Medication Guide App

Elmiron Side Effects

Generic Name: pentosan polysulfate sodium

Note: This page contains information about the side effects of pentosan polysulfate sodium. Some of the dosage forms included on this document may not apply to the brand name Elmiron.

Not all side effects for Elmiron may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pentosan polysulfate sodium: oral capsule

Along with its needed effects, pentosan polysulfate sodium (the active ingredient contained in Elmiron) 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:

  • Chills
  • difficulty in breathing
  • fever
  • skin rash or hives
  • sore throat
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision impairment

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
  • Abdominal pain
  • bleeding gums
  • constipation
  • diarrhea
  • difficulty or pain upon swallowing
  • dizziness
  • dryness of throat
  • hair loss
  • headache
  • heartburn
  • increased sensitivity of skin to sunlight
  • irritated or red eyes
  • itching
  • loss of appetite
  • nausea
  • nosebleed
  • ringing in the ears
  • runny nose
  • sores in mouth
  • stomach gas
  • stomach upset
  • vomiting

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.

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.


Dermatologic side effects have included alopecia, pruritus, and urticaria.

Nervous system

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


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

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.


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


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


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


Hypersensitivity side effects have included allergic reactions and photosensitivity.

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