Drug · FAERS side-effect profile with label screen
Pentosan Polysulfate side effects: what 6,908 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pentosan Polysulfate Sodium (Elmiron)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,908 reports · 70% serious · 117 with death outcome · 91% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.
FDA label, Indications and Usage
What it is
DESCRIPTION Pentosan polysulfate sodium is a semi-synthetically produced heparin-like macromolecular carbohydrate derivative, which chemically and structurally resembles glycosaminoglycans. It is a white odorless powder, slightly hygroscopic and soluble in water to 50% at pH 6.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Likely indication confounding 2Reporting / coding artifact 7Lab value / disease marker 1Not in label — unassessed 28
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 203 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Macular degeneration | 214 | 55.5 48.6–63.4ROR 57.2 · χ² 11,195 / p <1e-300 | 54.2 EB05 48.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 | no trial data cached |
| Bladder disorder | 44 | 13.5 10.0–18.1ROR 13.6 · χ² 494 / p 1e-109 | 13.2 EB05 10.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious n=26 · 83% consumer | no trial data cached |
| Appendicitis | 27 | 8.8 6.1–12.9ROR 8.9 · χ² 179 / p 3e-41 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 12% (drug 91%) · 96% clinician | no trial data cached |
| Coeliac disease | 26 | 8.1 5.5–11.8ROR 8.1 · χ² 153 / p 2e-35 | 7.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 76% consumer | no trial data cached |
| Vitreous floaters | 25 | 7.8 5.3–11.6ROR 7.8 · χ² 141 / p 7e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Drug prescribing error | 45 | 7.0 5.2–9.4ROR 7.1 · χ² 226 / p 2e-51 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=14 · 87% consumer | no trial data cached |
| Blindness | 86 | 6.4 5.2–7.9ROR 6.5 · χ² 388 / p 1e-86 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Ventricular fibrillation | 23 | 6.3 4.2–9.4ROR 6.3 · χ² 97 / p 4e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 0% (drug 91%) · 100% clinician | no trial data cached |
| Micturition urgency | 23 | 6.2 4.1–9.3ROR 6.2 · χ² 94 / p 1e-22 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Ulcer | 32 | 6.1 4.3–8.6ROR 6.1 · χ² 131 / p 1e-30 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · ♀ 39% (drug 91%) | no trial data cached |
| Retinal detachment | 17 | 5.6 3.5–9.0ROR 5.6 · χ² 60 / p 5e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Cystitis | 59 | 5.6 4.4–7.2ROR 5.7 · χ² 219 / p 8e-50 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.3 · 76% consumer | no trial data cached |
| Hyperlipidaemia | 22 | 5.6 3.7–8.5ROR 5.6 · χ² 78 / p 5e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 24% (drug 91%) · 90% clinician | no trial data cached |
| Intervertebral disc degeneration | 16 | 5.2 3.2–8.5ROR 5.2 · χ² 50 / p 6e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Off label use (used outside approved label) | 1,401 | 4.9 4.7–5.1ROR 5.9 · χ² 4,534 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Cardiogenic shock | 23 | 4.9 3.3–7.4ROR 4.9 · χ² 67 / p 1e-16 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 0% (drug 91%) · 100% clinician | no trial data cached |
| Product use issue | 272 | 4.4 3.9–5.0ROR 4.6 · χ² 722 / p 3e-159 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Incorrect route of product administration | 23 | 4.2 2.8–6.3ROR 4.2 · χ² 52 / p 3e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 91% clinician | no trial data cached |
| Blood urine present | 26 | 4.1 2.8–6.1ROR 4.2 · χ² 59 / p 8e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 · 88% consumer | no trial data cached |
| Neuralgia | 33 | 4.1 2.9–5.8ROR 4.1 · χ² 75 / p 2e-18 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 41% (drug 91%) | no trial data cached |
| Irritable bowel syndrome | 29 | 4.1 2.9–5.9ROR 4.1 · χ² 65 / p 3e-16 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Blood test abnormal | 19 | 4.1 2.6–6.4ROR 4.1 · χ² 42 / p 5e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Bacterial infection | 25 | 4.1 2.8–6.0ROR 4.1 · χ² 55 / p 5e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 22% (drug 91%) | no trial data cached |
| Tenderness | 14 | 4.1 2.4–6.9ROR 4.1 · χ² 29 / p 3e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pelvic pain | 24 | 4.0 2.7–6.0ROR 4.0 · χ² 51 / p 4e-13 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Dry eye | 63 | 4.0 3.1–5.1ROR 4.0 · χ² 136 / p 1e-31 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Dysuria (painful urination) | 47 | 3.9 2.9–5.2ROR 3.9 · χ² 97 / p 3e-23 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 74% consumer | no trial data cached |
| Fibromyalgia | 30 | 3.8 2.6–5.4ROR 3.8 · χ² 58 / p 1e-14 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Visual impairment | 151 | 3.7 3.2–4.4ROR 3.8 · χ² 300 / p 2e-67 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 79% consumer | no trial data cached |
| End stage renal disease | 21 | 3.5 2.3–5.3ROR 3.5 · χ² 34 / p 2e-9 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Gout | 20 | 3.4 2.2–5.2ROR 3.4 · χ² 31 / p 1e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Pollakiuria (frequent urination) | 46 | 3.4 2.5–4.5ROR 3.4 · χ² 74 / p 4e-18 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 77% consumer | no trial data cached |
| Increased tendency to bruise | 10 | 3.3 1.8–6.1ROR 3.3 · χ² 14 / p 1e-4 | 2.9 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious n=8 | no trial data cached |
| Alopecia (hair loss) | 206 | 3.2 2.8–3.6ROR 3.2 · χ² 308 / p 3e-69 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 87% consumer | no trial data cached |
| Eye disorder | 34 | 3.2 2.3–4.4ROR 3.2 · χ² 48 / p 2e-12 | 3.0 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Vitamin d deficiency | 10 | 3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Inappropriate schedule of drug administration | 73 | 3.1 2.4–3.9ROR 3.1 · χ² 100 / p 7e-24 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 90% consumer | no trial data cached |
| Dry throat | 10 | 3.0 1.6–5.6ROR 3.0 · χ² 11 / p 4e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | – | no trial data cached |
| Wrong technique in drug usage process | 36 | 3.0 2.1–4.1ROR 3.0 · χ² 45 / p 1e-11 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 81% consumer | no trial data cached |
| Tendonitis | 15 | 2.9 1.8–4.9ROR 2.9 · χ² 17 / p 2e-5 | 2.7 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 1,401 | 4.9 4.7–5.1ROR 5.9 · χ² 4,534 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Pain | 305 | 1.5 1.3–1.7ROR 1.5 · χ² 53 / p 2e-13 | 1.5 EB05 1.4 · IC025 +0.4 | Likely indication confounding term in indications; also in warnings | serious PRR 1.0 | no trial data cached |
| Product use issue | 272 | 4.4 3.9–5.0ROR 4.6 · χ² 722 / p 3e-159 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Macular degeneration | 214 | 55.5 48.6–63.4ROR 57.2 · χ² 11,195 / p <1e-300 | 54.2 EB05 48.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 48.2 | no trial data cached |
| Alopecia (hair loss) | 206 | 3.2 2.8–3.6ROR 3.2 · χ² 308 / p 3e-69 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 87% consumer | no trial data cached |
| Depression | 178 | 2.4 2.0–2.7ROR 2.4 · χ² 140 / p 1e-32 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Anxiety | 175 | 1.9 1.6–2.2ROR 1.9 · χ² 70 / p 3e-17 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Incorrect dose administered | 158 | 2.1 1.8–2.5ROR 2.2 · χ² 95 / p 1e-22 | 2.1 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 4.2 · 80% consumer | no trial data cached |
| Visual impairment | 151 | 3.7 3.2–4.4ROR 3.8 · χ² 300 / p 2e-67 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 79% consumer | no trial data cached |
| Toxicity to various agents | 148 | 2.7 2.3–3.1ROR 2.7 · χ² 155 / p 7e-36 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Vision blurred (blurred vision) | 121 | 2.7 2.3–3.2ROR 2.7 · χ² 127 / p 7e-30 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 | no trial data cached |
| Urinary tract infection (bladder infection) | 119 | 2.1 1.8–2.5ROR 2.1 · χ² 70 / p 3e-17 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.4 · 70% consumer | no trial data cached |
| Drug dose omission | 115 | 2.1 1.7–2.5ROR 2.1 · χ² 64 / p 6e-16 | 2.1 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.8 · 83% consumer | no trial data cached |
| Inappropriate schedule of product administration | 88 | 1.5 1.2–1.9ROR 1.5 · χ² 15 / p 6e-5 | 1.5 EB05 1.3 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Blindness | 86 | 6.4 5.2–7.9ROR 6.5 · χ² 388 / p 1e-86 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Macular degeneration — n=214, PRR 55.5
- Appendicitis — n=27, PRR 8.8
- Coeliac disease — n=26, PRR 8.1
- Vitreous floaters — n=25, PRR 7.8
- Blindness — n=86, PRR 6.4
- Ventricular fibrillation — n=23, PRR 6.3
- Micturition urgency — n=23, PRR 6.2
- Hyperlipidaemia — n=22, PRR 5.6
- Cardiogenic shock — n=23, PRR 4.9
- Neuralgia — n=33, PRR 4.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pentosan Polysulfate?
In FDA FAERS, the most frequently co-reported reaction terms for Pentosan Polysulfate are pain, macular degeneration, alopecia, depression, anxiety, visual impairment. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pentosan Polysulfate have an FDA boxed warning?
No. The FDA label retrieved for Pentosan Polysulfate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pentosan Polysulfate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f0ba651e-3d8a-11df-8fbe-119855d89593, effective 20240918; matched on
openfda.generic_name.exact:"PENTOSAN POLYSULFATE SODIUM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 243 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.