Miscellaneous urogenital disorders:

Indications for: ELMIRON

Bladder pain/discomfort due to interstitial cystitis.

Clinical Trials:

Two clinical trials evaluated the efficacy and safety of Elmiron for the relief of pain in patients with chronic interstitial cystitis (IC).

  • Trial 1: The blinded, randomized, placebo-controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years. Patients were randomly assigned 1:1 to receive either placebo or Elmiron 100 mg three times a day for 3 months. 

    • 38% of patients treated with Elmiron showed greater than 50% improvement in bladder pain vs 18% of patients treated with placebo (P =.005).

  • Trial 2: The second clinical trial was a prospectively designed retrospective analysis of 2499 patients (2220 women, 254 men, 25 unknown) with a mean age of 47 years who received Elmiron 300 mg/day without blinding.

    • At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by 1 or 2 categories. 

    • By 6 months, in the 892 patients who continued taking Elmiron, an additional 116/2499 (5%) of patients had improved pain scores. 

    • After 6 months, the percent of patients who reported the first onset of pain relief was less than 1.5% of patients who originally entered in the study.

Adult Dosage:

Take with water 1 hr before or 2 hrs after meals. ≥16yrs: 100mg 3 times daily. Reevaluate at 3 and 6 months.

Children Dosage:

<16yrs: not established.

ELMIRON Warnings/Precautions:

Retinal pigmentary changes. Do retinal exam (including OCT, auto-fluorescence imaging) at baseline, within 6 months of initiation, periodically during and after treatment completion. Bleeding or risk of bleeding (eg, surgery, aneurysm, hemophilia, GI ulcers, polyps, diverticula). History of heparin-induced thrombocytopenia. Hepatic insufficiency. Pregnancy. Nursing mothers.

ELMIRON Classification:

Bladder protectant.

ELMIRON Interactions:

Caution with drugs that increase bleeding risk (eg, anticoagulants, tPA, aspirin, NSAIDs).

Adverse Reactions:

Alopecia, diarrhea, nausea, headache, rash, dyspepsia, abdominal pain, liver function abnormalities, dizziness, increased prothrombin time, hemorrhage.


  • Metabolized by partial desulfation in the liver and spleen, and by partial depolymerization in the kidney to a large number of metabolites. 

  • Both the desulfation and depolymerization can be saturated with continued dosing. 

Drug Elimination:

  • Fecal (mean 84% in the 300 mg group; mean 58% in the 450 mg group), renal (mean 6%).

  • Mean half-life: 27 hours (for 300 mg dose); 20 hours (for 450 mg dose).

Generic Drug Availability:


How Supplied: