Extranealicodextrin
30,670 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Extraneal in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Death 5,997 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →- Peritonitis 1,862 reports
- Peritoneal Dialysis Complication 1,470 reports
- Peritonitis Bacterial 1,466 reports
Hypotension 1,170 reports
Myocardial Infarction 970 reports
The medical term for a heart attack.
Full definition in the glossary →Pneumonia 969 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Infection 788 reports
A general report of an infection, used when no more specific type is given.
Full definition in the glossary →Sepsis 740 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →- Fluid Overload 728 reports
Fall 706 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Dehydration 662 reports
A condition where the body does not have enough water.
Full definition in the glossary →Asthenia 642 reports
Physical weakness or lack of strength.
Full definition in the glossary →Dyspnoea 633 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain 631 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 17,365 |
| Female | 11,718 |
| Unknown | 190 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 359 |
| 18-34 | 578 |
| 35-49 | 1,914 |
| 50-64 | 4,980 |
| 65-74 | 3,594 |
| 75+ | 2,731 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Extraneal. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 14,405 |
| Death | 10,003 |
| Other Serious | 7,173 |
| Non-Serious | 5,028 |
| Life-Threatening | 182 |
| Disability | 76 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Extraneal. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 62 |
| 2005 | 76 |
| 2006 | 78 |
| 2007 | 158 |
| 2008 | 364 |
| 2009 | 670 |
| 2010 | 1,121 |
| 2011 | 1,505 |
| 2012 | 1,649 |
| 2013 | 3,026 |
| 2014 | 4,314 |
| 2015 | 4,658 |
| 2016 | 3,141 |
| 2017 | 2,331 |
| 2018 | 1,252 |
| 2019 | 1,230 |
| 2020 | 1,192 |
| 2021 | 738 |
| 2022 | 711 |
| 2023 | 712 |
| 2024 | 773 |
| 2025 | 737 |
| 2026 (partial) | 172 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026