Singulair Side Effects Linked to Risk of Nightmares, Depression, Aggressive Behavior: Study

  • Written by: Martha Garcia

The findings of a new study highlight the potential side effects of Singulair, indicating that the popular asthma drug may increase an individual’s chance of suffering from nightmares, depression and aggressive behavior. 

Both adults and children who took Singulair (montelukast) frequently reported experiencing neurological side effects, according to research published in the medical journal Pharmacology Research & Perspectives on September 20.

The retrospective study looked at adverse drug reactions among both children and adults taking Singulair in the Netherlands. Reactions were reported to both the Netherlands Pharmacovigilance Center Lareb database and the World Health Organization Global database, VigiBase, until 2016.

Overall, depression was the most frequently reported Singulair side effect for both children and adults, as reported to the worldwide VigiBase. In only children, aggression was the most common side effect reported in VigiBase.

Headaches were reported most frequently to the Netherlands Pharmacovigilance Center database. Nightmares were often reported for both children and adults to both the Dutch and WHO worldwide database.

In 2013, the consumer watchdog group Public Citizen placed Singular on it’s “Do Not Use” list, highlighting the risk of nightmares, hallucinations, insomnia and other psychiatric problems, especially among children. The group also noted that the benefits of Singulair were minimal.

Among other side effects, the Dutch database indicated eight patients reported allergic granulomatous angiitis; whereas 563 reported the condition in the WHO VigiBase.

“These data demonstrate that montelukast is associated with neuropsychiatric adverse drug reactions such as depression and aggression,” the researchers concluded.

In 2009 the FDA ordered a Singulair warning label update, adding information about reports of suicide, suicidal thinking, aggression and other neuropsychiatric side effects.

Singulair belongs to a class of drugs known as selective leukotriene receptor antagonists. It is a pill taken orally once a day to treat asthma, exercise induced asthma and seasonal allergies. It is one of the top selling medications in the U.S., with sales of $3.5 billion in 2008.

Singulair is recommended and prescribed regularly for both children and adults. The manufacturer indicates common side effects include stomach pain, diarrhea, fever, flu-like symptoms, stuffy nose, sinus pain or headache. Other side effects may include skin rashes, ear pain or swelling, severe tingling, and changes in mood or behavior.

The effectiveness of Singulair is commonly debated. Some doctors believe it is not an effective treatment for asthma and other medications should be used instead, especially considering the widespread side effects.

A 2014 study indicated Singular did not prevent wheezing episodes among children who took the medication. In fact, children saw no improvement in wheezing episodes, compared to children who did not take the drug.

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  1. Lynne Reply

    This is not new news,there is a whole community of us on a facebook group,who for the last 9 years have been our only source of support and understanding,that these side effects are not rare,and can seemingly cause long lasting damage.Join our group and read in real time the heartbreak this drug has caused so many children and adults.Mostly the kids,what about the kids.This drug is know being trialed for serious brain diseases in adults,and yet daily a doc writes a script to a parent for their young child,without even one study on what it might do to the developing brain.My child took this drug for 3 years from age 11 to 15 and since then i have done as much as i can to help see what happened to him does not happen to another,but our hands are tied to some degree by big pharma the fda and the law itself,but believe me when i say children continue to suffer

  2. Julia Reply

    Lynn, what is the name of your Facebook group?

  3. Tekia Reply

    My child started bed wetting and began having an inability to control her bladder. She would literally run to the bathroom and urinate on the floor. The smell of medicine reeked from her pores and her urine became dark as well. When I brought this to her physicians attention they tried to have me brainstorm other reasons but it’s clearly a side effect that they didn’t tell me about and although my child drinks plenty of water and has been off the meds for over a week it’s only mildly better)the smell) she still sets. I pray it’s not a long term effect or that no liver/kidney damage was caused. I feel like they are trying to cover something up.

  4. Stephanie Reply

    My 7 year old son has severe non-verbal Autism and Intellectual Disability. He also has horrid seasonal allergies and what we suspect to be intermittent/mild asthma. His doctor prescribed montelukast to help manage those symptoms. My son took it for a month and it’s the worst parenting decision I ever made. He went from being a child with pretty mild behavior and ZERO self injurious behaviors to completely inconsolable. He started hurting himself, banging his head, hitting others, crying non stop, developed sleep disturbances and TREMORS. He is non verbal. He couldn’t tell me how he was feeling. I am ashamed to say that it took me a month to figure out that it was the montelukast prescribed for his allergies causing this devastating upset in his life. I am so angry. I feel like given his neurological and communicative disabilities I should have been made more aware of the side effects. We have been off the med for about 3 weeks and I have not yet seen a change in his behavior but the tremors have gone away.

  5. Katie Reply

    Hi, the Facebook support group is
    Montelukast (Singulair) Side Effects Support and Discussion Group

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