Drug Safety Information for ELMIRON (Pentosan polysulfate sodium)
Safety-related Labeling Changes for ELMIRON (PENTOSAN POLYSULFATE SODIUM) Rx Drug: FDA Link
Adverse Drug Reactions for ELMIRON* (Pentosan polysulfate sodium)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with ELMIRON
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug ineffective | 128 |
2 | Nausea* | 119 |
3 | Pain* | 105 |
4 | Headache* | 93 |
5 | Fatigue | 91 |
6 | Diarrhoea* | 91 |
7 | Alopecia* | 80 |
8 | Cystitis interstitial | 76 |
9 | Dizziness | 74 |
10 | Drug dose omission | 64 |
11 | Weight decreased | 63 |
12 | Vomiting | 60 |
13 | Incorrect dose administered | 55 |
14 | Urinary tract infection | 51 |
15 | Inappropriate schedule of drug administration | 51 |
16 | Dyspnoea | 50 |
17 | Arthralgia | 48 |
18 | Malaise | 45 |
19 | Abdominal pain | 43 |
20 | Abdominal pain upper | 43 |
* This side effect also appears in "Top 10 Side Effects of ELMIRON " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ELMIRON
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Cystitis interstitial | 2344 |
2 | Product used for unknown indication | 672 |
3 | Bladder disorder | 256 |
4 | Cystitis | 191 |
5 | Bladder pain* | 113 |
6 | Cystitis noninfective | 43 |
7 | Bladder spasm | 31 |
8 | Urinary tract disorder | 22 |
9 | Urinary incontinence | 21 |
10 | Bladder discomfort | 17 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ELMIRON
Total Reports Filed with FDA: 6691
Number of FDA Adverse Event Reports by Patient Age for ELMIRON
Total Reports Filed with FDA: 6691*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pentosan polysulfate sodium (Pentosan, Pentosan polysulfate, Hemoclar, Elmiron)
Charts are based on 6691 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and ELMIRON Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.