Elmiron

Elmiron (pentosan polysulfate sodium) is an oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of interstitial cystitis (IC), a chronic condition causing bladder pain and discomfort.

IC is sometimes called bladder pain syndrome. Elmiron is the only FDA-approved oral treatment for IC, a disease that affects up to 12 million people in the U.S. More women than men have IC, which predominantly affects adults

Due to the persistent nature of IC, doctors may prescribe Elmiron for long-term use. Research published in the journal Ophthalmology found that roughly 1 in 4 people taking Elmiron for five years or longer developed significant retina damage. The retina is a thin layer at the back of the eye that senses light. It sends signals to the brain through the optic nerve, helping us see images.

Concerns over vision damage led the FDA to add a black box warning (the agency’s most serious alert) to Elmiron’s label. These issues have also resulted in nearly 2,000 Elmiron lawsuits claiming vision injury, including over 900 pending lawsuits.

Common Elmiron Side Effects

While most people take Elmiron without any problems, some may experience side effects when taking the medication.

In addition, Elmiron may increase bleeding risks. You should let your doctor know right away if you suddenly start experiencing nose bleeds or bleeding gums, bruising easily or discover blood in your stool.

The most concerning Elmiron side effects are linked to long-term use. Scientific research associates Elmiron with an eye disease called pigmentary maculopathy, which can lead to severe vision loss.

Research has linked Elmiron use to pigmentary maculopathy. This condition is also known as PPS maculopathy, named after the active ingredient in Elmiron — pentosan polysulfate sodium. Avoiding Elmiron treatment is the only known way to prevent this condition.

Pigmentary maculopathy gradually affects a part of the retina called the macula, which helps people clearly see objects directly in front of them. As the disease progresses, it can lead to serious vision problems.

The likelihood of developing pigmentary maculopathy increases based on how much Elmiron a patient takes over time. Researchers found that the risk for eye issues jumps from about 12.7% for those who took between 500 and 999 grams to as high as 41.7% for those who took over 1,500 grams. On average, people taking Elmiron receive around 100 grams each year, meaning they could potentially start to experience eye damage within three to five years.

The symptoms of Elmiron are similar to macular degeneration, a common age-related condition, which can delay proper diagnosis and treatment. It’s important to see an ophthalmologist if you experience vision problems while taking Elmiron.

In June 2020, the FDA approved changes to Elmiron’s label, adding a black box warning for pigmentary maculopathy following multiple reports of severe eye problems, including potential permanent vision loss. The FDA also recommended periodic eye exams for people taking Elmiron.

Reports related to maculopathy and macular degeneration account for more than 60% of all Elmiron adverse events reported to the FDA.

Despite these warnings and a high rate of vision-related adverse event reports, Elmiron is still available in the United States as of August 2025. Elmiron’s manufacturer — Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson — has not issued any Elmiron recalls or pulled the drug from the market.

People began filing Elmiron lawsuits following research linking the drug to vision problems and the FDA’s addition of vision-related side effects to Elmiron’s label.

A federal panel combined 128 Elmiron lawsuits into a multidistrict litigation (MDL) in December 2020. An MDL allows for the consolidation of multiple similar lawsuits into a single litigation to expedite the legal process. To date, the U.S. Judicial Panel on Multidistrict Litigation has consolidated almost 2,000 lawsuits into the MDL. As of August 2025, there were 795 cases still pending.

The number of cases pending has been slowly decreasing, suggesting that Jannsen has been settling cases confidentially. Drugwatch’s legal partners are no longer accepting Elmiron cases.

What Do Elmiron Lawsuits Claim?

Elmiron lawsuits claim that the medication caused injuries to people’s retinas, particularly maculopathy.

A study of the lawsuits in the MDL, published in The Journal of Urology, examined cases from 2018 to 2023 involving people who suffered vision problems after using Elmiron. On average, these users took the medication for 13.4 years, with plaintiffs using it for between two and 25 years.

The most common injury claimed in lawsuits reviewed for the study was macular damage, accounting for 28% of the claims.

If you believe Elmiron has caused you harm, it’s crucial to prioritize your health and eyesight. Contact your doctor right away if you notice any changes in your vision, like blurriness, difficulty reading, trouble seeing in the dark, spots in your vision or distorted eyesight.

It’s a good idea to get a complete check-up with an eye doctor, especially if you’ve been using Elmiron for several months or more, as eye damage can be severe. Elmiron may also increase the risk of bleeding from surgery or dental work involving extractions or gum surgery. Always tell your doctor, dentist or other health care provider that you are taking Elmiron before undergoing surgery or dental procedures. Also, let them know about any new bruising or bleeding issues you may experience.

Keep a record of any symptoms you experience and the medications you take. Before stopping Elmiron, have a conversation with your doctor about alternative treatments. If you’re already facing problems or your vision loss is impacting your daily life, reach out to a lawyer for advice. Drugwatch is unaware of any attorneys currently accepting Elmiron lawsuits, but discussing your case with an attorney may protect your future rights.