Purpose

To characterize adverse events (AEs) associated with dermal fillers and compare AE profiles between hyaluronic acid (HA) and calcium hydroxyapatite (CaHA) fillers using a national pharmacovigilance database.

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Methods

This retrospective cross-sectional pharmacovigilance study included 294 AE reports from the US Food and Drug (FDA) Adverse Event Monitoring System (AEMS), comprising 265 HA-based filler and 30 CaHA-based filler reports. Reports from healthcare professionals pertaining to cosmetic indications were identified and classified into 12 anatomical and clinical AE categories. Reporting odds ratios (RORs), Fisher’s exact test, and McNemar test were performed.

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Results

Injection site-related AEs were the most frequently reported (n=175/294, 59.5%), followed by product-related (n=110/294, 37.4%) and systemic events (n=100/294, 34.0%). Most AEs were non-serious (n=231/294, 78.6%). Ocular AEs occurred in 6.8% of reports (n=20/294) and were significantly more frequent in the CaHA group than the HA group (16.7% vs. 5.7%; ROR=0.30 relative to HA as reference; p<0.05). CaHA reports showed higher rates of ocular sensory and irritative symptoms (16.7% vs. 2.6%; ROR=0.17; p<0.01). Procedural error was also more frequent in CaHA reports (20.0% vs. 6.4%; ROR=0.27; p<0.05).

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Conclusion

Most dermal filler AEs are mild and injection site-related. Ocular complications were disproportionately reported with CaHA-based fillers, underscoring the importance of preventive strategies and careful injection technique in aesthetic practice.

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Additional Authors

First name	Last name	Base Hospital / Institution
Merve	Kulbay	McGill University
Mathilde	Gallant	McGill University
Anton	Volniansky	McGill University
Stuti Misty	Tanya	McGill University
Femida	Kherani	University of British Columbia

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