FDA Adverse Events Reports (FAERS) Summary for ELMIRON

These tables and charts are based on 6,744 total reports for ELMIRON (PENTOSAN POLYSULFATE SODIUM) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 6,576 pharmaceutical company-submitted and non-U.S. FAERS reports and 168 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 168 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch ELMIRON summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with ELMIRON (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	MACULOPATHY	1387
2	OFF LABEL USE	1369
3	RETINAL PIGMENTATION	607
4	DRY AGE-RELATED MACULAR DEGENERATION	562
5	PIGMENTARY MACULOPATHY	455
6	DRUG INEFFECTIVE	328
7	PAIN	292
8	PRODUCT USE ISSUE	271
9	NAUSEA	235
10	HEADACHE	223
11	CYSTITIS INTERSTITIAL	214
12	MACULAR DEGENERATION	214
13	HAIR LOSS	203
14	DIARRHEA	198
15	FATIGUE	196
16	AGE-RELATED MACULAR DEGENERATION	184
17	DEPRESSION	178
18	ANXIETY	175
19	INCORRECT DOSE ADMINISTERED	156
20	DIZZINESS	152
21	VISUAL IMPAIRMENT	151
22	TOXICITY TO VARIOUS AGENTS	148
23	RETINAL DYSTROPHY	143
24	MALAISE	142
25	NEOVASCULAR AGE-RELATED MACULAR DEGENERATION	141
26	VISION BLURRED	119
27	JOINT PAIN	118
28	URINARY TRACT INFECTION	117
29	DRUG DOSE OMISSION	115
30	VOMITING	108
31	RETINOPATHY	107
32	VITREOUS DETACHMENT	100
33	FALL	98
34	WEIGHT DECREASED	98
35	SHORTNESS OF BREATH	96
36	RETINAL DEGENERATION	92
37	LACK OF STRENGTH AND ENERGY (ASTHENIA)	91
38	INSOMNIA	87
39	BLINDNESS	86
40	PAIN IN EXTREMITY	86
41	CONDITION AGGRAVATED	83
42	ABDOMINAL PAIN	82
43	ABDOMINAL PAIN UPPER	82
44	ADVERSE EVENT	81
45	BLADDER PAIN	81
46	ITCHING	78
47	RASH	78
48	BACK PAIN	75
49	ABDOMINAL DISCOMFORT	73
50	FEELING ABNORMAL	72
51	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	72
52	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	72
53	RETINAL INJURY	70
54	WEIGHT INCREASED	67
55	MIGRAINE	66
56	DROWSINESS	66
57	MUSCLE SPASMS	65
58	DRY EYE	63
59	FEVER	63
60	PRODUCT DOSE OMISSION ISSUE	61
61	CONSTIPATION	60
62	HIGH BLOOD PRESSURE	60
63	CYSTITIS	58
64	RETINAL TOXICITY	56
65	SINUSITIS	55
66	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	54
67	CATARACT	53
68	SURGERY	52
69	DECREASED APPETITE	51
70	CHEST PAIN	50
71	COUGH	50
72	GAIT DISTURBANCE	50
73	GASTROOESOPHAGEAL REFLUX DISEASE	50
74	INDIGESTION	48
75	INJECTION SITE PAIN	48
76	PAINFUL URINATION	47
77	URINATION DIFFICULTY	47
78	TREATMENT NONCOMPLIANCE	47
79	CONFUSIONAL STATE	46
80	PINS AND NEEDLES	46
81	DRUG PRESCRIBING ERROR	45
82	NUMBNESS	44
83	DEATH	43
84	BLADDER DISORDER	42
85	CROHN^S DISEASE	42
86	RETINAL DRUSEN	42
87	BLOOD PRESSURE INCREASED	41
88	PNEUMONIA	41
89	COLITIS ULCERATIVE	39
90	EXCESS SWEATING	39
91	HYPERSENSITIVITY	38
92	JOINT SWELLING	38
93	DELAYED DARK ADAPTATION	37
94	DRY MOUTH	37
95	MUSCLE PAIN	37
96	PALPITATIONS	37
97	CATARACT NUCLEAR	36
98	WRONG TECHNIQUE IN DRUG USAGE PROCESS	36
99	ANEMIA	35
100	ASTHMA	35

Latest Known Outcomes for Reactions Reported for ELMIRON

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4767
2	Patient has not recovered/symtoms have not resolved	2161
3	Patient recovered	676
4	Patient is recovering/symptoms resolving	408
5	Patient died	48
6	Patient has recovered but has consequent health issues	13

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	37
2005	51
2006	55
2007	54
2008	62
2009	61
2010	111
2011	166
2012	160
2013	151
2014	174
2015	558
2016	356
2017	271
2018	317
2019	326
2020	493
2021	658
2022	1529
2023	589
2024	314
2025	190
2026	61

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	627
11-20	30
21-30	151
31-40	355
41-50	585
51-60	730
61-70	691
71-80	352
81-90	96
91+	16

Based on 3633 reports that included a patient age.

ELMIRON Total Reports

Male	Female	Unknown	Total
537	5868	339	6,744

Top Countries Reporting

	Country	Number of Reports
1	United States	5732
2	Canada	223
3	Puerto Rico	28
4	Poland	7
5	Georgia	6
6	EU	3
7	United Kingdom	3
8	France	2
9	Turkey	2
10	Germany	1

Outcomes for Reports

Serious: 4707
Not Serious: 2036
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

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

Top Companies Reporting

JOHNSON AND JOHNSON

Safety-Related FDA Updates

FDA Approval Date: 1996-09-26

ELMIRON (PENTOSAN POLYSULFATE SODIUM) Rx Drug:
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

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for ELMIRON reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.