Elmiron

Elmiron Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Elmiron (pentosan polysulfate sodium) it is used to treat bladder pain and discomfort caused by cystitis (bladder inflammation or irritation). It is a weak blood thinner and also works as a bladder protectant. Common side effects include diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain.

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. 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. During pregnancy, Elmiron should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Elmiron in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • nosebleed;
  • blood in your urine or stools;
  • rectal bleeding;
  • coughing up blood;
  • bleeding gums; or
  • feeling like you might pass out.

Less serious side effects may include:

  • hair loss;
  • nausea, diarrhea, stomach pain;
  • headache;
  • mild dizziness;
  • depressed mood; or
  • mild itching or skin rash.

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.

Read the entire detailed patient monograph for Elmiron (Pentosan Polysulfate Sodium Capsules) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Elmiron Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual bruising/bleeding (e.g., blood in stool), mental/mood changes, heartburn, discomfort when swallowing.

Tell your doctor immediately if any of these rare but very serious side effects occur: tiredness, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), shortness of breath, vision changes, eye pain, dark urine, yellowing eyes/skin, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Elmiron (Pentosan Polysulfate Sodium Capsules)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Elmiron FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Elmiron (Pentosan Polysulfate Sodium Capsules) »

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Elmiron - User Reviews

Elmiron User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Elmiron sorted by most helpful. Patient Discussions FAQs

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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