Elmiron, also known as pentosan polysulfate sodium, is a prescription drug approved to treat pain and discomfort caused by interstitial cystitis. It’s also a weak blood thinner. Common side effects include hair loss, diarrhea and nausea. Rare but serious side effects include bleeding and vision problems.

Consumernotice.org adheres to the highest ethical standards for content production and distribution. All content is thoroughly researched and verified at each stage of the publication process.

Our writers and editors follow strict guidelines for written and visual content, including vetting all sources and verifying quotes and statistics, to guarantee honesty and integrity in our reporting.

We collaborate with legal and medical experts and consumer safety professionals to further ensure the accuracy of our content.

The U.S. Food and Drug Administration approved Elmiron in 1996. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, manufactures the drug.

There’s currently no generic version of the medication, and it’s the only oral drug approved to treat bladder pain and discomfort associated with interstitial cystitis (IC). IC is a chronic bladder condition that affects between 3 and 8 million women and 1 to 4 million men, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Elmiron is recommended as a second-option therapy after nondrug-based interventions such as patient education and lifestyle changes.

Most people who use Elmiron are women. It’s estimated that hundreds of thousands of people have used the drug, according to Drs. Adam M. Hanif and Nieraj Jain in their July 2019 study published in Review of Ophthalmology.

Elmiron treats discomfort and pain caused by IC, but it’s not a pain medication. It also has mild anticoagulant effects but it’s not indicated for use as a blood thinner such as warfarin or other anticoagulants. Elmiron isn’t a cure for IC.

In one blinded, randomized, placebo-controlled study, 28 out of 74 patients who received Elmiron reported 50% improvement in bladder pain after three months.

This medication’s active ingredient is called pentosan polysulfate sodium. Inactive ingredients in each white, opaque, hard gelatin capsule include pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10 aluminum lake, n-butyl alcohol, propylene glycol, SDA-3A alcohol and titanium dioxide.

Janssen doesn’t know how Elmiron works to treat IC. Scientists think it works by sticking to the bladder wall membrane. The drug acts like a shield, making it more difficult for irritants from urine to reach bladder wall cells.

The recommended dose of Elmiron is one 100 mg capsule three times a day by mouth for a total of 300 mg. Take this medication with water when your stomach is empty at least one hour before meals or two hours after meals.

After three months, people taking Elmiron should visit their medical providers to see if there is improvement in symptoms. If there is no improvement, patients may continue taking the drug for another three months. Treatment beyond six months hasn’t been evaluated for safety or effectiveness in clinical trials.

Researchers studied Elmiron’s safety in an unblinded clinical trial of 2,499 IC patients. The most common side effects occurred in 1% to 4% of people.

Elmiron is a weak anticoagulant about 1/15th the strength of heparin. In a study of 128 people who took 300 mg of Elmiron each day, about eight patients (6.3%) suffered rectal hemorrhage. Other bleeding complications have been reported.

Other side effects that occurred in 1% or less than 1% of participants include vomiting, flatulence, constipation, anemia, allergic reactions, photosensitivity, cold-like symptoms, itchy skin, conjunctivitis, tinnitus and retinal hemorrhage.

In June 2020, Janssen added a warning for retinal pigmentary changes to the drug’s label. Long-term use of Elmiron may lead to pigmentary maculopathy, an eye disorder that damages the retina. Symptoms include difficulty reading, blurred vision or trouble adjusting to low light environments.

Damage to the retina may be irreversible and the damage may continue to progress even after stopping treatment with Elmiron.

Elmiron hasn’t been studied in patients younger than 16 years of age.

Though animal studies using an IV formulation didn’t find that the drug affected the fetus or impaired fertility, the prescribing information cautions that pregnant women shouldn’t use the drug unless it’s clearly needed. Researchers don’t know if the drug is excreted in breast milk and nursing mothers should use caution.

There have been no recalls of Elmiron. Recently, studies from 2018 to 2020 have surfaced linking the drug to potentially permanent vision problems. Eye doctors have linked long-term use of the drug to a unique type of maculopathy called pigmentary maculopathy.

Janssen added a warning for retinal pigmentary changes in June 2020, but the FDA has not released a safety communication or recommended a recall so far.

Patients who suffered vision damage after taking Elmiron have filed lawsuits against Janssen Pharmaceuticals. Elmiron lawsuits say the drugmaker knew the drug could cause vision problems but failed to warn patients and doctors.

In September 2020, there were about 50 cases across the country, with about half in the Eastern District of Pennsylvania, according to lawyers. They expect that number to grow to 1,000 or more.

Consumernotice.org adheres to the highest ethical standards for content production and references only credible sources of information, including government reports, interviews with experts, highly regarded nonprofit organizations, peer-reviewed journals, court records and academic organizations. You can learn more about our dedication to relevance, accuracy and transparency by reading our editorial policy.

Consumernotice.org adheres to the highest ethical standards for content production and distribution. All content is thoroughly researched and verified at each stage of the publication process.

Our writers and editors follow strict guidelines for written and visual content, including vetting all sources and verifying quotes and statistics, to guarantee honesty and integrity in our reporting.

We collaborate with legal and medical experts and consumer safety professionals to further ensure the accuracy of our content.

We'd love to hear your thoughts. Were you able to find the information you were looking for on ConsumerNotice.org?

Thank you for your feedback.

Do you have any thoughts you'd like to share about ConsumerNotice.org?

How can we improve this page?

How can we improve this page?

Thank You for Your Feedback

We appreciate your feedback. One of our content team members will be in touch with you soon.

We appreciate your feedback. One of our content team members will be in touch with you soon.

Protecting you and your loved ones from harmful products and poorly regulated industries through awareness, education and shared experiences.

1 South Orange Ave., Suite 203, Orlando, FL 32801

Your web browser is no longer supported by Microsoft. Update your browser for more security, speed and compatibility.

Calling this number connects you with a Consumernotice.org representative. We will connect you with one of our trusted legal partners for a free case review.

Consumernotice.org’s sponsors support the organization’s mission to provide reliable health and safety information and empower consumers to assert their legal rights. For more information, visit our About page.