ELMIRON FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 168 U.S. reports for ELMIRON (PENTOSAN POLYSULFATE SODIUM) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS ELMIRON Report.

Top Adverse Events Reported with ELMIRON (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	HEADACHE	13
2	MACULOPATHY	12
3	FATIGUE	10
4	NAUSEA	9
5	DIZZINESS	8
6	SHORTNESS OF BREATH	8
7	LARGE INTESTINE POLYP	8
8	HAIR LOSS	7
9	LACK OF STRENGTH AND ENERGY (ASTHENIA)	7
10	BLOOD PRESSURE INCREASED	7
11	COLITIS ULCERATIVE	6
12	DIARRHEA	6
13	DRUG INEFFECTIVE	6
14	RETINAL INJURY	6
15	ABDOMINAL PAIN UPPER	5
16	DEHYDRATION	5
17	GAIT DISTURBANCE	5
18	NUMBNESS	5
19	MACULAR DEGENERATION	5
20	PAIN	5
21	PIGMENTARY MACULOPATHY	5
22	TOXICITY TO VARIOUS AGENTS	5
23	JOINT PAIN	4
24	COLITIS	4
25	CONDITION AGGRAVATED	4

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ELMIRON Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
19	145	4	168

Medwatch Reporter Type	Count
Consumer	96
Physician	13
Pharmacist	10
Other Health Professional	17

Top Indications

Cystitis interstitial
Product used for unknown indication
Bladder disorder
Bladder pain
Urinary tract infection

Type of Outcome Reported
Serious: 127
Not Serious: 41
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 168
Concomitant Drugs: 125
Note: A single MedWatch report can list more than one drug. This summary includes ELMIRON identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

ELMIRON (PENTOSAN POLYSULFATE SODIUM) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with ELMIRON? Rate ELMIRON at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.