Should I Be Worried About Potential Mood-Related Side Effects With Singulair?
Key takeaways:
Singulair (montelukast) is an oral, prescription-only medication that treats asthma in people age 12 and older, and allergies in adults and children age 2 and older.
In 2020, the FDA issued Singulair a boxed warning — their strongest medication warning — because of a risk of potentially serious behavior- and mood-related changes, including depression and suicidal thoughts among adults and children.
Here’s how three people describe their reaction to the warning and their experience with taking Singulair.
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Montelukast is a popular allergy and asthma medication that’s been on the market under the brand name Singulair for more than 25 years. It’s a prescription-only medication that comes in both pill and chewable form. Today, it’s still one of the most widely used allergy and asthma treatments in the world.
But in 2020, the FDA issued a boxed warning — formerly known as a “black box” warning — the agency’s strongest medication warning. The reason for the warning is the risk for potentially serious behavior- and mood-related side effects with the medication, including depression and suicidal thoughts among adults and children. In recent months, some people have filed individual or class-action lawsuits because they were not adequately warned about the medication’s serious risks.
The boxed warning made some people who take it — or whose kids take it — second guess relying on Singulair (or generic montelukast) as their go-to allergy and asthma medication. Here’s how three people describe what it’s been like for them.
Did Singulair make her depression worse?
Amy McKeown is concerned. The 49-year-old Raleigh, North Carolina, swim instructor has been taking Singulair since at least 2008. But in January 2024, Amy noticed a flurry of news reports about the medication’s possible side effects — including night terrors, anxiousness, and suicidal thoughts.
The reports made Amy wonder about the cause of her own depression. So one week in early March 2024, she stopped taking Singular. Four days later, her mood brightened: “It was literally like a weight being lifted off my shoulders,” she says.
![“[Stopping Singulair] was literally like a weight being lifted off my shoulders.” — Amy McKeown](http://www.grxstatic.com/4f3rgqwzdznj/1pyP3g58mgJdXV6F07okWy/a32883a85308e40c67df5046de0e1658/patient_stories_feel_siingulair_quote_1.png?format=png&auto=webp&width=704)
Amy, who has major depressive disorder, says she thinks Singulair made her symptoms worse. March 2024 wasn’t the first time she’d felt happier after she stopped taking her daily dose. In 2023, there was a 6-month period when she was without insurance coverage for prescription medications. But, back then, her positive mood was offset by other things, including a bout with cancer and post-pandemic financial burdens.
“There were just other things going on,” she says. “But, you know, I’m over the cancer now, and financially, I’m OK. So why was I still depressed? Why do I still have this dark cloud over me? I’m back in the pool. I’m exercising again. It was like, ‘Am I really that messed up?’”
It was around the time she was asking herself these questions that the steady stream of news articles about Singulair’s side effects caught her attention.
“It finally just sort of clicked and I said, ‘OK, well, I’m going to stop taking it.’ And the difference was almost overnight,” Amy says, referring to an improvement in her depression symptoms, bad dreams, and thoughts of self-harm. “After about 4 days, I haven’t had a single thought like that, so I’m wondering if maybe it is related.”
While she says Singulair has been great for her asthma, Amy is holding off on taking it until she can meet with her doctor and find out if there is indeed a connection. Until then, she says she hopes her Albuterol inhaler and other asthma and allergy medications will be enough to ease her symptoms.
Managing medication interactions: Find expert answers to 5 commonly asked questions about Singular (montelukast) interactions.
What to expect: Here’s what experts say about managing Singular’s side effects.
Decoding labels: What does an FDA boxed warning mean?
Being happy to ‘go out and breathe and be normal again’
Ann Kimble-Hill, 45, says she has never experienced any negative side effects from Singulair, and credits the medication for making Midwest living a literal breath of fresh air. The Chicago native moved to Indianapolis about 15 years ago, and though only about 185 miles separate the two cities, for Ann, they’re worlds apart during allergy season.
“You wouldn’t think it would be that big of a shift, but they have grasses and trees here [in Indianapolis] that we didn’t have in Chicago,” Ann says.
Before the move, Ann kept her asthma at bay with antihistamines and an inhaled steroid. After the move, everything changed.
“I was struggling,” says Ann, a biochemist and faculty member at the Indiana University School of Medicine. “Indiana has a ton of new allergens that I had never experienced and never been exposed to before. The first summer we moved here, I remember walking outside. I was so excited. I love to be outside. But my skin just started turning red and it was itching, and I’m, like, ‘What the heck is this?’”
“This” was an allergic reaction that made her asthma even worse. Her allergist added Singulair to the list of medications Ann was already taking to treat both her asthma and allergies, and it made a difference within the first few days. “For me, it was a relief just to be able to go out and breathe and be normal again,” Ann says.
As a biochemist, Ann is curious about what in the medication’s formulation might point to an increase in depression and suicidal tendencies in some people. For her, Singulair has worked wonders.
“It’s been a great complement to my overall well-being — with my allergies as well, not just breathing and asthma,” she says.
Concerns over her daughter’s health
Courtney Boyce’s daughter, Nevaeh, was diagnosed with asthma when she was 2 years old and has been taking Singulair every day since age 6 or 7. She’s now 13, and her mother suspects the medication might be at the root of Nevaeh’s years of stomach pain and mental health challenges.
When Nevaeh first started taking Singulair in its chewable form, things seemed fine, Courtney says.
“I mean, it helps with asthma. That’s the main reason we take it,” she says. “It has the allergy component in it as well, and we still have to use other allergy medications because her allergies are pretty bad.”
As she grew older, however, Nevaeh started dealing with anxiety, depression, and stomach pain. “Her anxiety is so bad right now,” Courtney says, adding that her daughter also has attention-deficit hyperactivity disorder (ADHD).
When Courtney learned of the many recent news reports about Singulair’s side effects in children, she wondered if the medication that helped her daughter’s asthma was also harming her mental health.
“It’s all making sense,” says Courtney, a 36-year-old Raleigh, North Carolina, optician. “Stomach pain, anxiety, and depression are side effects, and she was literally calling me from school every single day, and nobody could find anything wrong.”
Courtney says she plans to contact Nevaeh’s pediatrician to see if there is any reason to believe any of her daughter’s health issues trace back to Singular. “I mean, she’s got a lot of different diagnoses, but if this is making it worse, I don’t want her on it,” she says.
What does the pharmacist say?
Alyssa Billingsley, PharmD
Senior Director, Pharmacy Content
Singulair (montelukast) is an oral medication that’s used to manage and prevent asthma symptoms and to provide relief for allergy symptoms. It belongs to a class of medications called leukotriene receptor antagonists. These medications work by blocking the effects of leukotrienes — inflammatory chemicals in the body that cause airways to tighten.
Singulair isn’t typically a first-choice medication for asthma or allergies. But it can be a helpful addition when other treatments aren’t working well enough. And if you deal with asthma and allergies, it can tackle those symptoms at the same time.
Some people taking Singulair report mild side effects. These can vary slightly based on age and use, but common examples include upper respiratory tract infections, fever, headache, and abdominal pain.
While uncommon, Singlair has also been linked to serious behavior- and mood-related side effects. These side effects can include aggressiveness and agitation, depression, and bad or vivid dreams. In severe cases, suicidal thoughts and behaviors have been reported. As a precaution, the FDA has given Singular its strictest warning — called a boxed warning — to call attention to these potential side effects. When you pick up your Singulair prescription from the pharmacy, you should receive a medication guide that provides information on these side effects.
If you or a loved one are taking Singulair and have noticed changes in your mood or behavior, contact your healthcare team right away for guidance about next steps. They can help you determine if the symptoms may be because of Singular or another cause.
You should also reach out to your care team if you have questions about Singulair side effects, even if you aren’t experiencing any. Keep in mind that, while Singular’s potential mental health side effects may sound scary, they don’t appear to be common. But it’s important that you understand the possible risks and feel comfortable taking Singular.
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