Singulair and Depression

Many side effects are possible with Singulair, and depression may be one of them, although the frequency with which this occurs is unknown. It was not reported in clinical studies conducted before the drug's approval, and has only been reported since then. If you are taking Singulair and depression symptoms occur, it's important to let your healthcare provider know so that treatment can be obtained.

 

Is Depression a Singulair Side Effect?

Several side effects are possible during treatment with Singulair® (montelukast sodium), and depression may be one of them.
 
In clinical studies of Singulair before it was approved, depression was not reported as one of the possible Singulair side effects. However, since the drug has been approved, there have been reports of depression in people taking it.
 

Singulair and Depression: Understanding Clinical Trials

Before most medicines are approved, they must go through several clinical studies, where thousands of people are given a particular medicine and compared to a group of people not given the medicine. In these studies, side effects are always carefully documented. This way, it is possible to see what side effects occur, how often they appear, and how they compare to the group not taking the medicine.
 
In clinical trials, depression was not reported as a side effect of Singulair. After a medication is approved and marketed, however, the manufacturer is required to keep track of side effects reported to them by patients or healthcare providers. Since Singulair was approved, depression has been reported as a possible side effect of the drug. But, because not all cases of depression are reported, it is impossible to tell exactly how commonly (or how rarely) depression occurs in people taking it.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;