Spontaneous reporting systems are needed to detect and better characterize adverse events (AEs) with anaplastic lymphoma kinase (ALK) inhibitors in a timely manner in the real world.

Although rare, psychiatric disorders submitted to FAERS represent AEs of special interest with ALK inhibitors, the majority being serious, with probable causality.

This real-world pharmacovigilance study on marketed ALK inhibitors suggested that psychiatric AEs are adverse reactions to ALK TKIs, and raised the hypothesis of a class effect.