Prescription medicine
Pentosan polysulfate Brand names: Elmiron
Pentosan polysulfate (Elmiron) is a prescription medicine with an FDA approval on record since 1996. No generic is listed; pharmacies paid $12.10 per Elmiron 100 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the pentosan polysulfate FDA label on DailyMed (effective September 18, 2024, Janssen Pharmaceuticals, Inc.); the NDA 20193 record on Drugs@FDA; every pentosan polysulfate label on DailyMed.
Highlights of the record
FDA label of September 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Forms and strengths
- 100 mg
Gelatin-coated capsule.
On the market
- Earliest approval on file
- September 26, 1996 Elmiron, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $12.10 per capsule Elmiron 100 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2020 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 6,909 through July 30, 2026
What is pentosan polysulfate used for?
From the label: indications and usageELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
Conditions named in the indications of pentosan polysulfate's FDA labels, with every medicine labeled for each:
From other pentosan polysulfate labelsPain: INDICATIONS AND USAGE ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
FDA pharmacologic class: Glycosaminoglycan.
Source: FDA drug label (ELMIRON), Janssen Pharmaceuticals, Inc., effective September 18, 2024 (SPL set f0ba651e-3d8a-11df-8fbe-119855d89593), via openFDA; the full label on DailyMed
What does the patient leaflet for pentosan polysulfate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ELMIRON?Serious side effects have been reported with the use of ELMIRON, including: Changes in the retina of the eye (pigmentary maculopathy). Taking ELMIRON may be associated with pigment changes in the retina of the eye that may continue even after stopping treatment with ELMIRON. Tell your healthcare provider including your eye doctor right away if you have any vision changes including any of these symptoms: difficulty reading your vision takes longer to adjust to low or reduced light blurred vision Throughout your treatment, regular eye examinations that include retinal examinations are suggested for early detection of retinal/macular changes. Your doctor will discuss with you when to get your first eye examination and follow-up exams, and whether the treatment should be continued. Increased bleeding. ELMIRON may increase bleeding. Tell your healthcare provider right away if you have any of these symptoms: bruising easily nosebleeds bleeding gums blood in your stool Your risk of bleeding may be increased if you take ELMIRON along with other medicines such as: warfarin sodium heparin high doses of aspirin anti-inflammatory medicines such as ibuprofen Tell your healthcare provider if you are taking any of these medicines. Before you start taking ELMIRON, tell your healthcare provider if you are going to have surgery. Your healthcare provider may stop ELMIRON before you have surgery. Talk to your healthcare provider about when to stop taking ELMIRON and when to start taking it again.
From the patient leaflet: How should I store ELMIRON?Store ELMIRON at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Keep ELMIRON and all medicines out of the reach of children.
Source: FDA drug label (ELMIRON), Janssen Pharmaceuticals, Inc., effective September 18, 2024 (SPL set f0ba651e-3d8a-11df-8fbe-119855d89593), via openFDA; the full label on DailyMed
Is there a generic for pentosan polysulfate (Elmiron)?
No generic pentosan polysulfate is approved (Drugs@FDA, October 8, 2026).
- 1996 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pentosan polysulfate (Elmiron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12.10 per Elmiron 100 mg capsule, up 5% from $11.49 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Elmiron 100 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Elmiron 100 mg capsule | Brand | $12.10 per capsule | $362.89 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pentosan polysulfate been recalled?
The FDA's Enforcement Report lists 2 recalls naming pentosan polysulfate since 2020: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of pentosan polysulfate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 7, 2022 | Class II | TMC Acquisition LLC dba Tailor Made Compounding not a listed maker | Lack of Assurance of Sterility |
| November 30, 2020 | Class II | Advanced Nutriceuticals, LLC not a listed maker | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pentosan polysulfate label say about other medicines?
The pentosan polysulfate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drug-Drug Interactions In a study in which healthy subjects received pentosan polysulfate sodium 100 mg capsule or placebo every 8 hours for 7 days, and were titrated with warfarin to an INR of 1.4 to 1.8, the pharmacokinetic parameters of R-warfarin and S-warfarin were similar in the absence and presence of pentosan … |
Source: FDA drug label (ELMIRON), Janssen Pharmaceuticals, Inc., effective September 18, 2024 (SPL set f0ba651e-3d8a-11df-8fbe-119855d89593), via openFDA; the full label on DailyMed
What do FAERS reports show for pentosan polysulfate?
The FDA Adverse Event Reporting System holds 6,909 reports that list pentosan polysulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 117 are coded as a death and 650 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2022 (1,540, against a median of 334 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pentosan polysulfate?
34 other medicines are given the same way (oral) and in the same FDA class as pentosan polysulfate or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Aspirin | Pain | none listed | $0.0142 per tablet 81 mg tablet | A presentation being discontinued |
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Diclofenac | Pain | 67 labelers | $0.0619 per tablet 75 mg tablet | A presentation being discontinued |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Phenazopyridine | Pain | none listed | $0.154 per tablet 100 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Pentosan polysulfate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other