Lactulose adverse event reports that FDA received

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

Name type: Generic name
Class: Osmotic laxative
Also reported as: Lactulose 30 Ml, Lactulose Oral Solution, Lactulose Syrup

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 4,133 adverse event reports that name Lactulose. In these reports the drug is a suspect or interacting product.

In the same period, 32,982 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 353 reports in the 12 months to June 2026 and 304 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, 353 (under 0.1%) name Lactulose. Reports from other health professionals were 39.3% of the reports that name Lactulose and 19.7% 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 Lactulose 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 55 reports that name Lactulose.
In January to March 2026, FDA received 94.
In April to June 2025, FDA received 91.

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 521 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 4,093 of the 4,133 reports (99%).

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 521 terms.

Reaction terms in the reports that name Lactulose, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,133 reports
Constipation	865	20.9%
Falla fall	852	20.6%
Cognitive disorderproblems with thinking or memory	671	16.2%
Balance disorderproblems with balance	662	16%
Hypotensionlow blood pressure	651	15.8%
Orthostatic hypotension	611	14.8%
Painpain, site not specified	604	14.6%
Sedationdrowsiness	596	14.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	576	13.9%
Depressed level of consciousness	565	13.7%
Mobility decreasedreduced ability to move about	551	13.3%
Sedation complication	534	12.9%
Blood calcium decreased	520	12.6%
Creatinine renal clearance decreased	519	12.6%
Diarrhoealoose or frequent stools	403	9.8%
Drug ineffectivethe medicine did not work as expected	386	9.3%
Dyspnoeashortness of breath	340	8.2%
Nauseafeeling sick	280	6.8%
Off label useused for a purpose or in a way not on the label	260	6.3%
Vomitingbeing sick	234	5.7%
Drug interactionan interaction between medicines	208	5%
Confusional stateconfusion	189	4.6%
Product use in unapproved indicationused for a purpose not on the label	165	4%
Pyrexiafever	148	3.6%
Malaisegeneral feeling of being unwell	147	3.6%
General physical health deteriorationgeneral decline in health	143	3.5%
Headachehead pain	140	3.4%
Abdominal painstomach or belly pain	134	3.2%
Acute kidney injurysudden loss of kidney function	132	3.2%
Weight decreasedweight loss	130	3.1%
Astheniaweakness or lack of energy	129	3.1%
Deaththe patient died; cause not stated by this term	126	3%
Dizzinesslight-headedness or unsteadiness	124	3%
Ammonia increased	123	3%
Fatiguetiredness	121	2.9%
Pneumonialung infection	120	2.9%
Dehydration	119	2.9%
Anaemialow red blood cells	117	2.8%
Productive cougha cough with phlegm	117	2.8%
Toxic epidermal necrolysisa severe skin reaction with peeling	117	2.8%
Overdosea dose above the recommended amount	116	2.8%
Decreased appetitereduced appetite	109	2.6%
Cough	108	2.6%
Condition aggravatedthe condition being treated got worse	107	2.6%
Chest pain	100	2.4%
Abdominal distensiona bloated abdomen	98	2.4%
Insomniadifficulty sleeping	94	2.3%
Seizurea fit or convulsion	93	2.3%
Somnolencedrowsiness	91	2.2%
Abdominal discomfortstomach discomfort	89	2.2%

Download all 521 terms of Lactulose (CSV)

The counts add to more than 4,133 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.

Outcomes by year

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

Outcomes in the reports that name Lactulose, 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	13	12	4	2	6	0	0	4	1
2005	47	43	26	0	5	1	0	17	4
2006	26	25	14	2	9	0	0	3	1
2007	38	37	12	2	13	0	1	15	1
2008	54	50	8	2	35	1	1	18	4
2009	25	23	10	4	9	0	0	9	2
2010	43	42	5	4	19	0	18	11	1
2011	25	20	7	0	8	2	0	10	5
2012	62	57	12	4	25	3	4	33	5
2013	84	60	4	1	34	8	0	28	24
2014	68	54	16	10	28	1	0	28	14
2015	92	79	13	3	36	0	0	55	13
2016	170	127	31	5	54	2	4	77	43
2017	160	125	35	9	60	3	1	69	35
2018	228	170	17	20	105	2	0	108	58
2019	278	242	48	18	119	1	2	145	36
2020	317	287	20	25	183	3	0	198	30
2021	590	555	62	40	396	2	1	451	35
2022	456	417	21	29	310	2	0	364	39
2023	394	336	89	81	226	9	0	231	58
2024	319	270	29	48	140	12	0	196	49
2025	400	350	34	57	163	17	17	291	50
2026	244	217	26	36	117	2	29	158	27

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 Lactulose, 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 Lactulose, by the year in which FDA received them
Year	Reports
2004	13
2005	45
2006	29
2007	45
2008	52
2009	26
2010	45
2011	28
2012	69
2013	79
2014	78
2015	97
2016	182
2017	186
2018	273
2019	297
2020	371
2021	655
2022	393
2023	341
2024	310
2025	370
2026	149

Reports that name Lactulose, 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 Lactulose
Age	Reports	Share
Under 2	42	1%
2 to 11	78	1.9%
12 to 17	13	0.3%
18 to 44	356	8.6%
45 to 64	838	20.3%
65 to 74	587	14.2%
75 and over	1,158	28%
Age not given	1,061	25.7%

Sex of the patient in the reports that name Lactulose
Sex	Reports	Share
Female	2,238	54.1%
Male	1,392	33.7%
Unknown or not given	503	12.2%

Type of reporter in the reports that name Lactulose
Reporter	Reports	Share
Physician	840	20.3%
Pharmacist	295	7.1%
Other health professional	1,626	39.3%
Lawyer	2	under 0.1%
Consumer or non-health professional	1,102	26.7%
Not given	268	6.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 36% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lactulose record
Indication as recorded (MedDRA)	Reports	Share
Constipation	1,005	24.3%
Hepatic encephalopathy	154	3.7%
Hyperammonaemia	62	1.5%
Ill-defined disorder	45	1.1%
Hepatic cirrhosis	43	1%
Thyroid disorder	34	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,133 reports.

Drugs in the same reports

Other drugs that the reports of Lactulose name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	1,008
Aspirin	625
Carbamazepine	659
Furosemide	1,188
Magnesium hydroxide	618
Morphine sulfate	640
Nitroglycerin	602
Omeprazole	955
Oxazepam	629
Tiotropium bromide	739

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

Lactated Ringers same class
MiraLAX same class
Klor-Con same class
Polyethylene glycol same class
GoLYTELY same class
Polyethylene glycol 3350 same class
Lactobacillus Acidophilus next in the A to Z list
Lagevrio next in the A to Z list
Lamaline next in the A to Z list
Lactated Ringer's next in the A to Z list
Lamictal next in the A to Z list
Lacrisert 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 LactuloseThe 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. Lactulose: adverse event reports that FDA received. https://reportedreactions.com/drug/lactulose/ 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 Lactulose as a suspect or interacting product. The 32,982 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 Lactulose 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 Lactulose?

No. It is a count of what people reported to FDA: 4,133 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?

Other health professional (39.3%), consumer or non-health professional (26.7%) and physician (20.3%). 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 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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