Pentosan Polysulfate Sodium
Pronunciation: (PEN-toe-san POL-ee-SUL-fate).
- Generic name
- Pentosan polysulfate sodium
- Brand names
- Pentosan, Pentosan XR, Elmiron
- Drug class
- Urogenital & Renal System
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What Pentosan polysulfate sodium is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Pentosan polysulfate sodium works
Pentosan polysulfate is a semi-synthetic polysaccharide structurally similar to glycosaminoglycans. It is thought to adhere to the mucosal lining of the bladder, forming a protective barrier that prevents irritating solutes in the urine from reaching the bladder wall. This action reduces inflammation and pain associated with interstitial cystitis. (1)
What Pentosan polysulfate sodium is used for
Interstitial cystitis
Interstitial cystitis (3)
Bladder pain syndrome
Bladder pain syndrome (3)
Before taking Pentosan polysulfate sodium
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to pentosan polysulfate or excipients, and in those with active bleeding disorders. (Contraindication) (3)
Tell your clinician about
(3)How to take Pentosan polysulfate sodium
- General Instructions: Take pentosan polysulfate exactly as prescribed by your healthcare provider. It is usually taken by mouth, three times daily, at least 1 hour before or 2 hours after meals.. Adult Dosing: Typical adult dose is 100 mg orally three times daily.. Pediatric Dosing: Safety and efficacy in children have not been established; use in pediatric patients is not routinely recommended.. Administration: Swallow capsules whole with water. Do not crush or chew. Take on an empty stomach for best absorption.. When To Stop: Do not stop taking without consulting your healthcare provider. Discontinue if you develop serious side effects such as vision changes or severe bleeding.. Storage: Store at room temperature (20–25°C/68–77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (3)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take an extra dose to catch up.
Overdose
In case of overdose, seek emergency medical attention or call your local poison control center. Symptoms may include unusual bleeding, bruising, or severe stomach pain. Supportive care and monitoring are recommended. (3)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Alopecia
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Abdominal pain
Incidence: Reported in the clinician-authored database; frequency not established
Hemorrhage
Incidence: Reported in the clinician-authored database; frequency not established
Maculopathy
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
UPDATED (2026-08-07, FDA label) — serious
Symptoms: UPDATED (2026-08-07, FDA label): pigmentary maculopathy (retinal changes affecting the pigment layer of the eye) has been reported with long-term use of pentosan polysulfate — most cases occurred after 3 or more years of use, though some have been reported sooner. These retinal and vision changes may be irreversible and can continue to progress even after the medicine is stopped. The FDA label recommends a detailed eye (ophthalmologic) history before starting treatment, plus baseline and regular retinal examinations during treatment for early detection. Pentosan polysulfate is now contraindicated in patients with a personal history of any macular pathology (eye conditions affecting the macula) — tell your eye doctor and prescriber about any past retinal or macular problems before starting.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (3)
May increase risk of bleeding, especially if combined with anticoagulants or antiplatelet drugs — serious
Symptoms: May increase risk of bleeding, especially if combined with anticoagulants or antiplatelet drugs. Use with caution in patients with liver dysfunction. Not recommended during pregnancy unless clearly needed. Monitor for signs of hypersensitivity or allergic reaction.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (3)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to pentosan polysulfate or excipients, and in those with active bleeding disorders. Use with caution in patients with hepatic impairment, history of heparin-induced thrombocytopenia, or increased bleeding risk.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (3)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Pentosan polysulfate may interact with anticoagulants (e.g., warfarin, heparin), antiplatelet agents (e.g., aspirin, clopidogrel), and NSAIDs, increasing the risk of bleeding. Inform your healthcare provider about all medications and supplements you are taking. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Adequate, well-controlled studies of pentosan polysulfate have not been performed in pregnant women. Because animal studies do not always predict the human response, the FDA label states this drug should be used in pregnancy only if clearly needed — discuss the risks and benefits with the clinician managing your pregnancy. (3)
Breastfeeding
It is not known whether pentosan polysulfate passes into human breast milk. Because many drugs are excreted in breast milk, the FDA label advises caution when this medicine is given to a nursing woman; discuss feeding options with the clinician managing your or your baby's care. (3)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (3)
Renal_impairment
The FDA label states pentosan polysulfate's pharmacokinetics have not been studied in people with kidney or liver problems, so no specific dose adjustment exists for either. Because the liver contributes to clearing this medicine from the body, liver impairment may change how much of the drug stays in the body, and the label advises caution in that situation; the same caution reasonably applies to kidney impairment given the lack of dedicated study data. Tell the prescribing clinician about any kidney or liver disease. (3)
Hepatic_impairment
The FDA label states pentosan polysulfate's pharmacokinetics have not been studied in people with kidney or liver problems, so no specific dose adjustment exists for either. Because the liver contributes to clearing this medicine from the body, liver impairment may change how much of the drug stays in the body, and the label advises caution in that situation; the same caution reasonably applies to kidney impairment given the lack of dedicated study data. Tell the prescribing clinician about any kidney or liver disease. (3)
Monitoring
(3)Storage
Store at 20-25°C (68-77°F); excursions permitted between 15°C and 30°C (59-86°F). Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Interstitial cystitis
Dose summary: 100 mg orally three times a day.
Renal context: The FDA label states the pharmacokinetics of pentosan polysulfate sodium have not been studied in patients with renal or hepatic impairment, and no specific dose adjustment is given for either. Because there is evidence of a hepatic contribution to the drug's elimination, hepatic impairment may affect its pharmacokinetics, and the label advises caution when using it in that population; the same caution is reasonable to extend to renal impairment given the lack of dedicated study data. (1) (3)
Frequently asked questions
How long does it take for pentosan polysulfate to work?
Most patients begin to notice symptom improvement within 3 to 6 months of consistent use. Some may experience relief sooner, while others may require longer treatment.
Can pentosan polysulfate cure interstitial cystitis?
No, pentosan polysulfate does not cure interstitial cystitis but can significantly reduce bladder pain and discomfort.
Is pentosan polysulfate safe during pregnancy?
Pentosan polysulfate should only be used during pregnancy if clearly needed and prescribed by your doctor, as safety data are limited.
What should I do if I experience vision changes while taking pentosan polysulfate?
Contact your healthcare provider immediately if you notice any changes in your vision, such as difficulty reading or blurred vision. Long-term use has been associated with rare eye problems.
Can I take pentosan polysulfate with other pain medications?
You should consult your doctor before combining pentosan polysulfate with other pain medications, especially NSAIDs or blood thinners, due to increased bleeding risk.
Are there dietary restrictions while taking pentosan polysulfate?
There are no specific dietary restrictions, but take the medication on an empty stomach for best absorption.
What regular monitoring is required while on pentosan polysulfate?
Your doctor may recommend periodic blood tests, liver function tests, and eye exams to monitor for side effects, especially with long-term use.
What happens if I take too much Pentosan polysulfate?
Taking too much Pentosan polysulfate can increase the risk of side effects, particularly bleeding due to its mild anticoagulant properties. Symptoms may include easy bruising, nosebleeds, or blood in urine/stools. If you suspect an overdose, seek immediate emergency medical attention. Do not attempt to induce vomiting or self-treat.
Can I drink alcohol while taking Pentosan polysulfate?
While there are no direct contraindications, alcohol can irritate the bladder and exacerbate symptoms of interstitial cystitis, which Pentosan polysulfate aims to treat. Additionally, alcohol can increase the risk of gastrointestinal upset, a common side effect of Pentosan polysulfate. It is generally advisable to limit or avoid alcohol consumption while on this medication.
What is the mechanism of action of Pentosan polysulfate sodium?
Pentosan polysulfate is a semi-synthetic polysaccharide structurally similar to glycosaminoglycans. It is thought to adhere to the mucosal lining of the bladder, forming a protective barrier that prevents irritating solutes in the urine from reaching the bladder wall. This action reduces inflammation and pain associated with interstitial cystitis. (1)
What is the generic name of Pentosan Polysulfate Sodium?
The generic name is Pentosan polysulfate sodium. It is sold under brand names including Pentosan, Pentosan XR, Elmiron.
What class of drug is Pentosan polysulfate sodium?
Pentosan Polysulfate Sodium is classed as: Urogenital & Renal System.
References
- Pentosan Polysulfate for Bladder Pain Relief — Prescribing InformationDailyMed / U.S. National Library of Medicine · United States · accessed 2026-08-03 · source 1
- Clinician-authored medicine record for Pentosan polysulfate (MedGuideGlobal medicines database)MedGuideGlobal clinician-authored medicines database (internal) · International · dated 2026 · accessed 2026-08-07 · source 2
- ELMIRON (pentosan polysulfate sodium) capsules — full prescribing informationFDA DailyMed (Janssen Pharmaceuticals, Inc.) · United States · dated 2020 · accessed 2026-08-07 · source 3
- Pentosan Polysulfate — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- ELMIRON — FDA approval record (Drugs@FDA NDA020193)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- Pentosan polysulfate — RxNorm normalized drug concept (RXCUI 155046)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient Pentosan polysulfate sodium names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- ELMIRON100 mg · janssen pharmaceuticals, inc.
Canada
- ELMIRON