Pentosan Polysulfate: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Pentosan Polysulfate. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| 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 across placebo-controlled trial tables summarized in current labeling.
Labeled uses
ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Source: FDA labeling via NIH DailyMed (set f0ba651e…). Not affiliated with FDA or NIH.
Medical disclaimer: Always consult a qualified healthcare professional about any medication.