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
Clinical Scorecard: Psychiatric Adverse Events Associated with Roflumilast: An Analysis of the FDA Adverse Event Reporting System Data
At a Glance
Category Detail
Condition Chronic Obstructive Pulmonary Disease (COPD) Key Mechanisms PDE4 inhibition reduces airway inflammation and exacerbations. Target Population Patients with COPD receiving roflumilast. Care Setting Post-marketing surveillance.
Key Highlights
414 reports of roflumilast-related psychiatric AEs identified. Five significant positive signals: insomnia, suicidal ideation, sleep disorder, nervousness, and eating disorder. Increased risk of life-threatening events and hospitalization associated with psychiatric AEs. Guideline-Based Recommendations
Diagnosis
Monitor for psychiatric AEs in patients prescribed roflumilast. Management
Consider risk factors for psychiatric AEs when prescribing roflumilast. Monitoring & Follow-up
Regular assessment of mental health in patients on roflumilast. Risks
Increased risk of insomnia, suicidal ideation, and other psychiatric AEs. Patient & Prescribing Data
Patients with chronic obstructive pulmonary disease (COPD).
Approximately 2% of patients experience insomnia; psychiatric AEs include anxiety and depression.
Clinical Best Practices
Educate patients about potential psychiatric AEs associated with roflumilast. Implement routine mental health screenings for patients on roflumilast. Related Resources & Content
