Abstract
Background Isotretinoin is a 13-cis-retinoic acid most commonly used to treat severe nodular acne. It may result in psychiatric adverse events, such as completed suicide, even though the exact mechanism is unknown. Despite extensive research, the potential link between isotretinoin and psychiatric side effects remains unclear. Objectives The main objective of this study is to find the relationship between isotretinoin and suicide-related adverse events by analyzing the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Methods The study data were obtained from the FAERS database from 1982 to March 2024. The inclusion criteria were: (i) isotretinoin-related suicide and suicide-related adverse events; (ii) reports with specified age and gender. Out of the 73,076 extracted cases, 2839 were finalized for analysis based on the inclusion criteria. The data were represented as frequency and percentages. A chi-square or Fischer exact test was used to analyze the categorical variables. The P-value <0.05 was considered as statistically significant. Results As 2433 patients experienced multiple reactions, the reported suicide and suicide-related adverse events totalled 3,059. The most commonly affected individuals were males, with the exception of depression suicidal event, which was more common in females. Among all age groups, those aged 10-19 were the most affected, as the occurrence of acne and the use of isotretinoin were higher in this age group. Almost all the reactions were serious, and there were 349 completed suicides. Conclusion The usage of isotretinoin can increase the possibility of suicide-related adverse events and should be used cautiously, especially in adolescents and patients with previous psychiatric disorders.