🇺🇸 Pentosan polysulfate sodium 100 mg in United States

FDA authorised Pentosan polysulfate sodium 100 mg on 26 September 1996 · 10 US adverse-event reports

Marketing authorisations

FDA — authorised 26 September 1996

  • Application: NDA020193
  • Marketing authorisation holder: JANSSEN PHARMS
  • Local brand name: ELMIRON
  • Indication: CAPSULE — ORAL
  • Status: approved

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FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Atrial Fibrillation — 1 report (10%)
  2. Atrial Septal Defect — 1 report (10%)
  3. Dilatation Ventricular — 1 report (10%)
  4. Dizziness — 1 report (10%)
  5. Dyspnoea — 1 report (10%)
  6. Electrocardiogram St-T Change — 1 report (10%)
  7. Fatigue — 1 report (10%)
  8. International Normalised Ratio Increased — 1 report (10%)
  9. Intracardiac Thrombus — 1 report (10%)
  10. Mitral Valve Incompetence — 1 report (10%)

Source database →

Pentosan polysulfate sodium 100 mg in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Pentosan polysulfate sodium 100 mg approved in United States?

Yes. FDA authorised it on 26 September 1996; FDA has authorised it.

Who is the marketing authorisation holder for Pentosan polysulfate sodium 100 mg in United States?

JANSSEN PHARMS holds the US marketing authorisation.