FDA Gives Asthma Drug Singulair a Black Box Warning for Mental Health Side Effects
Key takeaways:
Montelukast (Singulair) is a prescription medication that treats asthma and allergies in kids and adults.
Montelukast is generally well-tolerated. But it’s been linked to mental health-related side effects like depression, agitation, and thoughts of suicide. The FDA issued a boxed warning for these risks — their strongest medication warning.
If you have asthma or allergies, your healthcare provider will likely recommend trying other medications before trying montelukast. But if you need another option for relief, they may prescribe montelukast and monitor you for potential side effects.
In March 2020, the FDA issued a new safety announcement about montelukast (Singulair), a popular medication used by people with asthma and seasonal allergies. The FDA decided to add a new boxed warning (“black box warning”) to this medication. This is the most serious type of warning it can impose. This was due to several reports linking montelukast to potentially serious mental health side effects.
When allergy season comes into full swing, you or a loved one may be restarting montelukast. Or, you may already be taking it. If so, make sure to speak with your healthcare provider to fully understand the risks and benefits associated with montelukast — especially if you’re living with depression or anxiety.
What is montelukast used for?
Montelukast is an oral, prescription-only medication. It’s used to prevent and treat asthma in adults and children ages 2 years and older. It’s also used to relieve symptoms of allergic rhinitis. It works by blocking the effects of inflammatory chemicals called leukotrienes, which cause your airways to narrow or swell.
The FDA approved the brand version, Singulair, in 1998. The generic, montelukast, has been available since 2012.
What prompted the FDA’s decision?
This isn’t the first time the FDA has looked into the link between montelukast and mental health side effects.
In 2008 and 2009, Merck, Singulair’s manufacturer, updated the drug’s labeling four times to account for reported side effects of tremors, anxiousness, depression, and suicide. During this time, the FDA asked Merck to conduct more studies on the link between the drug and suicidal behavior.
More recently, the FDA re-evaluated monetelukast’s risks based on reports of suicide and other harmful side effects submitted to the FDA Adverse Event Reporting System (FAERS). They also conducted their own risk study and analyzed other published pieces of medical literature.
Based on these reassessments, the FDA decided to issue the strengthened boxed warning. They consulted an outside team of experts to help make this decision.
What are the mental health risks associated with montelukast?
Behavioral and mood-related side effects are possible with montelukast. Specifically, the FDA has issued warnings about side effects like:
Agitation and aggression
Irritability
Confusion
Hallucinations
Memory changes
New or worsening depression
Sleeping problems, including vivid dreams and sleepwalking
Suicidal thoughts and behaviors
Suicide
While rare, these are symptoms that you shouldn’t ignore. If you notice any changes in your thoughts and behaviors after starting or stopping montelukast, make sure to reach out to your healthcare provider right away. They can talk to you about next steps.
Other montelukast side effects
Although mood and behavioral side effects are possible with montelukast, they’re not common. What’s more, many people can take montelukast without experiencing any side effects at all.
These montelukast side effects are more likely to happen:
Headache
Cough
Upper respiratory infections, such as the common cold
Flu-like symptoms, such as a fever or sore throat
Stomach pain
Diarrhea
Thankfully, there are ways to help manage or prevent montelukast side effects like these. Following your healthcare provider’s dosing instructions as best as you can, taking the medication around the same time every day, and avoiding extra doses is a good starting point.
You can also ask your pharmacist about ways to manage specific side effects. For instance, they may recommend a specific over-the-counter (OTC) pain reliever if you develop a headache or fever.
However, if any symptoms feel severe, don’t go away, or get worse at any point, make sure to loop in your healthcare provider.
What should I do if I currently take montelukast?
Because of this updated safety warning, the risks of montelukast may outweigh the benefits for some people. If you’re currently taking montelukast, check in with your provider and ask about montelukast’s risks and benefits for you.
In general, you should only take montelukast if you can’t tolerate other medicines or they do not work for you. This is the case for both allergy medications and asthma medications.
Montelukast alternatives for allergies
There are several options for allergy relief aside from montelukast, many of which are available OTC. If you have allergies, some alternatives to montelukast are listed below.
Nasal sprays:
Fluticasone propionate (Flonase Allergy Relief)
Triamcinolone (Nasacort)
Budesonide (Rhinocort)
Azelastine (Astepro)
Oral medications:
Cetirizine (Zyrtec)
Loratadine (Claritin)
Fexofenadine (Allegra)
Levocetirizine (Xyzal)
Diphenhydramine (Benadryl)
Chlorpheniramine (Chlorphen-12)
Based on your specific allergy symptoms — and how often they happen — your pharmacist and healthcare provider can help you narrow down your options.
Montelukast alternatives for asthma
There are many asthma medications for you to choose from. Most of them are inhalers. Montelukast side effects aside, these inhalers are generally first-choice options for managing asthma symptoms. Common examples are Pulmicort Flexhaler (budesonide), Advair (fluticasone/salmeterol), and Symbicort (budesonide/formoterol).
Based on your age, symptom severity, and health insurance status, you can work with your provider to find an effective and affordable asthma treatment for your situation.
The bottom line
Montelukast is a prescription medication that treats allergies and asthma, but some reports have connected it to mental health side effects. Some people taking it have developed new or worsening agitation, depression, and thoughts of suicide. The FDA gave montelukast a boxed warning for these risks in 2020, sometimes referred to as the Singulair black box warning. While these risks are serious and real, they’re rare overall.
Why trust our experts?
For additional resources or to connect with mental health services in your area, call SAMHSA’s National Helpline at 1-800-662-4357. For immediate assistance, call the National Suicide Prevention Lifeline at 988, or text HOME to 741-741 to reach the Crisis Text Line.
References
Dr. Reddy's Laboratories Limited. (2022). Montelukast sodium- montelukast sodium tablet, coated. Montelukast sodium- montelukast sodium tablet, chewable [package insert].
Dykewicz, M. S., et al. (2020). Rhinitis 2020: A practice parameter update.
Global Initiative for Asthma. (2022). Global strategy for asthma management and prevention (2022 update).
Sentinel Initiative. (2019). Neuropsychiatric events following montelukast use: A propensity score matched analysis.
The Associated Press. (2008). U.S. to study drug for suicide links. The New York Times.
U.S. Food and Drug Administration. (2020). FDA requires boxed warning about serious mental health side effects for asthma and allergy drug montelukast (singulair); advises restricting use for allergic rhinitis.
U.S. Food and Drug Administration. (2023). Potential signals of serious risks/new safety information identified from the FDA adverse event reporting system (FAERS).
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