Elmiron

Elmiron

SIDE EFFECTS

ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® and which events are associated with concurrent illness, medicine, or other factors.

Adverse Experience In Placebo-Controlled Clinical Trials of ELMIRON (pentosan polysulfate sodium capsules) ® 100 mg Three Times a Day for 3 Months

Body System/ Adverse Experience ELMIRON®
n=128
Placebo
n=130
CNS Overall Number of Patients* 3 5
   Insomnia 1 0
   Headache 1 3
   Severe Emotional Lability/Depression 2 1
   Nystagmus/Dizziness 1 1
   Hyperkinesia 1 1
Gl Overall Number of Patients* 7 7
   Nausea 3 3
   Diarrhea 3 6
   Dyspepsia 1 0
   Jaundice 0 1
   Vomiting 0 2
Skin/Allergic Overall Number of Patients* 2 4
   Rash 0 2
   Pruritus 0 2
   Lacrimation 1 1
   Rhinitis 1 1
   Increased Sweating 1 0
Other Overall Number of Patients* 1 3
   Amenorrhea 0 1
   Arthralgia 0 1
   Vaginitis 1 1
Total Events 17 27
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 (pentosan polysulfate sodium capsules) ®. Of the original 2499 patients, 1192 (48%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 3 months; 892 (36%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 6 months; and 598 (24%) received ELMIRON (pentosan polysulfate sodium capsules) ® for one year, 355 (14%) received ELMIRON (pentosan polysulfate sodium capsules) ® for 2 years, and 145 (6%) for 4 years.

Frequency (1 to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%). dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), dizziness (1%).

Frequency ( < 1 %)

Digestive: Vomiting, mouth ulcer, colitis, esophagitis, gastritis, flatulence, constipation, anorexia, gum hemorrhage.

Hematologic: Anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, leukopenia, thrombocytopenia.

Hypersensitive Reactions: Allergic reaction, photosensitivity.

Respiratory System: Pharyngitis, rhinitis, epistaxis, dyspnea.

Skin and Appendages: Pruritus, urticaria.

Special Senses: Conjunctivitis, tinnitus, optic neuritis, amblyopia, retinal hemorrhage.

Post-Marketing Experience

Rectal Hemorrhage: ELMIRON (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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 (pentosan polysulfate sodium capsules) ® 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

DRUG INTERACTIONS

No information provided.

Read the Elmiron Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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