Psychiatric events induced by roflumilast: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System database - Takeaways - MDSpire
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Psychiatric Adverse Events Associated with Roflumilast: An Analysis of the FDA Adverse Event Reporting System Data

  • By

  • Lifang Wu

  • Yan Chen

  • Yaping Huang

  • Shaojun Jiang

  • Chengjie Ke

  • June 11, 2026

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  • 1

    Roflumilast is approved for treating chronic obstructive pulmonary disease but has limited post-marketing psychiatric safety data.

  • 2

    The study identified 414 reports of psychiatric adverse events associated with roflumilast, highlighting 31 preferred terms.

  • 3

    Five significant psychiatric adverse events were identified, including insomnia, suicidal ideation, and sleep disorders.

  • 4

    The analysis indicated an increased risk of life-threatening outcomes and hospitalization due to psychiatric adverse events.

  • 5

    Findings aim to inform healthcare professionals about psychiatric risks associated with roflumilast to improve clinical decision-making.

Original Source(s)

Psychiatric events induced by roflumilast: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System database

  • by Lifang Wu, Yan Chen, Yaping Huang, Shaojun Jiang, Chengjie Ke

  • June 11, 2026

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