Lasilix adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Lasilix /00032601/

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 September 2021, FDA received 3,712 adverse event reports that name Lasilix. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 7,016 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.

Reports for patients 75 and over were 50.2% of the reports that name Lasilix 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 Lasilix 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.

FDA received no report that names Lasilix 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 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 304 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 3,682 of the 3,712 reports (99.2%).

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 304 terms.

Reaction terms in the reports that name Lasilix, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,712 reports
Acute kidney injurysudden loss of kidney function	664	17.9%
Hyperkalaemiahigh blood potassium	342	9.2%
Renal failure acute	340	9.2%
Falla fall	330	8.9%
Hyponatraemialow blood sodium	319	8.6%
Renal failurekidney failure	265	7.1%
Dehydration	249	6.7%
Drug interactionan interaction between medicines	242	6.5%
Hypotensionlow blood pressure	215	5.8%
Diarrhoealoose or frequent stools	148	4%
Lactic acidosisa build-up of lactic acid in the blood	147	4%
Cardiac failureheart failure	145	3.9%
Confusional stateconfusion	132	3.6%
Hypokalaemialow blood potassium	130	3.5%
Malaisegeneral feeling of being unwell	129	3.5%
General physical health deteriorationgeneral decline in health	126	3.4%
Bradycardiaslow heart rate	113	3%
Vomitingbeing sick	106	2.9%
Anaemialow red blood cells	97	2.6%
Thrombocytopenialow platelets	96	2.6%
Eosinophilia	93	2.5%
Pyrexiafever	93	2.5%
Orthostatic hypotension	82	2.2%
Condition aggravatedthe condition being treated got worse	81	2.2%
Blood creatinine increasedraised creatinine, a kidney test	80	2.2%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	76	2%
Pruritusitching	73	2%
International normalised ratio increasedblood clotting slower than intended (raised INR)	70	1.9%
Cardio-respiratory arrestthe heart and breathing stopped	67	1.8%
Oedema peripheralswelling of the legs, ankles or hands	67	1.8%
Overdosea dose above the recommended amount	67	1.8%
Hypoglycaemialow blood sugar	63	1.7%
Haematomaa collection of blood under the skin or in tissue	61	1.6%
Cholestasis	60	1.6%
Rashskin rash	60	1.6%
Rhabdomyolysismuscle breakdown	58	1.6%
Astheniaweakness or lack of energy	57	1.5%
Coma	56	1.5%
Agranulocytosis	55	1.5%
Dyspnoeashortness of breath	55	1.5%
Rash maculo-papulara rash of flat and raised spots	55	1.5%
Loss of consciousnesspassing out	53	1.4%
Somnolencedrowsiness	52	1.4%
Atrial fibrillationan irregular heart rhythm	51	1.4%
Off label useused for a purpose or in a way not on the label	51	1.4%
Pancytopenialow counts of all blood cells	51	1.4%
Metabolic acidosistoo much acid in the body fluids	47	1.3%
Septic shockshock arising from infection	47	1.3%
Toxic skin eruption	47	1.3%
Hepatic failureliver failure	46	1.2%

Download all 304 terms of Lasilix (CSV)

The counts add to more than 3,712 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 Lasilix, 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	74	74	11	4	68	0	0	3	0
2005	150	150	30	11	133	0	0	3	0
2006	147	147	17	6	125	2	4	6	0
2007	76	76	11	11	60	2	1	3	0
2008	120	120	18	13	109	0	0	10	0
2009	116	116	28	11	93	1	0	16	0
2010	40	40	9	6	29	1	0	2	0
2011	7	7	1	0	6	0	0	0	0
2012	102	102	14	22	84	3	0	25	0
2013	349	348	90	40	265	3	0	68	1
2014	325	325	38	29	263	8	0	83	0
2015	385	385	60	29	332	3	2	74	0
2016	371	370	43	48	301	1	6	99	1
2017	210	210	38	14	164	5	0	76	0
2018	373	373	30	36	271	5	0	140	0
2019	453	453	61	30	321	6	0	179	0
2020	324	324	21	39	207	4	0	135	0
2021	90	90	34	5	34	4	0	57	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 Lasilix, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Lasilix, by the year in which FDA received them
Year	Reports
2004	60
2005	144
2006	164
2007	77
2008	123
2009	116
2010	51
2011	11
2012	154
2013	351
2014	313
2015	406
2016	359
2017	209
2018	386
2019	411
2020	309
2021	67

Reports that name Lasilix, 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 Lasilix
Age	Reports	Share
Under 2	27	0.7%
2 to 11	20	0.5%
12 to 17	9	0.2%
18 to 44	117	3.2%
45 to 64	578	15.6%
65 to 74	788	21.2%
75 and over	1,862	50.2%
Age not given	311	8.4%

Sex of the patient in the reports that name Lasilix
Sex	Reports	Share
Female	1,894	51%
Male	1,629	43.9%
Unknown or not given	189	5.1%

Type of reporter in the reports that name Lasilix
Reporter	Reports	Share
Physician	809	21.8%
Pharmacist	298	8%
Other health professional	1,907	51.4%
Lawyer	0	0%
Consumer or non-health professional	318	8.6%
Not given	380	10.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lasilix record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	794	21.4%
Cardiac failure	252	6.8%
Oedema	75	2%
Oedema peripheral	68	1.8%
Essential hypertension	32	0.9%
Acute pulmonary oedema	28	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,712 reports.

Drugs in the same reports

Other drugs that the reports of Lasilix name, in any role, in order of name
Drug	Reports that name the two
Aldactone	377
Allopurinol	205
Bisoprolol	219
Cordarone	350
Diffu K	366
Kardegic	568
Levothyrox	282
Pantoprazole	179
Ramipril	189
Tahor	314

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

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for LasilixThe 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. Lasilix: adverse event reports that FDA received. https://reportedreactions.com/drug/lasilix/ 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 Lasilix as a suspect or interacting product. The 7,016 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 Lasilix 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 Lasilix?

No. It is a count of what people reported to FDA: 3,712 reports from January 2004 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 (51.4%), physician (21.8%) and consumer or non-health professional (8.6%). 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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