Brand name · Sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose
DIANEAL PD-2 with Dextrose: adverse event reports filed with FDA
7,178 reports list it as a suspect or interacting product, 2011–2026. Class: Osmotic laxative.
- 7,178
- reports as suspect product
- 0% of all reports · about 466 a year
- 161
- reports, 12 months to June 2026
- 151 in the 12 months before
- 88.6%
- marked serious by the reporter
- 54.5% across the class
- 45.5%
- record death among outcomes, as reported
- 3,268 reports · not verified by FDA
Between February 2011 and June 2026, 7,178 adverse event reports received by FDA list the brand name DIANEAL PD-2 with Dextrose (sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose) as a suspect or interacting product. Reports that mention it only as a concomitant medication (0) are left out of every figure here.
In the 12 months to June 2026, 161 reports listed it, close to the 151 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 466 reports a year and 0% of the 20,646,523 reports in the database, and 5.5% 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 (13.8%), peritonitis (7.1%) and myocardial infarction (6.9%). A report can list several reactions, so shares add to more than 100%; 502 different terms appear across these reports. Death is recorded in 13.8% of these reports, a larger share than in the median osmotic laxative drug (2.4%).
88.6% of the reports are marked serious by the reporter (54.5% across the class); 45.5% record death among the outcomes and 50.9% record hospitalisation, as reported. 54.4% of the reports came from consumers, and the largest patient age group is 45 to 64 (22.7%). 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 DIANEAL PD-2 with Dextrose reports recording the termmedian drug in osmotic laxative
- Deaththe patient died; cause not stated by this term13.8%987
- Peritonitis7.1%512
- Myocardial infarctionheart attack6.9%492
- Cardiac failure congestivecongestive heart failure5.8%415
- Sepsisa severe body-wide response to infection5%362
- Infectionan infection, type not specified4.8%347
- Hypotensionlow blood pressure4.6%331
- Cardio-respiratory arrestthe heart and breathing stopped4.5%321
- Acute myocardial infarction4.1%295
- Pneumonialung infection3.2%232
- Fluid overload3%216
- Peritonitis bacterial2.8%199
- Astheniaweakness or lack of energy2.5%178
- Ultrafiltration failure2.2%160
- General physical health deteriorationgeneral decline in health2.2%155
- Dehydrationdehydration2.1%152
- Vomitingbeing sick2.1%151
- Dyspnoeashortness of breath2.1%149
- Cerebrovascular accidentstroke2%146
- Hypertensionhigh blood pressure2%145
- Device related infectionan infection related to the device1.9%135
- Cardiac disorder1.8%126
- Cardiac failureheart failure1.8%126
- Abdominal painstomach or belly pain1.6%115
- Pulmonary oedemafluid in the lungs1.5%110
- Diabetic footfoot problems from diabetes1.5%108
- Swellingswelling1.4%104
- Cardiac arrestthe heart stopped1.4%102
- Falla fall1.3%95
Top 30 of 502 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. 34.1% 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 | 5,139 | 71.6% |
| Chronic kidney disease | 1,311 | 18.3% |
| Renal failure | 388 | 5.4% |
| End stage renal disease | 110 | 1.5% |
| Renal failure chronic | 54 | 0.8% |
| Diabetic nephropathy | 3 | 0% |
The indication field is filled in by the reporter and is often blank; shares are of all 7,178 reports.
In context
| Measure | DIANEAL PD-2 with Dextrose | Osmotic laxative | All reports |
|---|---|---|---|
| Reports as suspect product | 7,178 | 129,514 | 20,646,523 |
| Share of that pool | — | 5.5% | 0% |
| Reports, latest 12 months | 161 | — | 1,332,454 |
| Marked serious | 88.6% | 54.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 455 | 152 | 91 |
| Hospitalisation recorded, per 1,000 reports | 509 | 286 | 213 |
| Consumer-filed share | 54.4% | 61% | 45.8% |
| Top term, share of reports | Death 13.8% | 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% |
| Extraneal | brand | 30,830 | 733 | 83.6% |
| Sodium chloride | generic | 11,044 | 1,389 | 92.5% |
| Delflex | brand | 8,765 | 676 | 53.8% |
| Potassium chloride | generic | 8,172 | 518 | 86.4% |
| 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 DIANEAL PD-2 with Dextrose reports
How many adverse event reports has FDA received for DIANEAL PD-2 with Dextrose?
7,178 reports list DIANEAL PD-2 with Dextrose as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 161 of them arrived in the latest 12 months. Another 0 list it only as a concomitant medication.
What reactions are recorded in DIANEAL PD-2 with Dextrose reports?
death (13.8%), peritonitis (7.1%), myocardial infarction (6.9%), cardiac failure congestive (5.8%) and sepsis (5%). 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 DIANEAL PD-2 with Dextrose was responsible.
How serious are the reports?
88.6% are marked serious by the reporter. Among the outcomes recorded, 45.5% of reports include death and 50.9% 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 (54.4%), other health professional (44.3%) and physician (1.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for DIANEAL PD-2 with Dextrose rising?
161 reports in the 12 months to June 2026, close to the 151 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 DIANEAL PD-2 with Dextrose 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 DIANEAL PD-2 with Dextrose?
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 DIANEAL PD-2 with Dextrose as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.