The study analyzed data from the FAERS database on pentosan polysulfate sodium (PPS) adverse reactions from the first quarter of 2004 to the first quarter of 2025, identifying 11,471 reports where PPS was the primary suspect drug.[1][2][3] The most frequent and strongest signals were concentrated in the category of vision disorders, especially pigmentary maculopathy with an exceptionally high reporting odds ratio (ROR).[1][3] Significant non-ocular signals included depression and anxiety.[1] Analysis by gender showed that maculopathy occurred mainly in women, while men had more frequent gastrointestinal and urinary adverse events; the ratio of men to women was 1:12.32.[1][2] The median time to onset of adverse events (TTO, n=297) was 1,715 days, and a Weibull model (β=0.62) indicated a decreasing rate of risk over time.[1][2] The majority of reports (68.1%) were classified as serious adverse events.[1] The study confirms the long-term risk profile of vision-threatening PPS and emphasizes the need for ophthalmological monitoring.[1][3]