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Singulair Black Box Warning

The U.S. Food and Drug Administration issued a Singulair black box warning in 2020 because of potentially serious behavior and mood-related changes with Singular. These changes include depression and suicidal thoughts. People experiencing behavior or mood-related changes should contact their doctor.

Last Modified: September 7, 2023
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What Is the Black Box Warning for Singulair?

The U.S. Food and Drug Administration approved montelukast, the active ingredient in Singulair, to treat asthma and allergies. However, it issued a boxed warning after reviewing evidence of serious behavior and mood-related side effects of Singulair.

The boxed warning, formerly called a black box warning by the FDA, advises that patients be monitored for neuropsychiatric side effects while taking Singulair and discontinue the medication if they occur.

Why Is There a Boxed Warning for Singulair?

Montelukast prescribing information already included warnings about mental health side effects. However, many health care professionals and patients were not aware of the risks. The FDA issued the boxed warning after reviewing evidence of mental health side effects of Singulair.

These side effects may include agitation, depression, suicidal thoughts and behavior changes. In many cases, these resolve after stopping Singulair. However, they may persist even after discontinuing use of the medication.

The FDA’s decision came after conducting a thorough review of existing data and consulting outside experts. Further investigation is needed to better understand the extent and nature of Singulair side effects.

People who were diagnosed with a mental health disorder after taking Singulair are filing lawsuits against the drug's manufacturer.
View Lawsuits

What Do I Do if I Experience Singulair Side Effects?

If you experience Singulair side effects, speak with your doctor immediately. If you or someone you know is experiencing suicidal thoughts, contact the National Suicide Prevention Lifeline at 1-800-273-TALK (1-800-273-8255) or visit their website. In the case of an emergency, seek immediate medical attention.

If you have been injured as a result of Singulair side effects, consulting with an experienced attorney can help you explore your options for compensation. People who have been injured have filed Singulair lawsuits pursuing compensation for medical expenses, lost wages, pain and suffering.

Are There Singulair Alternatives?

For some people, the risk of Singulair side effects may not outweigh its benefits in treating asthma and allergies, especially when symptoms are mild. For those concerned about the risks of Singulair or who have experienced Singulair side effects, there are other medications available for treating asthma and allergies.

Some common Singulair alternatives include:
  • Advair (asthma)
  • Allegra (allergies)
  • Claritin (allergies)
  • Flonase (allergies)
  • Loratadine (allergies)
  • Prednisone (asthma and allergies)
  • Promethazine (allergies)
  • Symbicort (asthma)
  • Xolair (asthma)
  • Zyrtec (allergies)

Speak with your health care provider to explore your treatment options. To ensure safe and effective management of your symptoms, always consult your doctor before discontinuing Singulair or starting a new medication.

Please seek the advice of a medical professional before making health care decisions.