Elmiron Side Effects

Generic Name: pentosan polysulfate sodium

Please note - some side effects for Elmiron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Elmiron - for the Consumer

Elmiron

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elmiron:

Diarrhea; dizziness; hair loss; headache; nausea; stomach upset; swelling of fingers, hands, toes, or feet.

Seek medical attention right away if any of these SEVERE side effects occur when using Elmiron:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; unusual bruising or bleeding; vomiting that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Elmiron Side Effects - for the Professional

Elmiron

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
* 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.
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
GI 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

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.

Post-Marketing Experience

Rectal Hemorrhage

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.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. These have included nausea, diarrhea, dyspepsia, vomiting, and rectal hemorrhage.

In a phase 4 study of patients with interstitial cystitis (n=380) taking pentosan polysulfate sodium, the incidence of rectal hemorrhage was reported at 15% in patients taking doses of 900 mg/day versus 6.3% in patients taking the recommended daily dosage of 300 mg/day.

Dermatologic

Dermatologic side effects have included alopecia, pruritus, and urticaria.

Nervous system

Nervous system side effects have included headache (3%) and dizziness (1%). Hyperkinesia, insomnia, and depression have also been reported.

Hematologic

Hematologic side effects have included anemia, ecchymosis, increased prothrombin time, increased partial thromboplastin time, and thrombocytopenia.

There have been case reports of thrombocytopenia similar to heparin induced thrombocytopenia associated with a parenteral form of pentosan polysulfate sodium. It should be used with caution in patients with a history of heparin induced thrombocytopenia.

Hepatic

Hepatic side effects have included liver function abnormalities: mildly elevated (<2.5 normal) transaminase, alkaline phosphatase, gamma-glutamyl transpeptidase, and lactic dehydrogenase.

Respiratory

Respiratory side effects have included pharyngitis, rhinitis, epistaxis, and dyspnea.

Ocular

Ocular side effects have included conjunctivitis, optic neuritis, amblyopia, and retinal hemorrhage.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions and photosensitivity.

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