Elmiron
SIDE EFFECTS
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® n=128 | Placebo n=130 |
| CNS Overall Number of Patients* | 3 | 5 |
| Insomnia Headache Severe Emotional Lability/Depression Nystagmus/Dizziness Hyperkinesia | 1 1 2 1 1 | 0 3 1 1 1 |
| GI Overall Number of Patients* | 7 | 7 |
| Nausea Diarrhea Dyspepsia Jaundice Vomiting | 3 3 1 0 0 | 3 6 0 1 2 |
| Skin / Allergic Overall Number of Patients* | 2 | 4 |
| Rash Pruritus Lacrimation Rhinitis Increased Sweating | 0 0 1 1 1 | 2 2 1 1 0 |
| Other Overall Number of Patients* | 1 | 3 |
| Amenorrhea Arthralgia Vaginitis | 0 0 1 | 1 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®. 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 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.
DRUG INTERACTIONS
Drug-Drug Interactions: Not studied.
Generic Name: Pentosan
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.
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Elmiron
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