Neuropsychiatric adverse events of chloroquine: A real-world pharmacovigilance study using the FAERS database

Kenichiro Sato; Tatsuo Mano; Atsushi Iwata; Tatsushi Toda

In this study, we investigated reports of neuropsychiatric AEs that were developed following exposure to chloroquine as a treatment for malaria or autoimmune diseases. The major strength of our study is that it was based on a database that includes global real-world data from a very large number of patients. Our results showed a statistically significant association (albeit marginal) between the use of chloroquine and the reporting of LOC, amnesia, delirium, hallucination, and depression, however, there was no statistically significant association between the use of chloroquine and the reporting of suicide, psychosis, confusion, or agitation, suggesting that there is no link between the use of chloroquine and the increased risk of these AEs. Conversely, mefloquine showed to be associated with statistically significant high reporting of most of the neuropsychiatric AEs, which is consistent with some of the earlier literature reports [12, 19] .