Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Dianeal Pd 2 with Dextrose adverse event reports that FDA received

Name type
Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From May 2018 to September 2021, FDA received 302 adverse event reports that name Dianeal Pd 2 with Dextrose. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 0 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Dianeal Pd 2 with Dextrose is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

FDA received no report that names Dianeal Pd 2 with Dextrose in April to June 2026, in January to March 2026 or in April to June 2025.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updatesFeed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 24 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 302 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

The table shows all 24 terms.

Reaction terms in the reports that name Dianeal Pd 2 with Dextrose, most reports first
Reaction term (MedDRA) and plain meaningReportsShare of the 302 reports
Deaththe patient died; cause not stated by this term4715.6%
Cardio-respiratory arrestthe heart and breathing stopped4213.9%
Covid-19COVID-19 infection289.3%
Acute myocardial infarction247.9%
Sepsisa severe body-wide response to infection175.6%
General physical health deteriorationgeneral decline in health155%
Pneumonialung infection155%
Diabetic footfoot problems from diabetes124%
Hypotensionlow blood pressure113.6%
Peritonitis103.3%
Cardiac failureheart failure93%
Diarrhoealoose or frequent stools93%
Hypertensionhigh blood pressure93%
Cardiovascular disorder82.6%
Dyspnoeashortness of breath72.3%
Pulmonary oedemafluid in the lungs72.3%
Urinary tract infectionbladder or urinary infection72.3%
Disease complication62%
Respiratory failurethe lungs could not supply enough oxygen62%
Astheniaweakness or lack of energy51.7%
Dehydration51.7%
Muscle spasmsmuscle cramps51.7%
Product availability issuethe product was not available51.7%
Seizurea fit or convulsion51.7%

Download all 24 terms of Dianeal Pd 2 with Dextrose (CSV)

The counts add to more than 302 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Dianeal Pd 2 with Dextrose, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA fileReportsSeriousDeathLife-threateningHospitalization (initial or prolonged)Disability or Permanent DamageCongenital Anomaly/Birth DefectOther Serious (Important Medical Events)Not serious
201897947905010163
20208883680500095
202111710768163001510

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition

Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Dianeal Pd 2 with Dextrose, by the year in which FDA received them
0100200201820202021
Show the figures of the chart as a table
Reports that name Dianeal Pd 2 with Dextrose, by the year in which FDA received them
YearReports
201897
202093
2021112
Reports that name Dianeal Pd 2 with Dextrose, by month, five years to June 2026
0102020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Dianeal Pd 2 with Dextrose
AgeReportsShareShare as a bar
Under 200%
2 to 1120.7%
12 to 1731%
18 to 44186%
45 to 648829.1%
65 to 746521.5%
75 and over4213.9%
Age not given8427.8%
Sex of the patient in the reports that name Dianeal Pd 2 with Dextrose
SexReportsShareShare as a bar
Female14347.4%
Male15752%
Unknown or not given20.7%
Type of reporter in the reports that name Dianeal Pd 2 with Dextrose
ReporterReportsShareShare as a bar
Physician41.3%
Pharmacist00%
Other health professional22072.8%
Lawyer00%
Consumer or non-health professional7825.8%
Not given00%

Age and sex are as the report gives them. The reporter is the primary source in the report. 9.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dianeal Pd 2 with Dextrose record
Indication as recorded (MedDRA)ReportsShare
Peritoneal dialysis17156.6%
Chronic kidney disease11237.1%
End stage renal disease113.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 302 reports.

Drugs in the same reports

Other drugs that the reports of Dianeal Pd 2 with Dextrose name, in any role, in order of name
DrugReports that name the two
Amlodipine15
Aspirin13
Atorvastatin14
Calcium21
Carvedilol22
Folic acid16
Furosemide28
Insulin18
Levothyroxine18
Losartan37

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pages near this one

These links are for navigation. No count selected them.

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Dianeal Pd 2 with Dextrose: adverse event reports that FDA received. https://reportedreactions.com/drug/dianeal-pd-2-with-dextrose-2/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Dianeal Pd 2 with Dextrose as a suspect or interacting product. The 0 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Dianeal Pd 2 with Dextrose was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Dianeal Pd 2 with Dextrose?

No. It is a count of what people reported to FDA: 302 reports from May 2018 to September 2021. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (72.8%), consumer or non-health professional (25.8%) and physician (1.3%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.