A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data

This real-world analysis confirms roflumilast's established adverse effects (gastrointestinal upset, weight loss, insomnia) and highlights concerning psychiatric signals. Most events occurred early, underscoring the need for close monitoring during treatment initiation. The use of multiple disproportionality methods enhances signal detection robustness and supports ongoing pharmacovigilance in clinical practice.