(417) Postmarket Safety Profile of Daxxify: A Review of the FDA Adverse Event Reporting System Database

Introduction: Daxxify (DaxibotulinumtoxinA-lanm) is a recently approved long-acting botulinum toxin used for aesthetic indications, with limited post-marketing safety data to date. This study evaluates reported adverse events associated with Daxxify using the FDA Adverse Event Reporting System (FAERS) to assess the early real-world safety profile.

Methods: This retrospective database study queried the FAERS database for reports involving Daxxify from initial post-approval reporting in 2023 to 2025. Reported adverse events (AEs) associated with aesthetic botulinum toxin use were evaluated using national pharmacovigilance data. Duplicate reports were removed, and analyses were limited to healthcare professional-submitted cases. Outcomes included the type and severity of reported adverse events, summarized using descriptive analyses to assess post-marketing safety trends.

Results: A total or 1072 AEs were reported across 767 unique cases, with the highest proportion of reports occurring in 2024 (364 cases, 47.5%), followed by 2025 (28.0%) and 2023 (24.5%). AEs were reported using MeDRA system organ class terminology, with most frequently represented category being injury, poisoning, and procedural complications (607/2072, 56.6%). Off-label use was noted in 593 cases (77.3%). Reports of treatment ineffectiveness were common, including drug ineffective for unapproved indications (160 cases, 20.9%) and general drug ineffectiveness (102, 13.3%), with underdosing reported in 103 cases (13.4%). The most commonly reported clinical AEs included eyelid ptosis (97, 12.7%), headache (53, 6.9%), injection site pain (48, 6.3%) and swelling (46, 6.0%), and blurred vision (31, 4.0%). Most reported events were localized and consistent with known botulinum toxin-related effects.

Conclusions: Daxxify demonstrates an early post-marketing safety profile dominated by expected, localized adverse events, with frequent reports of ineffectiveness and procedural complications. Comparative studies with Botox are needed to further define its real-world safety profile.