ELMIRON: 23 Adverse Event Reports & Safety Profile
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23
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
23
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities
First Report: 2008 · Latest Report: 20140324
What Are the Most Common ELMIRON Side Effects?
#1 Most Reported
Incorrect dose administered
4 reports (17.4%)
#2 Most Reported
Headache
4 reports (17.4%)
#3 Most Reported
Fall
3 reports (13.0%)
All ELMIRON Side Effects by Frequency
No side effect data available.
Who Reports ELMIRON Side Effects? Age & Gender Data
Average age: 44.6 years. Most reports from: US. View detailed demographics →
Is ELMIRON Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 5 | 0 | 2 |
| 2013 | 5 | 0 | 3 |
| 2014 | 7 | 0 | 0 |
What Is ELMIRON Used For?
| Indication | Reports |
|---|---|
| Cystitis interstitial | 11 |
| Product used for unknown indication | 5 |
Official FDA Label for ELMIRON
Official prescribing information from the FDA-approved drug label.