Bumetanide adverse event reports that FDA received

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

Name type: Generic name
Class: Loop diuretic
Also reported as: Bumetanide Tablets Usp, Bumetanide Tab

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 February 2004 to June 2026, FDA received 2,140 adverse event reports that name Bumetanide. In these reports the drug is a suspect or interacting product.

In the same period, 17,925 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 121 reports in the 12 months to June 2026 and 153 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, 121 (under 0.1%) name Bumetanide. Reports from consumers or other non-health professionals were 18.8% of the reports that name Bumetanide 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 Bumetanide 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 30 reports that name Bumetanide.
In January to March 2026, FDA received 27.
In April to June 2025, FDA received 40.

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 268 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 2,120 of the 2,140 reports (99.1%).

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 268 terms.

Reaction terms in the reports that name Bumetanide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,140 reports
Acute kidney injurysudden loss of kidney function	448	20.9%
Drug ineffectivethe medicine did not work as expected	171	8%
Hypotensionlow blood pressure	159	7.4%
Dehydration	141	6.6%
Fatiguetiredness	141	6.6%
Dyspnoeashortness of breath	121	5.7%
Dizzinesslight-headedness or unsteadiness	109	5.1%
Renal failure acute	86	4%
Weight increasedweight gain	86	4%
Cardiac failureheart failure	85	4%
Renal impairmentreduced kidney function	80	3.7%
Hyperkalaemiahigh blood potassium	79	3.7%
Completed suicidedeath by suicide	77	3.6%
Hyponatraemialow blood sodium	77	3.6%
Hypokalaemialow blood potassium	73	3.4%
Drug interactionan interaction between medicines	72	3.4%
Renal failurekidney failure	72	3.4%
Poor quality sleep	68	3.2%
Insomniadifficulty sleeping	66	3.1%
Diarrhoealoose or frequent stools	65	3%
Falla fall	65	3%
Pneumonialung infection	65	3%
Atrial fibrillationan irregular heart rhythm	64	3%
Hypertensionhigh blood pressure	64	3%
Condition aggravatedthe condition being treated got worse	62	2.9%
Astheniaweakness or lack of energy	60	2.8%
Impaired quality of life	59	2.8%
Bradycardiaslow heart rate	58	2.7%
Impaired work abilityreduced ability to work	58	2.7%
Cellulitisa skin infection	56	2.6%
Hyperlipidaemiaraised blood fats	54	2.5%
Malaisegeneral feeling of being unwell	54	2.5%
Blood creatinine increasedraised creatinine, a kidney test	52	2.4%
Confusional stateconfusion	52	2.4%
Contusiona bruise	52	2.4%
Nauseafeeling sick	52	2.4%
Body tinea	51	2.4%
Bone density decreased	51	2.4%
Cataractclouding of the eye lens	51	2.4%
Glucose tolerance impaired	51	2.4%
Herpes zostershingles	51	2.4%
Infection susceptibility increased	51	2.4%
Off label useused for a purpose or in a way not on the label	51	2.4%
Oral herpesa cold sore	51	2.4%
Purpura	51	2.4%
Skin disorder	51	2.4%
Inhibitory drug interaction	50	2.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	49	2.3%
Rash maculo-papulara rash of flat and raised spots	48	2.2%
Thrombocytopenialow platelets	43	2%

Download all 268 terms of Bumetanide (CSV)

The counts add to more than 2,140 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 Bumetanide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Bumetanide (this page)	Generic name	2,140
Bumex	Brand name	511

Sum of the separately reported names: 2,651. 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 Bumetanide, 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	16	15	6	1	11	0	1	3	1
2005	46	45	12	5	30	0	0	8	1
2006	42	38	10	0	30	0	0	11	4
2007	40	31	4	3	19	5	0	9	9
2008	27	26	4	1	17	1	0	7	1
2009	23	19	7	0	7	0	0	6	4
2010	26	25	2	9	18	1	0	9	1
2011	41	40	9	1	23	0	0	12	1
2012	57	55	18	3	31	2	0	17	2
2013	51	47	8	2	29	1	0	12	4
2014	80	79	18	1	58	0	0	24	1
2015	98	88	6	3	58	0	0	31	10
2016	98	82	6	6	73	2	0	18	16
2017	95	77	7	7	64	2	0	27	18
2018	129	73	4	3	50	4	0	29	56
2019	139	129	23	12	89	14	0	73	10
2020	222	203	46	28	131	14	0	124	19
2021	112	99	14	2	45	0	0	73	13
2022	165	153	28	12	94	2	0	103	12
2023	192	171	15	5	130	1	0	117	21
2024	214	184	37	10	137	5	0	134	30
2025	144	128	9	10	85	1	0	90	16
2026	83	68	6	3	43	0	0	51	15

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 Bumetanide, 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 Bumetanide, by the year in which FDA received them
Year	Reports
2004	14
2005	42
2006	45
2007	41
2008	30
2009	23
2010	27
2011	40
2012	67
2013	52
2014	80
2015	100
2016	106
2017	105
2018	134
2019	156
2020	223
2021	136
2022	150
2023	202
2024	187
2025	123
2026	57

Reports that name Bumetanide, 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 Bumetanide
Age	Reports	Share
Under 2	5	0.2%
2 to 11	12	0.6%
12 to 17	6	0.3%
18 to 44	75	3.5%
45 to 64	465	21.7%
65 to 74	329	15.4%
75 and over	730	34.1%
Age not given	518	24.2%

Sex of the patient in the reports that name Bumetanide
Sex	Reports	Share
Female	859	40.1%
Male	955	44.6%
Unknown or not given	326	15.2%

Type of reporter in the reports that name Bumetanide
Reporter	Reports	Share
Physician	479	22.4%
Pharmacist	481	22.5%
Other health professional	708	33.1%
Lawyer	0	0%
Consumer or non-health professional	402	18.8%
Not given	70	3.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 42.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Bumetanide record
Indication as recorded (MedDRA)	Reports	Share
Cardiac failure	187	8.7%
Cardiac failure congestive	103	4.8%
Hypertension	97	4.5%
Complex regional pain syndrome	69	3.2%
Diuretic therapy	41	1.9%
Oedema	39	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,140 reports.

Drugs in the same reports

Other drugs that the reports of Bumetanide name, in any role, in order of name
Drug	Reports that name the two
Atorvastatin	280
Bisoprolol	371
Carvedilol	162
Furosemide	234
Lansoprazole	159
Lisinopril	148
Metformin	153
Ramipril	201
Simvastatin	157
Spironolactone	601

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

Bumex same ingredient
Furoscix same class
Furosemide same class
Bufferin next in the A to Z list
Budesonide Formoterol Glycopyrronium next in the A to Z list
Buphenyl next in the A to Z list
Budesonide Formoterol Fumarate Dihydrate next in the A to Z list
Bupivacaine next in the A to Z list
Budesonide Formoterol Fumarate next in the A to Z list
Bupivacaine hcl next in the A to Z list
Budesonide Formoterol next in the A to Z list
Bupivacaine hydrochloride 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 BumetanideThe 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. Bumetanide: adverse event reports that FDA received. https://reportedreactions.com/drug/bumetanide/ 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 Bumetanide as a suspect or interacting product. The 17,925 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 Bumetanide 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 Bumetanide?

No. It is a count of what people reported to FDA: 2,140 reports from February 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 (33.1%), pharmacist (22.5%) and physician (22.4%). 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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