FDA Notes Serious Side Effects Associated with Elmiron

Elmiron is currently the only FDA-approved medication for treating interstitial cystitis. The majority of those who use the drug are women, and the drug is most often used long-term for treating bladder pain and discomfort associated with interstitial cystitis. 

Elmiron has been prescribed for decades and may have adversely affected thousands of unsuspecting patients.  In 2019, three ophthalmologists conducted a review of patients at Kaiser Permanente in Northern California. They found that about one-quarter of patients with significant exposure to Elmiron showed definite signs of eye damage, and that this medication toxicity could masquerade as other known retinal conditions, such as age-related macular degeneration or pattern dystrophy.

The FDA has noted an increase in:

  • Maculopathy
  • Macular degeneration
  • Visual symptoms
  • Retinopathy

Pigmentary maculopathy has been reported with long-term use of Elmiron. These changes in the retina can cause vision loss or damage.

Most of these changes occurred after three years or longer of Elmiron use, according to the drug’s label. But some patients had eye damage after a shorter duration of use.

Other common side effects include:

  • Abnormal liver function tests
  • Blood in the stool
  • Bruising
  • Diarrhea
  • Dizziness
  • Hair loss
  • Headache
  • Nausea
  • Rash
  • Upset stomach

Plaintiffs in Elmiron lawsuits accuse Janssen Pharmaceuticals, the manufacturer of Elmiron, of failing to properly warn the public about the risk of vision problems.