FAERS Safety Signals for Perfluorohexyloctane Ophthalmic Solution, Q4 2023–Q4 2024

A retrospective pharmacovigilance study using FDA Adverse Event Reporting System (FAERS) data from the fourth quarter of 2023 through the fourth quarter of 2024 identified 92 adverse event reports associated with perfluorohexyloctane ophthalmic solution for dry eye disease. The analysis employed four disproportionality methods to detect safety signals, with a median time-to-onset of 2 days for reported events. The dataset was authored by Zhengtai Sun and shared under a CC-BY-4.0 license.

Use Cases

• Identify common adverse events associated with a novel ophthalmic drug based on FAERS reports
• Assess the time-to-onset profile for drug-related adverse events based on the reported median of 2 days
• Compare safety signals across different disproportionality analysis methods (ROR, PRR, BCPNN, MGPS)
• Evaluate the nature of reported events (e.g., instillation process vs. drug effect) for risk management

Strengths

• Focuses on a specific drug (perfluorohexyloctane ophthalmic solution) and indication (dry eye disease)
• Employs four established pharmacovigilance signal detection methods (ROR, PRR, BCPNN, MGPS)
• Reports a specific median time-to-onset of 2 days for adverse events

Limitations

• Row count is unknown, which may limit suitability assessment
• Column-level documentation is absent; field semantics must be inferred after download
• The dataset is very small (11.4 KB), indicating limited scope

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective disproportionality analysis of spontaneous reports

Time Range

Q4 2023 to Q4 2024

Freshness

Last updated 2026-05-28 04:48:11; freshness should be verified