Post-marketing safety of pentosan polysulfate sodium: a 21-year pharmacovigilance analysis of the FAERS database

Wang B, Xia L, Bao EH, Zheng YB, Li YH, Han D, Shao TY, Liu XZ, Zhu PY · Frontiers in Medicine

What two decades of spontaneous reports look like: eye disorders dominate both the volume and the signal strength, with pigmentary maculopathy at an exceptionally high reporting odds ratio; 68.1% of reports were serious; and median time to onset was 1,715 days — about four and a half years — with a decreasing hazard shape. Depression and anxiety appeared as signals not carried on the label.

Population

11,471 FDA Adverse Event Reporting System reports with PPS as primary suspect drug, 2004 to early 2025

Intervention

PPS in routine use, overwhelmingly oral

Comparator

Background reporting for all other drugs (disproportionality analysis)

Limitations

Spontaneous reporting cannot give incidence and is distorted by publicity — the maculopathy signal became widely known during the period analysed; no denominators, no dose data, and a published correction to the article followed in 2026.