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Montelukast and Risk of Mental Health Side Effects

March 4, 2020

FDA adds a box warning for montelukast (Singulair® and generics) regarding the risk of mental health side effects (which may include suicidal thoughts or actions).

Montelukast (Singulair®) is a leukotriene inhibitor used to treat asthma and allergies.

The FDA is strengthening the mental health side effect warnings (including suicidal thoughts and actions) to be more prominently displayed as a boxed warning. Other common side effects of montelukast include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.

For Patients with Allergic Rhinitis

The FDA recommends that montelukast only be used in patients who have an inadequate response or intolerance to alternative therapies.

For Patients with Asthma

The FDA recommends that health care professionals consider the benefits and risks of mental health side effects before prescribing montelukast.

Report adverse events involving this or other medicines to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.