Dulcolax (polyethylene glycol 3350) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Dulcolax
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Polyethylene glycol 3350
Class: Osmotic laxative
Also reported as: Dulcolax /00064401/, Dulcolax Tablets, Dulcolax Nos

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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 2,893 adverse event reports that name Dulcolax. In these reports the drug is a suspect or interacting product.

In the same period, 8,741 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 137 reports in the 12 months to June 2026 and 86 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 137 (under 0.1%) name Dulcolax. Reports for patients 75 and over were 29.5% of the reports that name Dulcolax and 9.5% of all drug reports.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Dulcolax 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 2 Oct 2026.

Data version

openFDA FAERS release of 29 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 32 reports that name Dulcolax.
In January to March 2026, FDA received 39.
In April to June 2025, FDA received 25.

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 updates Feed 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 284 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 2,851 of the 2,893 reports (98.5%).

The reports of the other years are not in the counts.

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

Find a reaction term

The table shows the first 50 of 284 terms.

Reaction terms in the reports that name Dulcolax, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,893 reports
Constipation	779	26.9%
Drug ineffectivethe medicine did not work as expected	659	22.8%
Painpain, site not specified	480	16.6%
Hypotensionlow blood pressure	416	14.4%
Falla fall	414	14.3%
Balance disorderproblems with balance	390	13.5%
Cognitive disorderproblems with thinking or memory	389	13.4%
Orthostatic hypotension	379	13.1%
Sedationdrowsiness	374	12.9%
Depressed level of consciousness	360	12.4%
Mobility decreasedreduced ability to move about	359	12.4%
Blood calcium decreased	357	12.3%
Creatinine renal clearance decreased	357	12.3%
No adverse eventno adverse event was reported	357	12.3%
Off label useused for a purpose or in a way not on the label	351	12.1%
Sedation complication	343	11.9%
Nauseafeeling sick	339	11.7%
Abdominal painstomach or belly pain	334	11.5%
Vomitingbeing sick	333	11.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	320	11.1%
Diarrhoealoose or frequent stools	256	8.8%
Abdominal distensiona bloated abdomen	231	8%
General physical health deteriorationgeneral decline in health	193	6.7%
Hyponatraemialow blood sodium	191	6.6%
Appendicitis	181	6.3%
Appendicolith	180	6.2%
Ascitesfluid in the abdomen	180	6.2%
Dyspnoeashortness of breath	179	6.2%
Sepsisa severe body-wide response to infection	178	6.2%
Cardiogenic shockshock from the heart failing to pump	177	6.1%
Multiple organ dysfunction syndromeseveral organs failing	175	6%
Stress	172	5.9%
Incorrect route of product administrationthe product was given by the wrong route	160	5.5%
Anaemialow red blood cells	156	5.4%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	153	5.3%
Condition aggravatedthe condition being treated got worse	143	4.9%
Abdominal pain upperupper stomach pain	138	4.8%
Drug abusemisuse of a medicine	138	4.8%
Product use in unapproved indicationused for a purpose not on the label	138	4.8%
Intentional product misusedeliberate use not as intended	137	4.7%
Somnolencedrowsiness	134	4.6%
Blood phosphorus increased	129	4.5%
Dry mouth	128	4.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	113	3.9%
Drug dependencedependence on a medicine	111	3.8%
Drug intolerancethe medicine was not tolerated	110	3.8%
Swelling	109	3.8%
Blood cholesterol increasedraised cholesterol	108	3.7%
Diabetes mellitusdiabetes	108	3.7%
Bacterial infectiona bacterial infection	105	3.6%

Download all 284 terms of Dulcolax (CSV)

The counts add to more than 2,893 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 2 Oct 2026.

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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Polyethylene glycol 3350 with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Polyethylene glycol 3350	Generic name	5,750
Dulcolax (this page)	Brand name	2,893
Gavilax	Brand name	211
MiraLAX	Brand name	38,188

Sum of the separately reported names: 47,042. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

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

Outcomes in the reports that name Dulcolax, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	14	11	1	1	4	0	0	9	3
2005	27	27	1	1	14	0	0	24	0
2006	6	5	0	0	5	0	0	2	1
2007	7	3	0	0	1	0	0	2	4
2008	41	31	2	2	15	1	0	13	10
2009	59	46	0	1	22	2	0	30	13
2010	66	59	2	1	31	0	0	31	7
2011	43	37	2	1	14	1	0	22	6
2012	55	26	2	0	17	0	0	9	29
2013	80	54	6	2	35	0	1	23	26
2014	125	113	3	3	62	1	0	76	12
2015	81	62	4	5	35	3	0	31	19
2016	94	82	3	4	40	1	0	50	12
2017	87	74	3	3	21	1	0	58	13
2018	282	70	5	4	23	0	0	52	212
2019	132	64	2	2	22	0	1	49	68
2020	98	85	0	0	43	2	0	80	13
2021	274	258	32	5	168	1	0	241	16
2022	261	248	43	16	163	22	1	235	13
2023	591	161	58	56	103	51	6	149	430
2024	197	105	25	39	69	21	3	99	92
2025	144	119	31	55	87	31	26	114	25
2026	129	107	53	52	75	50	37	99	22

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 2 Oct 2026.

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 2 Oct 2026.

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 Dulcolax, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Dulcolax, by the year in which FDA received them
Year	Reports
2004	11
2005	31
2006	6
2007	6
2008	43
2009	84
2010	76
2011	44
2012	60
2013	78
2014	93
2015	82
2016	94
2017	99
2018	286
2019	136
2020	132
2021	353
2022	223
2023	615
2024	163
2025	107
2026	71

Reports that name Dulcolax, by month, five years to June 2026

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 Dulcolax
Age	Reports	Share
Under 2	2	0.1%
2 to 11	50	1.7%
12 to 17	12	0.4%
18 to 44	127	4.4%
45 to 64	223	7.7%
65 to 74	211	7.3%
75 and over	854	29.5%
Age not given	1,414	48.9%

Sex of the patient in the reports that name Dulcolax
Sex	Reports	Share
Female	1,646	56.9%
Male	968	33.5%
Unknown or not given	279	9.6%

Type of reporter in the reports that name Dulcolax
Reporter	Reports	Share
Physician	217	7.5%
Pharmacist	26	0.9%
Other health professional	691	23.9%
Lawyer	82	2.8%
Consumer or non-health professional	1,806	62.4%
Not given	71	2.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 60.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dulcolax record
Indication as recorded (MedDRA)	Reports	Share
Constipation	1,077	37.2%
Colonoscopy	129	4.5%
Ventricular fibrillation	30	1%
Bowel preparation	24	0.8%
Bowel movement irregularity	16	0.6%
Child abuse	12	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,893 reports.

Drugs in the same reports

Other drugs that the reports of Dulcolax name, in any role, in order of name
Drug	Reports that name the two
Acebutolol hydrochloride	334
Acetaminophen	678
Albuterol	378
Bisacodyl	351
Carbamazepine	366
Furosemide	397
Lactulose	355
Magnesium hydroxide	374
Morphine sulfate	471
Nitroglycerin	350

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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Polyethylene glycol 3350 same ingredient
Gavilax same ingredient
MiraLAX same ingredient
DIANEAL PD-2 with Dextrose same class
Extraneal same class
DIANEAL Low Calcium with Dextrose same class
Delflex same class
GoLYTELY same class
Dulaglutide next in the A to Z list
Dulcolax Stool Softener next in the A to Z list
Duexis next in the A to Z list
Dulera next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for DulcolaxThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Dulcolax: adverse event reports that FDA received. https://reportedreactions.com/drug/dulcolax/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 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 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Dulcolax as a suspect or interacting product. The 8,741 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 Dulcolax 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 11 Mar 2026. The site read the page on 2 Oct 2026.

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 Dulcolax?

No. It is a count of what people reported to FDA: 2,893 reports from January 2004 to June 2026. 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?

Consumer or non-health professional (62.4%), other health professional (23.9%) and physician (7.5%). 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 2 Oct 2026.

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.

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