Lupus & antiphospholipid syndrome
Clinical adverse events to voclosporin: a real-world drug safety study based on FDA Adverse Event Reporting System
Authors' conclusion
The present research provides a significant assessment of the postmarketing safety profile of voclosporin.
Study context
- Population
- FDA adverse event reporting system (FAERS) reports, 2021Q4 to 2024Q3, with voclosporin as primary suspect drugreports
- Participants
- 11,851 reports
- Outcome
- Safety signals (AEs) associated with voclosporin
Methodological detailsdisproportionality analysis of FAERS, observational, FAERS 2021Q4 to 2024Q3, voclosporin as primary suspect drug, MedDRA preferred terms and SOCs
- Disproportionality analysis of FAERS
- Observational
- FAERS 2021Q4 to 2024Q3
- Voclosporin as primary suspect drug
- MedDRA preferred terms and SOCs
Main finding
As reported in the abstract
Disproportionality signals for voclosporin (PS drug) AEs in FAERS
- Reports with voclosporin as primary suspect (PS) drug
- 11,851
- Median time to onset of adverse events (AEs) (days)
- 54.50
- Hypertensive urgency (previously unreported), ROR (95%IC 11.53, 67.81)
- 27.96
- Hypertrichosis (previously unreported), ROR (95%IC 5.66, 40.65)
- 15.17
- Gingival swelling (previously unreported), ROR (95%IC 8.78, 30.57)
- 16.38
Observational data: associations, not effects.
Original publication
Clinical adverse events to voclosporin: a real-world drug safety study based on FDA Adverse Event Reporting System. Clin Exp Rheumatol. Published 23 February 2025. doi:10.
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