Brand name · Icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride
Extraneal: adverse event reports filed with FDA
30,830 reports list it as a suspect or interacting product, 2004–2026. Class: Osmotic laxative.
- 30,830
- reports as suspect product
- 0.2% of all reports · about 1,371 a year
- 733
- reports, 12 months to June 2026
- 782 in the 12 months before
- 83.6%
- marked serious by the reporter
- 54.5% across the class
- 32.6%
- record death among outcomes, as reported
- 10,038 reports · not verified by FDA
Between January 2004 and June 2026, 30,830 adverse event reports received by FDA list the brand name Extraneal (icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride) as a suspect or interacting product. Reports that mention it only as a concomitant medication (34) are left out of every figure here.
In the 12 months to June 2026, 733 reports listed it, close to the 782 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,371 reports a year and 0.2% of the 20,646,523 reports in the database, and 23.8% of the reports for the osmotic laxative class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are death (19.5%), peritonitis (6.1%) and peritonitis bacterial (4.8%). A report can list several reactions, so shares add to more than 100%; 1,063 different terms appear across these reports. Death is recorded in 19.5% of these reports, a larger share than in the median osmotic laxative drug (2.4%).
83.6% of the reports are marked serious by the reporter (54.5% across the class); 32.6% record death among the outcomes and 47% record hospitalisation, as reported. 60.6% of the reports came from consumers, and the largest patient age group is 45 to 64 (19.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Extraneal reports recording the termmedian drug in osmotic laxative
- Deaththe patient died; cause not stated by this term19.5%6,008
- Peritonitis6.1%1,877
- Peritonitis bacterial4.8%1,483
- Peritoneal dialysis complication4.8%1,482
- Hypotensionlow blood pressure3.8%1,177
- Pneumonialung infection3.1%971
- Myocardial infarctionheart attack3.1%970
- Infectionan infection, type not specified2.6%796
- Sepsisa severe body-wide response to infection2.4%738
- Fluid overload2.3%723
- Falla fall2.3%709
- Dehydrationdehydration2.1%661
- Abdominal painstomach or belly pain2.1%651
- Astheniaweakness or lack of energy2.1%650
- Dyspnoeashortness of breath2.1%639
- Cardiac disorder2%623
- Vomitingbeing sick2%611
- Peritoneal cloudy effluent2%608
- Cardiac failureheart failure1.9%580
- Malaisegeneral feeling of being unwell1.9%580
- Cerebrovascular accidentstroke1.9%578
- Cardiac arrestthe heart stopped1.8%566
- Drug hypersensitivityan allergic-type reaction to a medicine1.8%557
- Rashskin rash1.7%530
- Hypertensionhigh blood pressure1.6%492
- Ultrafiltration failure1.5%470
- Abdominal distensiona bloated abdomen1.5%466
- Fluid retentionthe body holding extra fluid1.5%460
- Procedural painpain from a procedure1.4%437
- Nauseafeeling sick1.4%421
Top 30 of 1,063 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 17 drugs in the osmotic laxative class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 129,514 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 51.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Peritoneal dialysis | 23,674 | 76.8% |
| Chronic kidney disease | 1,379 | 4.5% |
| Renal failure | 1,322 | 4.3% |
| Renal failure chronic | 1,235 | 4% |
| End stage renal disease | 900 | 2.9% |
| Diabetic nephropathy | 60 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 30,830 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Extraneal reports |
|---|---|---|
| Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose | 9,665 | 31.3% |
| Dianeal | 4,622 | 15% |
| Peritoneal Dialysis Solution with 2 5% Dextrose | 335 | 1.1% |
| Dianeal Low Calcium Peritoneal Dialysis Solution with 2 5 | 299 | 1% |
| Insulin | 289 | 0.9% |
| Aspirin | 204 | 0.7% |
| Furosemide | 173 | 0.6% |
| Peritoneal Dialysis Solution with 1 5% Dextrose | 171 | 0.6% |
| Epogen | 150 | 0.5% |
| Lasix | 148 | 0.5% |
Other products listed in reports where Extraneal is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Extraneal | Osmotic laxative | All reports |
|---|---|---|---|
| Reports as suspect product | 30,830 | 129,514 | 20,646,523 |
| Share of that pool | — | 23.8% | 0.2% |
| Reports, latest 12 months | 733 | — | 1,332,454 |
| Marked serious | 83.6% | 54.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 326 | 152 | 91 |
| Hospitalisation recorded, per 1,000 reports | 470 | 286 | 213 |
| Consumer-filed share | 60.6% | 61% | 45.8% |
| Top term, share of reports | Death 19.5% | median 2.4% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the osmotic laxative class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| MiraLAX | brand | 38,188 | 1,721 | 7.2% |
| Sodium chloride | generic | 11,044 | 1,389 | 92.5% |
| Delflex | brand | 8,765 | 676 | 53.8% |
| Potassium chloride | generic | 8,172 | 518 | 86.4% |
| DIANEAL PD-2 with Dextrose | brand | 7,178 | 161 | 88.6% |
| Polyethylene glycol 3350 | generic | 5,750 | 726 | 17.8% |
| Lactulose | generic | 4,133 | 353 | 87.1% |
| SUPREP Bowel Prep | brand | 3,664 | 35 | 9.1% |
| Sodium bicarbonate | generic | 3,342 | 308 | 92.1% |
| Dulcolax | brand | 2,893 | 137 | 63.8% |
| Sutab | brand | 1,513 | 151 | 12% |
| Bss | brand | 1,047 | 41 | 89.6% |
| DIANEAL Low Calcium with Dextrose | brand | 970 | 26 | 97.4% |
| Polyethylene glycol | generic | 760 | 58 | 85.5% |
| Sodium bicarbonate, sodium chloride | generic | 675 | 29 | 100% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Extraneal reports
How many adverse event reports has FDA received for Extraneal?
30,830 reports list Extraneal as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 733 of them arrived in the latest 12 months. Another 34 list it only as a concomitant medication.
What reactions are recorded in Extraneal reports?
death (19.5%), peritonitis (6.1%), peritonitis bacterial (4.8%), peritoneal dialysis complication (4.8%) and hypotension (3.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Extraneal was responsible.
How serious are the reports?
83.6% are marked serious by the reporter. Among the outcomes recorded, 32.6% of reports include death and 47% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (60.6%), other health professional (33.5%) and physician (5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Extraneal rising?
733 reports in the 12 months to June 2026, close to the 782 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Extraneal was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Extraneal?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Extraneal as a suspect or interacting product; reports listing it only as a concomitant medication (34) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.