Differences in ocular adverse events associated with phosphodiesterase-5 inhibitors: a real-world pharmacovigilance study

ABSTRACT

Objective

Our study aims to characterize the ocular safety profiles of phosphodiesterase type 5 (PDE5) inhibitors and explore the differences among different PDE5 inhibitors.

Methods

We analyzed reports on ocular adverse events associated with sildenafil, vardenafil and tadalafil submitted to the FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the first quarter of 2023. Disproportionality analysis was conducted to evaluate reporting risk profiles.

Results

Among 61,211 reports qualifying for analysis, 5,127 involved sildenafil, 832 vardenafil, and 3,733 tadalafil. All PDE5 inhibitors showed increased reporting odds ratios (ROR) for ocular adverse events, with vardenafil highest (ROR 4.47) followed by sildenafil and tadalafil. Key ocular adverse events included cyanopsia, optic ischemic neuropathy, visual field defects, unilateral blindness and blindness. Sildenafil showed the highest disproportionality for cyanopsia (ROR 1148.11) while vardenafil and tadalafil showed the highest disproportionality for optic ischemic neuropathy. Time-to-onset analysis also revealed significant differences, with sildenafil having a later median time-to-onset compared to vardenafil and tadalafil.

Conclusions

This comprehensive pharmacovigilance study reveals distinct patterns of ocular adverse events associated with PDE5 inhibitors. These findings contribute to a better understanding of the safety profiles of PDE5 inhibitors and may guide healthcare professionals in clinical decision-making.

KEYWORDS:

• Phosphodiesterase-5 inhibitors
• ocular adverse events
• disproportionality analysis
• pharmacovigilance analysis
• FAERS

Declarations of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributors

Conceptualization: Z Fu, and G Chen. Collected and analysis the data: Z Fu, G Chen, L Zhang, and S Zhao. Writing-original draft manuscript: Z Fu, G Chen. Figure preparation: Z Fu, G Chen, and H Huang. Final editing: Z Fu and G Chen. All authors have read and approved the submission of the manuscript.

Availability of data and material

This research was based on legally obtained anonymized data from the FAERS database on the FDA website, freely accessible to all the medical researchers. Therefore, ethical approval and consent for publication was not required.

Additional information

Funding

This paper was not funded.