Singulair and singulair

It has been interesting for me to read this posts. I have been wondering about the long term side affects to singulair- mostly because my 11 year old has been on Singulair for several years now. We spent many of nights in the ER for asthma when he was little and no Dr. did testing. When he was 5 his pediatrician tested him for allergies and put him on Singulair. We have had a great experience with it. I find it interesting that many of the health issues on here- joint pains, bouts of depression, weight gain...I personally experience all of them and i am not on any medication. My 11 year old does not experience any of the mentioned side affects. I wanted to find out long term side affects for my own personal knowledge. Prior to Singulair, he was on Zyrtec which was not a good fit.

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!

I am looking for any information anyone has about the possibility that Singulair causes colitis or that it can lead to inflamed colon and bleeding colon. My daughter is 4 years old and has never been a sick child. In September, she started bleeding from her colon, and a month later, she was finally diagnosed with colitis after having a colonoscopy. The doctor prescribed Prednisone (steriod) and Phlagyll (antibiotic) (spelling?). I decided to stop giving her the Singulair that she had previously been taking because I didn;t want her to have so many drugs in her system as one time. After a few days of the steriods and antibiotics, she was well, with no signs of problems. Everything was going great for a few weeks, but last week I started giving her the Singulair again, and her colits symptoms have come back. Has anyone else experienced this in relation to Singulair?

I have been taking singulair for about a year and a half. Honestly I have had no side effects. It works great for me. I have tried to just take my zyrtec for my allergies without the singulair. I notice that if I don't take the singulair I feel shortness of breath and have to use my inhaler. When I combine singulair with my zyrtec I don't even need my inhaler at all. I was reading some of the experiences from other people, I think maybe children shouldn't take singulair at all.

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.

Regardless of whether singular has weight gain listed as an "official" side effect, singular is: Montelukast Sodium (generic name), meaning, sodium is sodium, is Na+! Edema & weight gain WILL occur is individuals sensitive to sodium's effects.

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.

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?

can someone please tell me how long it took for their child's thought to return to normal? My son has stopped singulair four days ago after reading this website. I had ruled out everything but could not find out what was wrong. After putting in his symptoms and that he took singulair i couldn't believe that I found it matched. He had stopped taking it for a month and had started back up on it. Please respond to a nervous mother of an eight year old who was a happy child who now had thoughts of knifes and scary thoughts

I was on Singulair while pregnant because my asthma got worse while pregnant. Postpartum I noticed my 2 month old breastfed baby was still sleeping way too much and very colicky. I tried cutting out dairy and other allergens but nothing made a difference. When I forgot to take my Singulair a couple days in a row, I noticed my mood was much improved and the anger/irritability went away. Finally, after noticing I was having vivid, bad dreams, I began to realize it might be all from the Singulair. I also had developed a stiff, tight neck and vision loss, which I now realize was also from being on Singulair.
I went off of it and must say, that was the worst week of my life. I never felt so horrible or out of control. Although I noticed the first few days, I was happy and feeling again (it made me emotionally numb) by the fourth day, I began having heart palpitations and bad headaches. I quickly got my thyroid levels checked and those were fine. Then I suddenly had severe panic attacks! I thought I was going crazy! This was mistakenly misdiagnosed as PPD, although I was never even depressed. I was given a script for Zoloft and took Ativan but that didn't take away the panic and the Zoloft seemed to make the panic worse!
I began researching and realized all of my symptoms were from Singulair withdrawals! Even my family noticed I became a mean and hateful person with this last pregnancy. This drug is an awful poison! I am slowly recovering and feeling better everyday. I'm using my fast acting inhaler for the time being. Instead of the therapy I thought I needed for PPD (mis dx'd obviously) I'm also using herbs to treat this homeopathically with a natural doctor since conventional ones still want to pass it off as something it is not due to ignorance that an asthma medicine can wreck this kind of havoc on a person! They just want to use more drugs to treat the side effects of another drug!
I am so angry I took this while pregnant and breastfeeding being told it was okay. It was not okay and I hope and pray there are no long term side effects to my child from this drug!

SINGULAIR'S LABEL HAS BEEN UPDATED:

The following has been added to the "Precautions" section of Singulair's label:

"Neuropsychiatric Events
Neuropsychiatric events have been reported in adult, adolescent, and pediatric patients taking SINGULAIR. Post-marketing reports with SINGULAIR use include agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some post-marketing reports involving SINGULAIR appear consistent with a drug-induced effect.

Patients and prescribes should be alert for neuropsychiatric events. Patients should be instructed to notify their prescribe if these changes occur. Prescribes should carefully evaluate the risks and benefits of continuing treatment with SINGULAIR if such events occur (see ADVERSE REACTIONS, Post- Marketing Experience)."

I have an 8 yr old son that has allergies and asthma. The allergist recently prescribed Singulair which my son had taken when he was 5. We took him off of it back then due to anger outbursts. By the way, the Dr. said that was not a side effect, but nonetheless the issues subsided. When it was recently added back to his medication list, within 3 days he had anaphylactic type episodes 2 days in a row. The attack started with stomach pains, chest pains and then he couldn't breath AT ALL and turned blue! There was no time to call 911 so I gave him an Epi Pen. The attacks are still occurring yet milder and all his Dr.'s swear by Singulair and think I am crazy. I took him off Singulair immediately and we are still waiting for it to leave his system. I think that is why the recent episodes have been milder. He has been tested for all sorts of allergens which he did not come in to contact with prior to the anaphylactic events. We still have no answers and if I hear one more Dr. talk about how great Singulair is, I am going to freak out!! To heck with these drug companies and doctor's who get perks for prescribing medications without informing us of side effects.

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!

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.

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!

My name is Katie, I am 31 years old. I have been suffering with what doctors call Chronic Idiopathic urticaria for 16 years now. I was prescribed Zyrtec 14 years ago and remained hive free until I had my first son. After a complicated pregnancy and emergency delivery the hives returned full force. The doctor prescribed Singulair in addition to the Zyrtec.

The hives went away; however, I have so many other problems now. I have been seeing a specialist thinking I have lupus or some other disorder, but all my tests are normal. It wasn't until I had my singulair refilled yesterday that I realized instead of symptoms, what I am experiencing may be side effects.

-- I have gained 60 lbs.
-- I have horrible headaches almost daily
-- I am so tired that when I am not working it is impossible to even make myself leave the house
-- I have taken myself to the hospital 3 times thinking I was having a heart attack and told I suffer from acid reflux
-- I have so much pain in my legs/feet/back that I can hardly walk
-- My hands and feet like to go numb for no apparent reason
-- I am always anxious & moody.
-- Can't sleep
-- Clearly I am not myself. Lately, I have felt the quality of life I am leading is horrible.

Wouldn't it be something that I have spent all this time & money trying to figure out what else is wrong with me when it is the medicine I thought was keeping me well really making me sick. Why do the finest doctors not realize when your symptoms are actually side effects?

I am pretty out raged at this point. I would take myself off this medication today if only I knew how to control the edema.

I have been taking Singulair for 10+ years. My asthma is controlled. Up until this drug assisted with Pulmicort my asthma was very difficult to control. I am 53 and healthy otherwise.

I have experienced problems with my knees in recent years as arthritic pain and tearing a meniscus. However, this joint pain continues. Similar problems anyone?

In a study, Sudafed 24 Hour and Singulair proved equally effective for treating the most common hay fever symptoms, such as sneezing, nasal congestion, runny nose, and nose and throat itchiness.

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.

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.

I have no idea what most of you are saying. My son has cronic severe asthma and there have been times where he has been close to dying. He is 8 yrs old and been through a lot more than most people have been their entire lives. He has been on singulair for about 6 or 7 yrs now and he hasn't any problems with side effects that any of you are talking about. Before he was put on singulair controlling his asthma was almost impossible. For the parents who have not given ao have just stop giving their children their medication just like that. You should talk to you doctors because I know first hand how dangerous asthma can be. If any parent has ever had to rush their child to the ER and then you child was put into the icu for weeks at a time. You will think you lucky stars there is a medicine like singulair out there. Thank You for letting me share my story.

My 4y/o son has asthma that was not well under control, so the doctor put him on Singulair and Flovent about 2 months ago. In the first few weeks, he started having severe leg pain. He would be up at night crying. I would massage his legs till he went to sleep. He also started soiling his underwear with small thick amounts of stool multiple times a day; despite the fact that he has large soft bowel movements at least twice a day. His asthma has been well controlled since the start of the medicine. We stopped the Flovent 1month ago to see if the Singulair would continue to control his asthma, which it has. We adjusted his diet, since the doctor attributes his stooling to constipation, which has not helped. He is now frequently peeing his pants and frequently complains of arm and leg pain which comes on suddenly and seems to last for 5 to 15 minutes. I am going to take him back to the doctor for a full check up to rule out anything more serious, such as a spinal tumor, but till then I am going to stop the Singulair and see how things go. I wanted to stop it as soon as the incontinence started, but was afraid of his asthma flaring back up. Is flovent causing anyone's kids any issues. My son also seems to be having trouble getting his words out.

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.

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.

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.

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

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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My 4 year old daughter was taking Singulair before bedtime (for asthma) and developed vicious bad dreams. I took her off the Singulair and the bad dreams disappeared. Through web forums I learned that this side effect has occurred in many children. For the past 2 months her asthma has been completely controlled through the use of a nebulizer and inhaler. I found out the Pediatricians and Nurses and our care facility were not even aware of this side effect. Why is such a mind-altering drug being prescribed to children? And why does a medicine that produces bad dreams require it to be taken before bedtime? She was also taking Zyrtec to control allergies. Her doctor mentioned that it could be taken any time of day, so we gave her the Zyrtec in the am and the Singulair in the pm. One morning during allergy season we forgot to give her the Zyrtec in the morning, so we gave it to her at night. Five hours later she was crying hysterically! It took hours to get her to calm down, and this girl is a very happy, social, well-behaved and well-adjusted child. I stopped both medicines the next day and within one week the bad dreams disappeared. So I would also cautious parents about Zyrtec as well.

Took it for a week. During the time I developed a sinus headache that would not go away. Sinus pressure, pain, congestion. Today had rapid heart palpitations and anxiety. I called my doctor and he said to stop taking it. I haven't felt like this since before I started taking Wellbutrin. I wonder if it interferes with it. I've read others who take Wellbutrin and after taking Singulair started having depression and anxiety. My boyfriend told me to stop taking it. I'm glad he did! He said when he took it, all his friends noticed major personality changes. It took it 2x/day for 3 months!

Doctors can be quacks and will throw any script your way. Be conscious of whats being given to you and if your Doctor really listened to your symptoms.

My 4 year old Son has had diarrhea from about the last 4 weeks... we have started some tests for Celiac disease but today it only occurred to me today that he has been on Singulair for about that time frame... after all the worry and reading these other storied Im even more convinced that it maybe the Singulair..
Im just hoping that someone might read this sometime today or the next couple of days to tell me if when they come off the singulair how long did it take for the diarrhea to pass. My son had is last tablet 2 nights ago ( so he has only been off it so far for one night. But he still has the diarrhea.. should it have started to come out of his system already.

I am 39 years old and very active. I have been on Singulair for about 2 years now. I did not think I had any problems while on the medication because it did help my breathing. I am now on an antidepressant (Lexapro)which I began about a year after I began the singulair. My depression however started almost a year before I actually got on the Lexapro. I had alot going on in my life so I just equated my depression to that. However I am realizing now that maybe the singulair triggered my depression. I ran out of singulair two days ago and am experiencing withdrawal symptoms, extreme tiredness, stuffy head, and I had heart palpitations last night, which I have never had. The withdrawal symptoms are why I began researching the medication because I couldn't understand how being off of it for such a short time could cause such an effect. I was on Singulair once before about 6 years ago before I retired from the military while I was at Ft Hood before I deployed to Iraq. By the time I left Iraq I was on multiple medications, Singulair, Claritin, Advair, Emergency Inhaler, When I arrived in Iraq I became ill and listed my medications. They were in shock and took me off everything except Claritin and I was fine. It wasn't until I returned home I began the Singulair again. (Why? I guess I never equated it to causing my other issues until now), I am also taking Zyzal and Lexapro. I see now that every time I take the Singulair it leads to additional medications to other things. I am going to stay off of it and hopefully be able to wean myself off of the Lexapro as a result. Unfortunately I probably will still need to take an allergy medicine. Thanks everyone for posting this useful information. I have two kids 6yrs and 12yrs and I know now that they will never take this medication. They have allergies like me so it is very probable that eventually it would have been mentioned. The allergist/asthma doctor is adamant the 12 year old has asthma but I never gave him the advair that he wanted him to take because I did have side effects from that medication that I did recognize myself and my son is the fastest runner on his select soccer team and extremely athletic without it, no emergency inhaler needed or anything.

May 25th, 2009
11:20 A.M.

Started Singulair 5/14/09. Within last week or so started having extreme pain in shoulders, hands (especially thumbs), wrists and hips. Put ti down to arthritis. Pain has been getting worse every day. Thought it was a food allergy so stopped eating fruit and have cut out all sugar. Yesterday realized that pain has increased so it wasn't the food. It suddenly dawned on me that it could be the Singulair. Stopped taking it last night and am already much better. Still some pain but not so excruciating.

About a month before my Dr. gave me Advair. After a few days on it, I went to bed and thought I was having a heart attack. Pain across my back and down my arms, up my neck and across my chest. This happened 2 nights in a row and decided to stop taking it. Called my MD and he said to stop it immediately. However, he thought it really might be my heart so I had an echo cardiogram and stress test. They said my heart was perfect. After 2 days off the med had no more trouble..

My take is that these "air" drugs are not for me. My MD is on vacation and won't be back until Wed. I will speak with him then. Hopefully by then all paij will be gone. Will post again to report results of stopping Singulair. Reading all these posts also made me realize my depression, irritability and crying has probably been a result of this drug.

By: Fed Up

im having cough and then wheezing for a couple of minutes. My doctor thinks its common allergies, but I wasn't having my usual allergy attacks. She put me on Singular and It's been 3wks now and I've been feeling worse than ever.

I took Singulair for about two years. I had developed these now known to be side effects but at the time nobody including the FDA was either aware or honest about the aggression, agitation and other side effects. I assumed this was all due to stress in my life and since it came on so gradually I did not put 2 and 2 together that it was the medication. I lived for two years being an irritable stressed out pain in the you know what struggling with these major aggressive compulsions. Then I saw a story on the news that the FDA was issuing this new warning on Singulair about the aggressive, anxiety and suicidal side effects of this drug. I stopped taking it that day. Luckily my asthma had been fairly well under control, I noticed no increase in asthma symptoms. What I did notice was I stopped being irritable and constantly annoyed and angry within a few days. I am back to being a mellow person, no problems since I quit this drug. I am horrified they are giving this to children. Both doctors and pharmacists should be warning people UP FRONT of this risk.

I've been on Singulair for a few weeks now and just put 2 and 2 together. Since starting this medication my nighttime asthma has improved but I have been very irritable. I have always been a stay at home mom and wouldn't have it any other way but lately I can't stand my children or my husband. They have been driving me crazy. Every little thing they do makes me want to scream. I just want to get out of the house. My husband also tells me I'm losing my mind. He says he has told me things and I have no recollection. I am currently breastfeeding my 10.5 month old who has also been very cranky lately. My 4 year old started Singulair around the same time as me and has been whinny all day and cries a lot. We are both stopping this medication today. I wish I had researched it before we started it.

I have been taking Singulair for one week now due to my exercise induced asthma and allergic asthmatic symptoms. I feel very stressed out and anxious and yell at my parents a lot. Also, I feel kind of paranoid, like I feel as if somebody is watching me at all times. It is scary because I've only been on it a week. Also, my face is red and blotchy and my acne has gone from very little bumps to full blown breakouts all over. I have a barking cough and runny nose now that the doctor prescribed it. When I cough I have a pain on my left side that feels like someone is stabbing me.

I have been on Singulair about 3 weeks and have been having mood swings, irritability, depression and nightmares. My doctor prescribed Singular after I complained about weight gain from Advair. I was diagnosed with asthma after having a bout with pneumonia last December 08.

Although Singulair has helped with my asthma symptoms, I have decided to stop using it after reading some of these postings.

I have been taking Singulair since November 08. Over the six months I noticed that I was suffering from depression and increased anxiety, plus an irregular heart rhythm. I experienced nightmares on an almost nightly basis. I have since stopped the medication - the nightmares have gone, the depression and anxiety improve everyday. Hopefully, this will also resolve the heart irregularities.

Tremendous weight gain almost instantly from age 7 to now at age 8-1/2 . When my grandson started this medication we noticed the weight gain. The doctor assured us it had nothing to do with the Singular. We looked on line for information, but could find nothing about weight gain as a side effect. At last it has surfaced that children taking the Singular are also having a weight gain problem. We intend to stop this medication immediately. This is intended for the health and well being of children.

Last Tuesday, my son was prescribed Singulair by our pediatrician. He was also prescribed Pulmicort by nebulizer at the same time. Within a couple of days, I was noticing a dramatic change in his personality. He's only 21 months old and normally a very happy, lovable, easygoing little boy. He did a complete 360. By Friday, I had to take a day off from work, as I was too scared to send him to daycare. He took his last Singulair chewable tablet on Friday night. Saturday was his worst day by far. I was in shock by his behavior. He was extremely aggressive, punching and slapping anyone who came near him, he was throwing things, throwing himself into walls, etc, just completely out of control. I contemplated even taking him to the hospital, but then started doing some research online. I had my mother contact a pharmacist whom we trust, who advised for us to stop the Singulair, as if he was having any side effect, it would more than likely be from that. On Sunday, I started to see some changes in him. Yesterday he was getting back to normal. Today, he's that much better. We actually went back to the pediatrician this morning and I'm actually thinking of filing a formal complaint against the dr. as he basically swore up and down that his side effects weren't from the Singulair. Well as a parent, does anyone really think I'd want to put my child thru this?? It may be different if he had behavioral issues prior to this, but this came completely from left field. I am beyond upset right now, pissed off that this drug can be on the market. How many children have to be affected??? This is very scary to me. My son was only on Singulair 4 days, and I feel guilty and angry that he had to go through even that short period of time on the drug. And then to have a pediatrician basically discount me and say that it has nothing to do with singulair is a complete slap in the face! I won't stop speaking out against this drug and hopefully it will inform other parents of these harmful consequences!!!!

My son now age nine went off Singulair two years ago. He was one it for about a year and was having terrible nightmares. I did not realize why until he went off of it. A year later the doctor put him back on it. I forgot and was not quite sure it was the Singulair so we tried again. About 2 months later it started again. I quickly remembered and took him off. When I asked the doctor I was told it is a rare side effect. I am happy to see this site so others know and can become aware. My daughter however has been on it for years and had done well. We are trying to take her off though because she seems very nervous and anxious (more than typical). I want to see if the medicine makes a difference.

Has anyone been in contact with any doctors, hospitals, or researchers who are willing to recognize that Singulair targets a receptor CysLT1, with known genetic variations? As you know, I have been posting that I know of researchers who are doing work about how the genetic variations can determine the efficacy of Singulair. If genetic variations cause differences in efficacy, then, of course, these variations can also cause unpleasant to very serious side effects. These seems to be some kind of disconnect. How can the genetic component be recognized in the area of efficacy and ignored in the area of adverse drug reactions?

My daughter has moderate asthma with occasional severe attacks. She's been on Singulair since she was 13; she is now 24. It has definitely helped her asthma a great deal, but now, when she misses a dose, or in the most recent event, she missed several days, she becomes allot more tight and has more difficulties sooner than it was like before she got on singulair at age 13. She is back on it now after being off for 5 days and is getting some relief. I wonder if her body has become dependent on it, or so accustomed to it that she now has to have it. A doctor a few years ago, said that means her asthma has gotten worse, but I suspect the dependency factor rather than her getting worse. Anyone have that experience?/

My daughter is 6 and has been on singulair for 2 years. Anytime we miss a pill she ends up with a fever of about 100 and is exhausted. Within a couple of days of her medicine it's gone again. The doctors think it's a complete coincidence but I don't agree.

I am so angry the more i think about this. This is my child and they are very selfish to mess with children's lives. but no matter how much i contest this drug the FDA will deny it all. Something needs to be done about this ASAP!
To see my child become paranoid over life and death and think hes dying everyday is heartbreaking.