Elmiron Uses and Side Effects

IC stands for interstitial cystitis, a chronic bladder condition with no known cure.

Elmiron (pentosan polysulfate sodium) is a prescription drug used to treat a disease called interstitial cystitis (IC). IC is a chronic, painful bladder condition. Elmiron may damage the eye (retina), potentially leading to blindness.

Elmiron users may be concerned about this side effect and how to respond to it. This page provides general information about Elmiron's uses, risks and alternatives. Consumers can use this page to better understand Elmiron and how it may affect them personally.

Note: Some physicians now urge Elmiron users to undergo vision screening for maculopathy (eye damage) at least once a year. Those with evidence of retinal damage or atrophy should discuss stopping Elmiron therapy with their doctor. Consumers should not alter their medication or dosage without first seeking professional medical advice.

Jump to the section below for information on Elmiron Alternatives >>>

What Is Elmiron (Pentosan Polysulfate Sodium) and What Does It Treat?

Elmiron is a sugar molecule (polysaccharide)-based drug. The U.S. Food and Drug Administration (FDA) approved Elmiron for the treatment of interstitial cystitis (IC). IC is a chronic, painful bladder condition with no known cause. Elmiron is the only pill the FDA has approved for the treatment of IC.

Jump to the Interstitial Cystitis Section >>>

Pentosan polysulfate sodium (PPS) is the active ingredient in Elmiron. It is a scentless white powder. PPS is a weak anticoagulant (blood thinner), but it is not used to treat clotting-related disorders.

General Elmiron Usage Information


Elmiron Usage Information PDF
Indication: for the relief of bladder pain/discomfort from interstitial cystitis (IC)
Dosage: 100 mg capsule, three times per day
Manufacturer: Ortho - McNeil - Janssen Pharmaceuticals, Inc.
Generic: none available
Typical Cost: ~$900 per 90-day supply


It may take three to six months for symptoms to improve
. The manufacturer has not determined the value or risk of taking the drug for more than six months in patients who do not achieve pain relief by that point.

Interesting Fact: PPS isn't just prescribed to humans. Veterinarians use an injectable form of PPS to treat osteoarthritis in animals.

Understanding Interstitial Cystitis and Elmiron

Interstitial cystitis (IC) is a rare but debilitating bladder condition. It affects approximately 1 million people in the United States. The disease mainly affects women.

IC causes a number of symptoms that can vary in frequency and severity.

Interstitial Cystitis Symptoms

  • Bladder, pelvic and/or abdominal pain
  • Frequent urination
  • Waking up in the night to urinate (nocturia)
  • Insomnia and fatigue (resulting from nocturia)
  • A feeling of urgency to urinate

What Causes Interstitial Cystitis?

Doctors and researchers have yet to determine a clear cause for IC. However, several theories have been proposed, one of which may explain Elmiron's efficacy in treating IC.

IC Cause Theory: Protective Coating Dysfunction
A healthy bladder creates a layer of protective molecules between urine and bladder tissue. These molecules have structures similar to PPS (Elmiron's active ingredient). Researchers believe this layer may be damaged or otherwise dysfunctional in IC patients. Without this protective layer intact, it may be possible for harmful substances to reach and irritate the bladder wall and muscle cells.

How Does Elmiron Help With Interstitial Cystitis?

How Elmiron works to treat IC is officially unknown. However, some publications have popularized one theory about its efficacy. Researchers claim PPS (Elmiron's active ingredient) may reinforce defective portions of the bladder's lining.

As per the theory above, PPS may supplement the bladder's natural lining. As the drug accumulates, PPS may fill in for bladder-lining molecules that are missing or damaged.

Interesting Fact: Scientific studies confirm that PPS does build up in the bladder over a period of months.

Once PPS reaches a certain level, the bladder lining may function better. This may explain how Elmiron reduces pain and other symptoms of IC.

Does Elmiron Cure Interstitial Cystitis?

No, Elmiron does not cure interstitial cystitis (IC). It does improve certain symptoms of IC. According to pre-approval clinical studies, approximately 38% of patients showed greater than 50% pain relief. This level of pain relief was only achieved after taking the drug for at least three months.

There is currently no known cure for IC, but research is ongoing.

Common Elmiron Side Effects

The most serious adverse event reported for Elmiron is eye damage. The specific form of eye damage Elmiron causes is called pigmentary maculopathy. This side effect is not referenced in the common side effects section of the drug label. However, you can find information about this side effect in the Warnings and Contraindications section below.

1 to 4% of Elmiron patients reported the following side effects in a pre-approval trial:

  • Hair loss (alopecia)
  • Diarrhea
  • Nausea
  • Headache
  • Rash
  • Indigestion
  • Stomach pain
  • Liver function changes
  • Dizziness

In a post-approval trial, 6.3% of patients reported rectal bleeding (hemorrhage). This occurred while taking the standard 100-mg dose of Elmiron three times a day. Another group of patients took 900 mg of the drug per day. In this higher dose group, 15% of patients reported rectal bleeding. 

Any patient who experiences a bleeding event while taking Elmiron should seek medical attention immediately. 

Warnings and Contraindications

The Elmiron drug label did not list any official warnings until very recently. In June 2020, Janssen Pharmaceuticals added a single warning for retinal pigmentary changes.

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of Elmiron

Prescribing InformationElmiron 100 mg Capsules

The label claims the visual consequences of these pigment abnormalities are unknown. Most cases of Elmiron vision loss occur after three or more years of use.

These pigmentary changes may come with the following symptoms:

  • Difficulty reading
  • Trouble adjusting to low light
  • Blurred vision

Elmiron users are instructed to have a baseline retinal examination before or shortly after starting the drug. The manufacturer also recommends regular follow-up screenings with a healthcare professional.

Elmiron Precautions

contraindication

a specific situation in which a drug should not be used, because it could harm the patient

Prescribers are urged to exercise caution when considering Elmiron for patients with:

  • Increased risk of bleeding for any reason
  • Previous heparin-related complications
  • Hepatic insufficiency

Patients should be aware that Elmiron does have a weak anti-clotting effect. This may prolong bleeding time.

Elmiron has only one contraindication. Elmiron should not be used in patients who have a known hypersensitivity to it or any similar drugs.

Notable Elmiron Drug Interactions

The manufacturer has investigated interactions between Elmiron and warfarin, a common anticoagulant. The level of warfarin in the human body was unchanged by the presence of Elmiron.

Prescribers should exercise caution when using Elmiron for IC patients who take other anticoagulants. Examples of other anticoagulants include heparin, warfarin, aspirin and Pradaxa.

Elmiron Alternatives

There are currently no other pill-based drugs approved to treat the same symptoms as Elmiron. Some patients have reported using over-the-counter drugs like Cystex and Azo, but they have not proven very effective.

Physicians have used other therapies in an off-label manner to treat IC, including:

  • Amitriptyline (an antidepressant)
  • Cyclosporine A (an immune system-modulating drug)
  • Adalimumab (an immune system-modulating drug)
  • Dimethyl sulfoxide (DMSO)
  • Capsaicin
  • Botox

Note: None of the therapies listed above are approved for treatment of IC. Some of them must be administered directly to the bladder. Patients should discuss potential Elmiron alternatives with a licensed physician.

Eye-Damage Lawsuits

A 2018 study found a link between Elmiron and a new form of macular disease. Some patients reported vision loss, such as difficulty reading and adapting to low-light situations.

A subsequent study found that symptoms did not improve after discontinuing the drug. Researchers believe this condition may involve permanent vision loss.

As a result, some Elmiron users have filed lawsuits against Elmiron manufacturers. These lawsuits claim manufacturers knew the drug could damage vision and did not warn patients.

Interesting Fact: Some physicians have mistaken Elmiron eye damage for age-related macular degeneration or pattern dystrophy.

Learn more about Elmiron lawsuits here.