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Montelukast's Side Effects
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ADDITIONAL INFORMATION FOR PARENTS AND CAREGIVERS FROM
FDA'S MARCH 3, 2020 COMMUNICATION ABOUT MONTELUKAST

Serious mental health side effects have occurred in patients with and without a history of mental illness.

Talk with your health care professional about the benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available, including over-the-counter ones, without a prescription.

Stop taking montelukast and notify a health care professional right away if you or your child experience behavior or mood-related changes while taking the medicine.

Talk to your health care professional about any history of mental illness before starting treatment.
If you have allergies, there are a number of steps you can take to lessen your symptoms. These include avoiding exposure to allergy triggers, keeping indoor air clean, and taking allergy medicines.

We are requiring a new patient Medication Guide, which you should read every time you receive a prescription for montelukast. The Medication Guide explains the mental health risks and other important things you need to know about the medicine. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.Talk to your health care professional if you have any questions or concerns.

To help FDA track safety issues with medicines, report side effects from montelukast or other medicines to the FDA MedWatch.

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Disclaimer: Parents United for Pharmaceutical Safety and Accountability is a volunteer patient advocacy group. Consult a licensed healthcare professional before making any medical decisions. Do not stop administering an asthmatic child's medications without the supervision of the child's healthcare provider. The information on this site is intended for educational purposes and should not be construed as medical advice. It is accurate to the best of our knowledge. If you discover an inconsistency, please bring it to our attention.