Pentosan polysulfate
ELMIRON
What it isSemisynthetic heparinoid restoring the bladder glycosaminoglycan layer; interstitial cystitis.
Why this oneIt is the only oral agent approved for interstitial cystitis.
What limits it⚑ Cumulative exposure can cause pigmentary maculopathy, so retinal screening is required. Benefit is modest and delayed.
FDA-approved for
- interstitial cystitis bladder pain (1996)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Interstitial cystitis pain | adult | 100 mg TID (300 mg/day) |
Renal Undefined
Hepatic Undefined
Instructions
- Take with water at least 1 h before or 2 h after meals
- Reassess at 3 months; if no improvement and no limiting adverse events, may continue another 3 months
- Value/risk of continued treatment beyond 6 months without improvement is unknown
Cautions
- Pigmentary maculopathy / retinal pigmentary changes with long-term use
- Increased bleeding risk (weak anticoagulant); caution with anticoagulants, NSAIDs, high-dose aspirin
- Liver function abnormalities
Adverse reactions
- Alopecia (4%)
- Diarrhea (4%), nausea (4%)
- Headache (3%)
- Rash (3%)
- Dyspepsia (2%), abdominal pain (2%)
- Rectal hemorrhage
- Dizziness (1%), liver function abnormalities (1%)
Pregnancy Animal studies show no fetal harm; use in pregnancy only if clearly needed.
Lactation Undefined
NO BOXED WARNINGS
Principal riskPigmentary maculopathy with cumulative exposure
Cost, est. cash$300–$2,500/month
Generic entryNo US generic
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Pentosan polysulfate ballicule
