Mannitol adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Mannitol Injection Usp

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 July 2004 to June 2026, FDA received 1,569 adverse event reports that name Mannitol. In these reports the drug is a suspect or interacting product.

In the same period, 3,287 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 165 reports in the 12 months to June 2026 and 189 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, 165 (under 0.1%) name Mannitol. Reports from consumers or other non-health professionals were 4.8% of the reports that name Mannitol and 45.8% 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 Mannitol 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 36 reports that name Mannitol.
In January to March 2026, FDA received 43.
In April to June 2025, FDA received 44.

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 259 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 1,519 of the 1,569 reports (96.8%).

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 259 terms.

Reaction terms in the reports that name Mannitol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,569 reports
Drug ineffectivethe medicine did not work as expected	290	18.5%
Condition aggravatedthe condition being treated got worse	212	13.5%
Off label useused for a purpose or in a way not on the label	183	11.7%
Hyponatraemialow blood sodium	176	11.2%
Nauseafeeling sick	166	10.6%
Vomitingbeing sick	154	9.8%
Multiple organ dysfunction syndromeseveral organs failing	153	9.8%
Sepsisa severe body-wide response to infection	153	9.8%
Somnolencedrowsiness	148	9.4%
General physical health deteriorationgeneral decline in health	145	9.2%
Abdominal painstomach or belly pain	141	9%
Stress	138	8.8%
Abdominal distensiona bloated abdomen	135	8.6%
Anaemialow red blood cells	128	8.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	127	8.1%
Ascitesfluid in the abdomen	126	8%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	126	8%
Appendicitis	124	7.9%
Appendicolith	123	7.8%
Constipation	123	7.8%
Dry mouth	122	7.8%
Cardiogenic shockshock from the heart failing to pump	121	7.7%
Dyspnoeashortness of breath	117	7.5%
Myasthenia gravis	117	7.5%
Blood phosphorus increased	115	7.3%
Diabetes mellitusdiabetes	109	6.9%
Thrombosis	109	6.9%
Swelling	108	6.9%
Drug intolerancethe medicine was not tolerated	107	6.8%
Pulmonary embolisma blood clot in the lung	107	6.8%
Hypophosphataemia	105	6.7%
Intentional product misusedeliberate use not as intended	104	6.6%
Neuralgia	104	6.6%
Blood creatinine increasedraised creatinine, a kidney test	103	6.6%
Bacterial infectiona bacterial infection	102	6.5%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	99	6.3%
Hyperphosphataemia	96	6.1%
Incorrect route of product administrationthe product was given by the wrong route	96	6.1%
Sleep disordera sleep problem	95	6.1%
Blood cholesterol increasedraised cholesterol	94	6%
Blood uric acid increasedraised uric acid	92	5.9%
Product use in unapproved indicationused for a purpose not on the label	91	5.8%
Pruritusitching	77	4.9%
Deaththe patient died; cause not stated by this term	74	4.7%
Rashskin rash	74	4.7%
Iron deficiency	72	4.6%
Analgesic therapy	69	4.4%
Sleep disorder therapy	69	4.4%
Drug therapy	67	4.3%
Activated partial thromboplastin time prolonged	66	4.2%

Download all 259 terms of Mannitol (CSV)

The counts add to more than 1,569 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 Mannitol, 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	3	3	0	0	3	0	0	1	0
2005	12	7	0	0	6	0	0	6	5
2006	6	4	1	3	2	0	0	0	2
2007	11	9	0	0	1	3	0	8	2
2008	13	9	2	2	6	0	0	1	4
2009	11	11	9	1	8	0	0	8	0
2010	13	13	1	3	7	1	0	8	0
2011	9	9	2	3	3	1	1	4	0
2012	26	23	1	1	2	1	0	22	3
2013	24	22	5	1	5	0	0	14	2
2014	20	18	3	1	1	0	0	16	2
2015	24	24	4	3	6	2	0	13	0
2016	61	56	10	12	20	0	0	45	5
2017	41	32	8	7	11	1	0	24	9
2018	70	66	14	15	26	2	0	43	4
2019	54	47	17	5	17	1	0	31	7
2020	76	75	10	9	22	0	0	59	1
2021	86	83	11	5	22	2	0	62	3
2022	206	202	48	28	62	23	1	158	4
2023	291	288	86	70	106	58	2	242	3
2024	223	217	42	46	78	31	3	184	6
2025	181	180	49	67	99	28	19	134	1
2026	108	108	65	52	76	51	39	88	0

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 Mannitol, 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 Mannitol, by the year in which FDA received them
Year	Reports
2004	3
2005	12
2006	6
2007	11
2008	10
2009	11
2010	16
2011	9
2012	26
2013	26
2014	18
2015	24
2016	63
2017	53
2018	75
2019	51
2020	74
2021	111
2022	210
2023	291
2024	219
2025	171
2026	79

Reports that name Mannitol, 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 Mannitol
Age	Reports	Share
Under 2	13	0.8%
2 to 11	81	5.2%
12 to 17	54	3.4%
18 to 44	334	21.3%
45 to 64	394	25.1%
65 to 74	195	12.4%
75 and over	292	18.6%
Age not given	206	13.1%

Sex of the patient in the reports that name Mannitol
Sex	Reports	Share
Female	602	38.4%
Male	855	54.5%
Unknown or not given	112	7.1%

Type of reporter in the reports that name Mannitol
Reporter	Reports	Share
Physician	710	45.3%
Pharmacist	60	3.8%
Other health professional	651	41.5%
Lawyer	0	0%
Consumer or non-health professional	75	4.8%
Not given	73	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 19.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mannitol record
Indication as recorded (MedDRA)	Reports	Share
Nutritional supplementation	137	8.7%
Brain oedema	79	5%
Reduction of increased intracranial pressure	73	4.7%
Intracranial pressure increased	72	4.6%
Diuretic therapy	44	2.8%
Swelling	42	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,569 reports.

Drugs in the same reports

Other drugs that the reports of Mannitol name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	227
Allopurinol	178
Aranesp	176
Dexamethasone	168
Dextrose	201
Gabapentin	172
Melatonin	171
Metronidazole	179
Potassium chloride	186
Sodium chloride	214

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for MannitolThe 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. Mannitol: adverse event reports that FDA received. https://reportedreactions.com/drug/mannitol/ 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 Mannitol as a suspect or interacting product. The 3,287 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 Mannitol 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 Mannitol?

No. It is a count of what people reported to FDA: 1,569 reports from July 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?

Physician (45.3%), other health professional (41.5%) and consumer or non-health professional (4.8%). 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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