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

Abstract

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.

Keywords: FAERS; disproportionality analysis; isotretinoin; monitoring priorities; pharmacovigilance; psychiatric adverse events.