RAISR4D Suicide

Analysis of risk signals for Viloxazine in the treatment of attention deficit hyperactivity disorder based on the FAERS database

25/04/2025

J Affect Disord. 2025 Apr 22:S0165-0327(25)00661-5. doi: 10.1016/j.jad.2025.04.087. Online ahead of print.

ABSTRACT

OBJECTIVE: Viloxazine is a novel non-stimulant medication for treating attention deficit hyperactivity disorder (ADHD), this study aims to systematically analyze various adverse event (AE) signals related to Viloxazine using data from the FAERS database.

METHODS: Reports of AEs related to Viloxazine were retrieved from FAERS (Q2 2021 to Q2 2024). Signal detection methods were used to calculate signal strength, categorizing events by system organ class (SOC) and preferred terms (PT).

RESULTS: Out of 16,392,056 AE reports, 546 involved Viloxazine as the primary suspect drug. FAERS signal mining identified 64 PT signals across 23 SOCs. Common AEs included psychiatric and nervous system disorders, such as suicidal ideation (EBGM = 29.51), anxiety (EBGM = 3.47), irritability, and headache. Gastrointestinal disorders and systemic reactions were also noted. Novel AEs with strong signals included behavioral disorders (e.g., panic attacks, homicidal ideation), metabolic abnormalities (e.g., abnormal skin odor), and neuromuscular dysfunctions (e.g., dystonia). Hyperacusis (EBGM = 54.04) and photophobia (EBGM = 16.07) suggested sensory processing impacts. Most AEs occurred within 30 days of treatment initiation.

CONCLUSION: Viloxazine has shown efficacy and tolerability but poses potential safety risks, particularly regarding mood, behavior, and sensory processing. Ongoing monitoring and further studies are needed.

PMID:40274110 | DOI:10.1016/j.jad.2025.04.087

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