Singulair’s Black-Box Warning – ‘Honest Medicine’ Check-In

  • Singulair’s Black-Box Warning – ‘Honest Medicine’ Check-In

    Posted by IMA-HelenT on November 19, 2025 at 2:16 pm EST

    I keep seeing posts on social about neuropsychiatric side-effects tied to Singulair (montelukast). I’ll admit up front: I haven’t dug into every study yet, but what really jumps off the screen is how many parents and patients say they were never warned that this drug has carried an FDA black-box warning since 2020 (and red-flag data were around as far back as 2008!).

    Why do we still see these horror stories week after week?

    A couple of questions for the community

    Your Experience : Were you (or your child) prescribed Singulair or its generic without any mention of the black-box risk? How did you find out?

    Side-Effects Timeline : If you noticed mood changes, anxiety, or worse, how quickly did your prescriber connect the dots?

    ⚠️ Reminder: If anyone you know is on montelukast and shows any mental-health shifts, most guidelines now say stop immediately and contact a professional.

    It’s past time we held the system to its own “do no harm” standard…patient safety shouldn’t be optional.

    IMA-HelenT replied 4 months, 2 weeks ago 2 Members · 2 Replies
  • 2 Replies
  • Dr. Wawa

    Member
    November 20, 2025 at 2:10 am EST

    Singulair (monolucast) has been causing manic episodes for at least several decades–hence the warning box.

    I am a psychiatrist. I have seen patients over three decades who became manic on monolucast–hence the warning box. Lithium works well.

    • IMA-HelenT

      Organizer
      November 20, 2025 at 10:53 am EST

      Thank you @dr-wawa for weighing in on the conversation.

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