Skip to Content

Elmiron Side Effects

Generic Name: pentosan polysulfate sodium

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

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:

Rare

  • 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

For Healthcare Professionals

Applies to pentosan polysulfate sodium: oral capsule

General

The most frequently reported side effects were alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, and dizziness.[Ref]

Dermatologic

Common (1% to 10%): Alopecia, rash

Frequency not reported: Ecchymosis, photosensitivity, pruritus, urticaria, sweating increased[Ref]

Hepatic

Common (1% to 10%): Liver function abnormal

Frequency not reported: Liver function test elevated[Ref]

Genitourinary

Common (1% to 10%): Urinary frequency

Frequency not reported: Vaginitis, pelvic pain[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dyspepsia, abdominal pain

Frequency not reported: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, gum hemorrhage, enlarged abdomen

Postmarketing reports: Rectal hemorrhage[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Frequency not reported: Hyperkinesia[Ref]

Hematologic

Frequency not reported: Anemia, prothrombin time increased, partial thromboplastin time increased, leukopenia, thrombocytopenia, coagulation disorder[Ref]

Respiratory

Frequency not reported: Pharyngitis, rhinitis, epistaxis, dyspnea[Ref]

Ocular

Frequency not reported: Conjunctivitis, optic neuritis, amblyopia, retinal hemorrhage, lacrimation, nystagmus[Ref]

Immunologic

Frequency not reported: Allergic reaction[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia[Ref]

Psychiatric

Frequency not reported: Emotional lability/depression, insomnia, mood swings, suicidal ideation[Ref]

Other

Uncommon (0.1% to 1%): Weight gain, weight loss

Frequency not reported: Tinnitus, peripheral edema, asthenia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Myalgia, arthralgia[Ref]

References

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

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide