ELMIRON® was evaluated in clinical trials in a total of 2627 patients (2343 women, 262 men, 22 unknown) with a mean age of 47 [range 18 to 88 with 581 (22%) over 60 years of age]. Of the 2627 patients, 128 patients were in a 3-month trial and the remaining 2499 patients were in a long-term, unblinded trial.
Deaths occurred in 6/2627 (0.2%) patients who received the drug over a period of 3 to 75 months. The deaths appear to be related to other concurrent illnesses or procedures, except in one patient for whom the cause was not known.
Serious adverse events occurred in 33/2627 (1.3%) patients. Two patients had severe abdominal pain or diarrhea and dehydration that required hospitalization. Because there was not a control group of patients with interstitial cystitis who were concurrently evaluated, it is difficult to determine which events are associated with ELMIRON® and which events are associated with concurrent illness, medicine, or other factors.
Adverse Experience in Placebo-Controlled Clinical
Trials of ELMIRON® 100 mg Three Times a Day for 3 Months
|Body System/Adverse Experience||ELMIRON®
|CNS Overall Number of Patients*||3||5|
|Severe Emotional Lability/Depression||2||1|
|GI Overall Number of Patients*||7||7|
|Skin/Allergic Overall Number of Patients*||2||4|
|Other Overall Number of Patients*||1||3|
|Total Number of Patients Reporting Adverse Events||13||19|
|* Within a body system, the individual events do not sum to equal overall number of patients because a patient may have more than one event.|
The adverse events described below were reported in an unblinded clinical trial of 2499 interstitial cystitis patients treated with ELMIRON®. Of the original 2499 patients, 1192 (48%) received ELMIRON® for 3 months; 892 (36%) received ELMIRON for 6 months; and 598 (24%) received ELMIRON® for one year, 355 (14%) received ELMIRON® for 2 years, and 145 (6%) for 4 years.
Frequency ( ≤ ; 1%):
Hypersensitive Reactions: Allergic reaction, photosensitivity.
ELMIRON® was evaluated in a randomized, double-blind, parallel group, Phase 4 study conducted in 380 patients with interstitial cystitis dosed for 32 weeks. At a daily dose of 300 mg (n = 128), rectal hemorrhage was reported as an adverse event in 6.3% of patients. The severity of the events was described as “mild” in most patients. Patients in that study who were administered ELMIRON® 900 mg daily, a dose higher than the approved dose, experienced a higher incidence of rectal hemorrhage, 15%.
Liver Function Abnormality
A randomized, double-blind, parallel group, phase 2 study was conducted in 100 men (51 ELMIRON® and 49 placebo) dosed for 16 weeks. At a daily dose of 900 mg, a dose higher than the approved dose, elevated liver function tests were reported as an adverse event in 11.8% (n = 6) of ELMIRON®-treated patients and 2% (n = 1) of placebo-treated patients.
Read the Elmiron (pentosan polysulfate sodium capsules) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 4/22/2016
Additional Elmiron Information
Elmiron - User Reviews
Elmiron User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.