Reported psychiatric adverse events among isotretinoin users: Monitoring priorities from a 20-year FDA Adverse Event Reporting System database study.

BACKGROUND AND OBJECTIVE: Psychiatric monitoring during isotretinoin treatment may be warranted. However, beyond depression and suicide, it is unclear which psychiatric adverse events (AEs) should be prioritized for monitoring.

METHODS: Psychiatric AEs reported in FAERS from January 2004 to June 2024 were analyzed using disproportionality analysis, with reporting odds ratios >1 identifying positive signals. A clinical priority scoring system ranked the importance of these signals, and time-to-onset analysis evaluated their temporal patterns. Sensitivity analyses assessed the robustness of findings.

RESULTS: Among the 19,412 cases of isotretinoin-related psychiatric AEs, 50 positive signals included over 20 cases each. Twenty-five important signals were identified and grouped into categories of depressive disorder, suicide and self-injury, anxiety disorder, mood change, bipolar disorder, psychosis, and affective disorder. Acne patients exhibited more important signals compared to nonacne patients. The median time-to-onset for moderate-priority signals was 80 days (IQR: 31, 265), displaying an early failure-type pattern (α = 0.55, 95% CI: 0.54-0.56).

LIMITATION: Cross-sectional study.

CONCLUSION: Mood disturbances, suicide and self-injury, and psychosis are key psychiatric AEs that require focused monitoring, particularly among acne patients. Intensified early monitoring, followed by continuous assessment, may help reduce the harm associated with these events.