years of being a child. He felt terrible all the time and I had no idea! I have told everyone I know who has a child on singulair to look at the side effects.

Just finished reading the posts and I feel like it was written about my 8 year old. I never connected the two issues of anxiety, frustration doing schoolwork, quick to tears and leg pains. I kept telling them they were growing pains. Last night he called me from his father's and said he has suicidal thoughts... not that he wanted to kill himself, just couldn't stop thinking about it... good lord. After months of dealing with him not wanting to go to bed and not feeling safe we have an answer. I told my ex husband to stop the medication today, I will post back after a few weeks to update the progress. I usually never post randomly on the internet, but this site might have just saved my son from emotional turmoil!

I started singulair a week ago in order to treat my allergies and mild asma. At first, I did not realize that I had headaches and head pressure due to its adverse reactions. On Friday night after my dinner I got very bad vertigo, and I did not take singulair for a day. Believe it or not my vertigo and headache went away. Tonight, I tried it again, and my ear and head pain came back.
I am calling my doctor tomorrow and stopping it right away.
Thank you all sharing your experiences.
V.

Our 19 month old son was diagnosed with RAD (reactive airway disease) and our pediatrician is very hesitant to call what he has "asthma". His two bouts of wheezing were both associated with viral respiratory infections. However, after this infection and the seasonal allergies he seems to have, the dr. prescribed Singulair (4mg granules) to us to help control our son's wheezing and coughing. After being on it three days, he's not the normal laid bad but energetic boy that we know is ours. He's mean...he's aggressive...and he's biting so much at daycare that they have assigned one person to shadow him all day long. We took him off of it yesterday, so we're now 24 hours singulair free. I'll post any differences we see in a few days, but for now it's our firm belief that Singulair is what is making the difference.

My 11 year old son started singular in March of 2009 for exercise induced asthma. Within weeks he started having symptoms of heartburn - which he had never had before. I brought him back into the dr. mid June- they said wasn't related to singulair and actually increased his does from 5 mg to 10 mg. Since increasing his does, he started experiencing, daily headaches, stomach pain, leg cramps, night sweats w/ shaking & overall FEAR. Last night he was in tears - he kept saying there is something seriously wrong with me - I can't stand feeling this way he was afraid he was going to die and didn't want to go to sleep.

Last night I did my own research and found this board. THANK GOD!
He didn't take his singulair last night & he never will again.

I called his dr. this morning to tell them I think he is having negative side effects from singulair. They actually told he it was "HIGHLY UNLIKELY" his symptoms were related to singulair and NOT TO STOP USING IT. They instead said I should start giving him pepcid. I told them he had stopped it - for good and that we need a plan B for is exercise induced asthma. Looks like my plan B is finding a new Dr. that isn't in bed with Merck.

Has anyone had any experience with a NATURAL approch to controlling exercise induced asthma?

Our 11 yr. old daughter was prescribed with Singulair. She started taking it today with much hesitation from her parents. She was on this medication years ago for her mild asthma, but her mood swings/depression were terrible. We have a new ENT now and he promises that the mood swings/depressions are NONSENSE and that these rumors were put to rest years ago. We will be watching her side effects closely, but my question is if Singulair helps so much, what other medication can someone take that does not have these side effects? What is the alternative? She is also going to see a pediatric pulmonologist in August.

We put our 3 year old son on Singulair 2 weeks ago for allergies. It seemed to be helping him. He is a very mild mannered kid that has never been an aggressive child and never bites or hits. In the last 4 days his mood has changed, and he has bitten 2 kids at school, hit one kid, bit and hit his grandpa, has been waking up with nightmares and has been very clingy to me (his mom). After reading the side effects of Singulair last night we contacted the pharmacist and told him what has happened and he told us to take him off the Singulair immediately and contact our Pediatrician. I am waiting for a phone call back now. I am saddened that a medication for Allergies can cause such a personality change.

My eight year old son was diagnosed with mild asthma by our GP and was taking Ventolin for a persistent cough. When this didn't relieve the cough the doctor prescribed Singulair. He started the Singulair in March 2009 and within 2 months we realized that his personality had dramatically changed. It has taken us a while to figure out what was going on because eight year old boys are starting to assert themselves more and I think the side effects have been escalating over the last month. He was angry most of the time, very hateful towards his siblings, saying very dark, nasty, hurtful things. He argued every time we asked him to do something and would snap into a screaming inconsolable emotional wreck at the drop of a hat many times a day over trivial or imagined problems. He was having nightmares and bursts of hyperactivity that were overwhelming. He told us he felt frustrated all the time and hated everything. When we tried to calm him he was unreachable. Just yesterday he had his fist clenched and pulled back ready to punch me when I was trying to help him with a computer problem. He was shaking and his face was contorted with rage and he just wasn't my little boy anymore.
It has been devastating for our family and we were ready to take him to a psychologist. He is normally an incredibly considerate, perceptive, loving child, highly intelligent, helpful and fun loving with a great sense of humor.
He has also complained of leg pains and has been wetting the bed again. It was only yesterday that I began reading about other people's side effects and have taken him off Singulair as of last night. Whilst he has still been argumentative today already the aggressive intensity seems to be easing.
I am absolutely mortified that I allowed this to happen to my son and my family and I am so grateful to others for sharing their experiences.
We still need to address his asthma and will make an appointment with a specialist next week, but given his asthma is so mild he should not have ever had to suffer these side effects.
I only hope now that he has not sustained any long term effects and that his younger brother has not been scarred by the truly horrible things that my son has said to him.

Worst night of my life--woke up feeling filled with anxiety, insomnia, had to get up repeatedly to urinate, felt very agitated, though I felt very peaceful & relaxed at bedtime, feet were swollen so badly I couldn't put on my shoes. I took 10 mg of Benadryl, which did not change how I felt. My internist took me off the Singulair immediately, when I contacted him the next morning.

Despite being on an antidepressant which was recently increased, very recently I felt sad, anxious, and was crying all the time, felt irritable, and was chronically tired. I took 400mg of gabapentin (Neurontin), prescribed for nerve pain, numbness, tingling in both hands & feet at 9 p.m. Just before bedtime at 10:00 I'd take 10 mg Singulair. 1-2 hours later I was wide awake, sometimes not sleeping for hours or at all, even after taking 1-2 Benadryl, without the dyes.

Over the past two years I've had eczema, for which I saw 2 different dermatologists and an infectious disease specialist. Eczema was so bad, I couldn't sleep at night. I consulted with every imaginable doctor, including the allergist who prescribed Singulair & was told it couldn't be the Singulair because Singluair was FOR ALLERGIES. Was diagnosed with fibromyalgia by a neurologist, recently had a repeat of an MRI because I couldn't walk the pain was so bad. My neurologist was unable to find any reason I had pain & difficulty walking, after reviewing the results of the MRI.

I've seen my internist for heart palpitations. When I reported urinary frequency, he had me get a cystocopy (negative) because I had hematuria, blood in my urine, and I had weight loss.

I still have many of the side effects, like the numbness & tingling in my feet and hands, however, I am able to sleep through the night and did so immediately after going off the Singulair. A lot of the fibromyalgia pain I was having has subsided, depression, anxiety has subsided as well.

My daughter is a 4 year old child started on Singulair after she was unable to tolerate Zyrtec. For the first few days her allergies seemed better and we were encouraged by her improved allergy symptoms (allergies to poplar trees, grass, and lambs weed manifest as headaches, itching (usually of the extremities), and stomach aches). However, after 2 days her behavior became increasingly erratic. She was emotional, tantrum prone, irritable, anxious, and had difficulty sleeping although she appeared and said she was exhausted/tired. After several weeks on Singulair, we stopped the medication to determine if it was causing the behavioral and sleep problems. The symptoms stopped after discontinuing Singulair and she went back to her usual happy, well behaved self. After being off of it for several weeks we decided to try it again due to her allergies flaring up and wanting to be sure it was the Singulair causing the behavioral problems (because for all of its negatives, the greatest positive about Singulair is that it definitely helps her allergy symptoms). Unfortunately, the irritability, anxiousness, tiredness, tantrums and insomnia returned. We tried giving it to her at different times during the day but the symptoms were still present (although she slept a little better when we gave it to her in the morning). We also tried cutting the dose in half and giving it to her around noon. Decreasing the dose did help with the symptoms to some degree, but they were still bad enough to outweigh the benefits of taking the drug. As a nurse, I love Singulair for the relief it provides allergy sufferers...unfortunately for my daughter, the side effects outweigh the benefits. Given the rates of ADD, ADHD, and other behavioral problems diagnosed in children nowadays, I thought it pertinent to report these symptoms present in my daughter that are solely caused taking this medication.

I am 31 years of age an suffer with severe allergies, I was put on Singular about a month ago but didn’t start getting symptoms until 2 weeks ago I thought it was me but I soon realize it was not , I have severe stomach pains I like to describe as muscle spasms’ very painful, I had swollen eyes always puffy and sore throat. I realized that I didn’t start to have all these issues until I started the singular so I stopped 3 days ago and the spasms have since stopped the sore throat is getting better and the puffy eyes getting much better.. My father in-law told me to look up this site and I am so glad to see that I was not the only one and I wasn’t going crazy thanks everyone for sharing your stories
S.

My 4 yr old son was recently put on singulair for his asthma.
He went from being a little boy who settled straight down to sleep at night to a boy who was running around his bedroom very hyper and not being able to sleep at night. After a week of this we started to give him the singulair tablet in the morning and this resulted in him getting in to trouble at school and becoming very aggressive. After 2 weeks he is now completely off singulair and I have my happy little boy back!

I am so glad to have found this site. We are taking my 2 1/2 year old son off Singulair immediately. He has been experiencing a rash on and around his ears, around his hairline, back of his neck and shoulders, down his arms to his wrists and on his face and below his chin - almost everywhere above the neckline. At first we thought it was a reaction Singulair and took him off the medication. When it didn't subside, we took him to his pediatrician's and they told us it was a heat rash due to a reaction to sunscreen and sweat. Since I have had that reaction myself, we agreed with the doctor's diagnosis. We restarted him on Singulair and the rash only got worse. We've taken him off the Singulair and will be contacting his allergy/asthma doctor immediately about this reaction. We are not sure if he has experienced other side effects - we have seen an increase in him crying when he goes down for bed and wanting to snuggle, as well as not wanting to be touched on the legs (not sure if that's due to his scraped knees or not). Unfortunately, it's difficult to get a 2 1/2 year old to tell you exactly where it hurts.
Thanks for the information - we now know that we were correct in the beginning and that our son does not have to go through this any longer and can enjoy his summer.

My husband has been on Singulair for ten years now. It was a miracle drug for us as his asthma and allergies were ruining his quality of life. Little did I know that the Singulair would have such drastic effects as well. He is a police officer who has been through some traumatic events in his career. I attributed his irritability, depression, anger, severe nightmares, heartburn, weight gain, and puffy swollen eyes to post traumatic stress disorder. He stopped taking the medication about two weeks ago after his prescription ran out and he saw the FDA report. He is once again the man I fell in love with. Now I know what has been causing all of the changes in him, and we have decided he will never take Singulair again.

Extreme aggression and anger in my 2 year old. He has been on singulair for six months now and has been kicked out of two schools for biting and hitting for no reason(sometimes when the victim was asleep). Our allergist told us to take him off the drug three days ago and we can already see much improvement.

My 13 year old daughter has been taking singulair for 8 months, and started suffering from severe depression 6 months ago. We intervened and prevented her from committing suicide, but barely. We never correlated it with the Singulair until a visit with her pediatrician today. I am so sad I want to cry. I am the one that suggested to her asthma specialist that she be put on Singulair. I am so fortunate her pediatrician caught this. We couldn't figure out why her personality suddenly changed.

My 11 year old step-daughter has been on Singulair for 3 years and has had trouble sleeping - waking up 8-10 times nightly, sometimes with terrible nightmares as listed on some of the other posts. Thank you so much for sharing this info. We took her to an ENT today and the only thing they offered was to take out her tonsils and adnoids but the were basically normal - all they wanted was money the way I see it. We are taking her off all her meds tonight; she also takes Asmanex, Nasonex and Allegra.

I am so thankful that our MANY voices are finally being heard I am grateful that the FDA is finally forcing MERCK to add a warning to its label, but we must still keep fighting until there is a blackbox warning on this medication. My daughter committed suicide after three years of hell on this medication. The world has lost a beautiful, fun, and highly intelligent young woman because MERCK is so concerned about its billions of dollars in sales from Singulair.

If you have had any side effects PLEASE REPORT TO THE FDA! It is up to us to make them aware of how devastating this medication can be.

As i read some of the news reports on the new FDA comments,i see we are referred to as a handful of reports,the very words handful conjure up a picture of 10 not the thousands that there actually are.Also i noted missing from the news reports was ,that this drug is largely given to children,as young as 6 months,not for 10 days or 2 weeks but everyday,for as long as they need it.i know myself trying to convince my doctor,that my sons depression,insomnia and anxiety,came from this drug was impossible,so i fired him.I am wishing the best to everyone that has suffered,and ask all to please report your adverse effects to the FDA

PLEASE REPORT SIDE EFFECTS OF SINGULAIR TO THE FDA: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

The FDA is continuing to monitor ongoing reports of suicide and other psychiatric problems.

From the FDA's "Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)"

6/12/2009

Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling).

Montelukast is used to treat asthma, and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose), and to prevent exercise-induced asthma. Zafirlukast and zileuton are used to treat asthma.

The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

This information reflects FDA’s current analysis of available data concerning this drug.

Advice to patients and healthcare professionals:

Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.

Patients should talk with their healthcare providers if these events occur.

Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Background

In April 2009, FDA completed its review of neuropsychiatric events, (mood and behavioral changes) possibly related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As part of its review, FDA reviewed post-marketing reports and also requested that manufacturers submit all available clinical trial data for these products.

The post-market reports of patients on these medications included cases of neuropsychiatric events. Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo.

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I am 40 years old and recently went to my medical facility as I have had a "viral" ear infection for almost a year now, and it is concerning me. I do not take medication typically. My new primary care provider recommended I try Singulair. So far I have taken three doses over three nights. The first night was horrifying, the dreams I had were so scary, and they were tied into reality which was even stranger as the drug also makes you wake up often, then when you fall back asleep your awake time ties into your dreams. I woke up in a numb state. Since then, I also have been extremely agitated, dizzy, mouth sores, acne, fuzzy thinking, light headed and severe fatigue and body aches. Thank goodness I checked out this webpage, as I too will stop taking this drug. I find it very disappointing, how are we suppose to be able to trust our medical professionals to help us with one of our most prized possessions, our bodies, when we are given something to clear up an ear infection only to have it affect numerous other aspects of our lives to such a serious degree with no mention from our medical professionals. This is ridiculous. I guess I'll live with the viral ear infection.......