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

This 21-year real-world analysis confirms that safety signals for PPS show a distinct long-latency risk profile, most critically vision-threatening maculopathy. The study highlights potential psychiatric adverse events not currently documented in the drug's label and reveals gender-specific risk profiles. These findings emphasize the need for vigilant, sustained ophthalmologic screening and broader safety monitoring for all patients receiving PPS therapy.