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.

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

For the Consumer

Applies to pentosan polysulfate sodium: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking pentosan polysulfate sodium (the active ingredient contained in Elmiron) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• nosebleed;

• blood in your urine or stools;

• rectal bleeding;

• coughing up blood;

• bleeding gums; or

• feeling like you might pass out.

Less serious side effects of pentosan polysulfate sodium may include:

• hair loss;

• nausea, diarrhea, stomach pain;

• headache;

• mild dizziness;

• depressed mood; or

• mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pentosan polysulfate sodium: oral capsule

Gastrointestinal

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

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

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

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

Respiratory

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

Ocular

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

Hypersensitivity

Hypersensitivity side effects have included allergic reactions and photosensitivity.

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