Psychiatric Outcomes After Isotretinoin

Original Article: Risk of Suicide and Psychiatric Disorders Among Isotretinoin Users: A Meta-Analysis

What are the key takeaways of this article?

This large meta-analysis aimed to clarify whether isotretinoin, a widely used treatment for severe acne, is associated with increased risk of suicide or psychiatric disorders. The study synthesized data from 25 observational studies involving over 1.6 million participants, analyzing both the absolute and relative risks of psychiatric outcomes including depression, anxiety, suicide ideation, suicide attempt, and completed suicide. The 1-year absolute risk of completed suicide, suicide attempt, and self-harm among isotretinoin users was consistently low, each below 0.5%, while the absolute risk of depression was estimated at 3.83%, comparable to the general population. In fact, isotretinoin users were found to be less likely to attempt suicide two to four years after treatment compared to non-users.

Importantly, isotretinoin use was not associated with a statistically significant increase in the relative risk of psychiatric conditions, including depression, anxiety, psychosis, and sleep disorders. The study also found that a history of psychiatric illness was a major risk factor for new psychiatric diagnoses or suicide attempts, while higher cumulative isotretinoin doses were associated with reduced risk of suicide attempt. Meta-regression analyses revealed that younger patients had a higher risk of depression, while male-predominant cohorts had a higher absolute risk of completed suicide, consistent with broader epidemiologic trends.

In summary, despite public concern and the FDA’s black box warning, this study found no epidemiologic evidence to suggest isotretinoin increases the risk of psychiatric disorders at a population level. However, the authors acknowledge that rare, idiosyncratic reactions may still occur in individual cases. They conclude that while isotretinoin appears safe for most patients, clinicians should continue to provide holistic psychodermatologic care and monitor for signs of mental distress throughout treatment.

Publication Date: November 21, 2025

Reference: Tan NKW, Tang A, MacAlevey NCYL, Tan BKJ, Oon HH. Risk of Suicide and Psychiatric Disorders Among Isotretinoin Users: A Meta-Analysis. JAMA Dermatol. 2024;160(1):54–62. doi:10.1001/jamadermatol.2023.4579

Summary By: Parsa Abdi