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Pentosan polysulfate sodium Side Effects

For the Consumer

Applies to pentosan polysulfate sodium: oral capsule

Along with its needed effects, pentosan polysulfate sodium may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking pentosan polysulfate sodium:


Some side effects of pentosan polysulfate sodium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare

For Healthcare Professionals

Applies to pentosan polysulfate sodium: oral capsule


Gastrointestinal side effects have been reported the most frequently. These have included nausea, diarrhea, dyspepsia, vomiting, and rectal hemorrhage.[Ref]

In a phase 4 study of patients with interstitial cystitis (n=380) taking pentosan polysulfate sodium, the incidence of rectal hemorrhage was reported at 15% in patients taking doses of 900 mg/day versus 6.3% in patients taking the recommended daily dosage of 300 mg/day.[Ref]


Dermatologic side effects have included alopecia, pruritus, and urticaria.[Ref]

Nervous system

Nervous system side effects have included headache (3%) and dizziness (1%). Hyperkinesia, insomnia, and depression have also been reported.[Ref]


Hematologic side effects have included anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, and thrombocytopenia.[Ref]

There have been case reports of thrombocytopenia similar to heparin induced thrombocytopenia associated with a parenteral form of pentosan polysulfate sodium. It should be used with caution in patients with a history of heparin induced thrombocytopenia.[Ref]


Hepatic side effects have included liver function abnormalities: mildly elevated (<2.5 normal) transaminase, alkaline phosphatase, gamma-glutamyl transpeptidase, and lactic dehydrogenase.[Ref]


Respiratory side effects have included pharyngitis, rhinitis, epistaxis, and dyspnea.[Ref]


Ocular side effects have included conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage.[Ref]


Hypersensitivity side effects have included allergic reactions and photosensitivity.[Ref]


1. "Product Information. Elmiron (pentosan polysulfate sodium)." Baker Norton Pharmaceuticals, Miami, FL.

2. Wedren H "Effects of sodium pentosanpolysulphate on symptoms related to chronic non-bacterial prostatitis. A double-blind randomized study." Scand J Urol Nephrol 21 (1987): 81-8

3. Sie P, Albarede JL, Robert M, Bouloux C, Lansen J, Chigot C, Correll S, Thouvenot JP, Boneu B "Tolerance and biological activity of pentosan polysulfate after intramuscular or subcutaneous administration for ten days in human volunteers." Thromb Haemost 55 (1986): 86-9

4. Mulholland SG, Hanno P, Parsons CL, Sant GR, Staskin DR "Pentosan polysulfate sodium for therapy of interstitial cystitis. A double-blind placebo-controlled clinical study." Urology 35 (1990): 552-8

5. Tardy-Poncet B, Tardy B, Grelac F, Reynaud J, Mismetti P, Bertrand JC, Guyotat D "Pentosan polysulfate-induced thrombocytopenia and thrombosis." Am J Hematol 45 (1994): 252-7

6. Goad KE, Horne MK 3rd, Gralnick HR "Pentosan-induced thrombocytopenia: support for an immune complex mechanism." Br J Haematol 88 (1994): 803-8

Some side effects of pentosan polysulfate sodium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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