Pentosan Polysulfate: Side Effects, Uses & Monitoring
ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
- Data source
- FDA labeling via NIH DailyMed (label f0ba651e…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Total events | 27% |
| Gi overall number of patients | 7% |
| Diarrhea | 6% |
| Skin/allergic overall number of patients | 4% |
| Headache | 3% |
| Nausea | 3% |
| Other overall number of patients | 3% |
| Severe emotional lability/depression | 2% |
| Vomiting | 2% |
| Rash | 2% |
| Pruritus | 2% |
| Insomnia | 1% |
| Nystagmus/dizziness | 1% |
| Hyperkinesia | 1% |
| Dyspepsia | 1% |
| Jaundice | 1% |
| Lacrimation | 1% |
| Rhinitis | 1% |
| Increased sweating | 1% |
| Amenorrhea | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Conditions associated with Pentosan Polysulfate in labeling
Frequently Asked Questions
What is Pentosan Polysulfate used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Pentosan Polysulfate?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Pentosan Polysulfate. Individual risk varies.
Does Pentosan Polysulfate require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Pentosan Polysulfate.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.