Pentosan Polysulfate: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 1, 2026🚩 Report this page

Pentosan Polysulfate

Active ingredient

GB MHRA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Pentosan Polysulfate is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	May 1, 2026

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 1, 2026[1]

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How to take

GBOfficial regulatory label· revised May 1, 2026

Drug interactions

Known interactions involving Pentosan Polysulfate. Select one for details. This list is informational and not a complete interaction checker.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB124040001 · revised May 1, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 1, 2026[1]

Summary of the safety profile The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium. The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
The most common adverse events reported from the clinical studies are headache, dizziness and gastro-intestinal events like diarrhoea, nausea, abdominal pain and rectal bleeding. The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity.
Tabulated summary of adverse events Adverse events are listed below by MedDRA body system organ class and by frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Infections and infestations Common Infections, influenza Uncommon Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopeniaBlood and lymphatic system disorders Not known Coagulation disorders Uncommon Photosensitivity Immune system disorder Not known Allergic reactions Metabolism and nutrition disorders Uncommon Anorexia, weight gain, weight loss Psychiatric disorders Uncommon Severe Emotional Lability/Depression Common Headache, dizziness Nervous system disorders Uncommon Increased sweating, insomnia, hyperkinesia, paraesthesia Eye disorders Uncommon Lacrimation, amblyopia Ear disorders Uncommon Tinnitus Respiratory, thoracic and mediastinal disorders Uncommon Dyspnoea Common Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhageGastrointestinal disorders Uncommon Indigestion, vomiting, mouth ulcer, flatulence, constipation Common Peripheral oedema, alopeciaSkin and subcutaneous tissue disorders Uncommon Rash, increased mole size Common Back painMusculoskeletal and connective tissue disorders Uncommon Myalgia, Arthralgia Renal and urinary disorders Common Urinary frequency General disorders and administration site conditions Common Asthenia, pelvic pain Investigation Not known Liver function abnormalities Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised May 1, 2026[1]

Bladder pain syndrome is a diagnosis of exclusion and other urologic disorders should be eliminated by the prescriber, such as urinary tract infection or bladder cancer. Pentosan polysulfate sodium is a weak anticoagulant. 5)) should be evaluated for haemorrhagic events.
Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium. Hepatic or renal insufficiency pentosan polysulfate sodium capsules have not been studied in patients with hepatic or renal insufficiency.
Because there is evidence of hepatic and renal contribution to the elimination of pentosan polysulfate sodium, hepatic or renal impairment may have an impact on the pharmacokinetics of pentosan polysulfate sodium. Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium.
Rare cases of pigmentary maculopathy have been reported with use of pentosan polysulfate sodium (PPS), especially after long term use. Visual symptoms might include complaints of difficulty when reading, visual distortions, altered colour vision and/or slow adjustment to low or reduced light environments.
All patients should have an ophthalmologic examination after 6 months of use of PPS for early detection of pigmentary maculopathy, and, if there are no pathologic findings, regularly after 5 years of use (or earlier, in case of visual complaints).
However, in case of relevant ophthalmologic findings, a yearly examination should be conducted. In such situations, treatment cessation should be considered. This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.