Elmiron FDA Adverse Event Reports (2026): FAERS Data Summary

How many Elmiron adverse event reports has the FDA received

As of July 21, 2026, the FDA Adverse Event Reporting System (FAERS) contains 6,854 public reports in which Elmiron (pentosan polysulfate sodium) is listed as a suspect or concomitant drug. Of these, 4,802 reports (70.1%) were classified as serious, and 110 involved a reported death outcome. These figures come directly from the openFDA public API and update as new reports are processed.

Elmiron FAERS reports by year

Recent yearly report volumes for Elmiron (pentosan polysulfate sodium) in FAERS: . Report counts reflect when the FDA received each report, not when the adverse event occurred, so recent years may still rise as processing continues.

What side effects are most reported for Elmiron

The most frequently reported reaction terms for Elmiron in FAERS are: Maculopathy (1,391 reports); Off Label Use (1,389 reports); Retinal Pigmentation (607 reports); Dry Age-Related Macular Degeneration (560 reports); Pigmentary Maculopathy (457 reports); Drug Ineffective (343 reports); Pain (304 reports); Product Use Issue (272 reports). Reaction terms follow MedDRA coding as submitted by reporters, and a single report may list multiple reactions.

Do FAERS reports prove the drug caused the injury

No. FAERS is a spontaneous reporting system: anyone can submit a report, reports are not verified for causation, and the existence of a report does not establish that the drug caused the event. Report volumes are also influenced by publicity and litigation activity. FAERS data is best used as a signal, alongside clinical studies and regulatory findings.

How to cite this data

Source: U.S. FDA Adverse Event Reporting System (FAERS), retrieved via the openFDA API on July 21, 2026. Query: reports listing pentosan polysulfate sodium. You are welcome to cite the figures on this page with a link back to this summary; the underlying raw data is public at open.fda.gov.

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References

  1. openFDA Drug Adverse Event API
  2. FDA: Questions and Answers on FAERS

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