An exploratory study evaluating the 20 medications most commonly associated with suicidal ideation and self-injurious behavior in the FAERS database

Abstract

Background: A number of pharmaceuticals, including antidepressants and antiepileptics, have a strong correlation with suicide risk. However, it is not entirely clear which of these medications are more strongly associated with suicide-related behaviors.

Objective: This study aims to elucidate the drugs responsible for drug-associated suicidal ideation or self-injurious, recognizing the severe consequences associated with such outcomes. However, it is not entirely clear which specific medications are associated with higher levels of suicide-related behavior. Real-world data from the FDA adverse event reporting system database were analyzed to identify medications correlated with suicidal ideation or self-injurious.

Methods: The reporting intensity of the High-Level Term "suicidal ideation or self-injurious behavior" and its Preferred Terms across distinct categories was assessed using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR).

Results: We identified the top 20 drugs with the highest reporting frequencies, spanning sedative-hypnotics, antidepressants, antipsychotics, antiepileptics, antihypertensives, antipyretic/analgesic drugs, and antihyperglycemic drugs. Ranking these medications according to ROR, the top five medications with ROR values related to suicidal ideation or self-injurious were alprazolam, zolpidem, amphetamine, quetiapine, and fluoxetine. Further analysis showed that suicide-related adverse events were more frequently reported in females. Antiepileptics had the highest frequency of reported adverse events in the 51-55 year age group, compared to 16-20 years for antidepressants and 46-50 years for sedative-hypnotics.

Conclusion: Our study provides valuable information for clinical drug selection by presenting a potential list of medication classes commonly associated with drug-associated suicidal ideation or self-injurious behavior. We observed a large number of adverse event reports of suicidal ideation with duloxetine and relatively few reports of suicide attempts. Acetaminophen and amlodipine had substantial adverse event reports of completed suicides, but may not be associated with drug-induced suicidal behavior. On the other hand, some drugs mentioned in this study, such as quetiapine, aripiprazole, and lamotrigine, are recommended to be used after assessing the risk level of suicide in patients.

Keywords: Disproportionality analysis; FAERS; Pharmacovigilance; Self-injurious; Suicidal ideation.

Fig. 1

Top 20 medications associated with suicidal ideation or self-injurious behavior from FAERS arranged by frequency

Fig. 2

Gender and age distribution of suicidal and self-injurious behavior AEs associated with antiepileptics, antidepressants, and sedative-hypnotics. a Histogram of gender distribution. b Histogram of age distribution

Fig. 3

Reporting time distribution of suicidal and self-injurious behavior AEs associated with antiepileptics, antidepressants, and sedative-hypnotics. a–c Histogram of reporting time distribution for antiepileptics, antidepressants, and sedative-hypnotics

Fig. 4

The outcomes of antidepressants, antiepileptics, and sedative-hypnotics

Fig. 5

Onset time for antiepileptics, antidepressants and sedative-hypnotics. a Analysis flow of Onset time. b–d Histogram of Onset time distribution of antiepileptics, antidepressants, and sedative-hypnotics. e–g Cumulative curves of onset time for antiepileptics, antidepressants, and sedative-hypnotics