Medical Editor: John P. Cunha, DO, FACOEP
What Is Elmiron?
Elmiron (pentosan polysulfate sodium) is a weak blood thinner and also works as a bladder protectant used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation).
What Are Side Effects of Elmiron?
Elmiron may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- nosebleed,
- blood in your urine or stools,
- rectal bleeding,
- coughing up blood,
- bleeding gums, and
- lightheadedness
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Elmiron include:
- diarrhea,
- hair loss,
- nausea,
- headache,
- stomach upset or pain,
- abdominal pain,
- dizziness,
- depressed mood, or
- itching or skin rash.
Tell your doctor if you have unlikely but serious side effects of Elmiron including:
- unusual bruising or bleeding (e.g., blood in stool),
- mental/mood changes,
- heartburn, or
- discomfort when swallowing.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Elmiron
The recommended dose of Elmiron is 300 mg/day taken as one 100 mg capsule orally three times daily. Take with water 1 hour before meals or 2 hours after meals.
What Drugs, Substances, or Supplements Interact with Elmiron?
Elmiron may interact with aspirin, alteplase, anistreplase, clopidogrel, dipyridamole, streptokinase, ticlopidine, urokinase, or NSAIDs (non-steroidal anti-inflammatory drugss). Tell your doctor all medications and supplements you use.
Elmiron During Pregnancy and Breastfeeding
During pregnancy, Elmiron should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Elmiron (pentosan polysulfate sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Urinary Incontinence in Women: Types, Causes, and Treatments for Bladder Control See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- nosebleeds, bleeding gums;
- blood in your urine or stools;
- rectal bleeding;
- coughing up blood;
- a light-headed feeling, like you might pass out; or
- vision problems (blurred vision, trouble reading, trouble seeing in low light).
Common side effects may include:
- bruising, blood in your stools;
- hair loss;
- nausea, diarrhea, upset stomach;
- headache;
- swelling, weight gain;
- dizziness;
- rash; or
- abnormal liver function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 | 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 |
| * 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.
Post-Marketing Experience
The following adverse reactions have been identified during post approval use of pentosan polysulfate sodium; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
- pigmentary changes in the retina (see WARNINGS).
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.
Read the entire FDA prescribing information for Elmiron (Pentosan Polysulfate Sodium Capsules)
© Elmiron Patient Information is supplied by Cerner Multum, Inc. and Elmiron Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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