Ketalar (ketamine hydrochloride) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Ketamine hydrochloride
Class: General anesthetic

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 May 2026, FDA received 753 adverse event reports that name Ketalar. In these reports the drug is a suspect or interacting product.

In the same period, 260 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 23 reports in the 12 months to June 2026 and 48 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, 23 (under 0.1%) name Ketalar. Reports from consumers or other non-health professionals were 8% of the reports that name Ketalar 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 Ketalar 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 4 reports that name Ketalar.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 21.

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 89 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 729 of the 753 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 89 terms.

Reaction terms in the reports that name Ketalar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 753 reports
Drug abusemisuse of a medicine	189	25.1%
Hydronephrosis	101	13.4%
Off label useused for a purpose or in a way not on the label	101	13.4%
Cystitis	56	7.4%
Biliary tract disorder	42	5.6%
Bladder disorder	41	5.4%
Liver function test abnormal	41	5.4%
Hepatotoxicityliver injury	39	5.2%
Dilatation intrahepatic duct acquired	36	4.8%
Haematuriablood in the urine	31	4.1%
Cardiac arrestthe heart stopped	30	4%
Venoocclusive liver disease	30	4%
Biliary dilatation	25	3.3%
Deaththe patient died; cause not stated by this term	24	3.2%
Pollakiuriapassing urine more often	24	3.2%
Reduced bladder capacity	23	3.1%
Cystitis interstitial	22	2.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	21	2.8%
Drug ineffectivethe medicine did not work as expected	21	2.8%
Lower urinary tract symptoms	21	2.8%
Contracted bladder	20	2.7%
Dysuriapain on passing urine	20	2.7%
Blood alkaline phosphatase increased	18	2.4%
Accidental death	17	2.3%
Drug abuser	16	2.1%
Drug screen positive	16	2.1%
Hypotensionlow blood pressure	16	2.1%
Acute kidney injurysudden loss of kidney function	15	2%
Cholangitis sclerosing	15	2%
Drug toxicity	15	2%
Cystitis ulcerative	14	1.9%
Urge incontinence	14	1.9%
Urinary tract disorder	14	1.9%
Bronchospasmtightening of the airways	13	1.7%
Hypertonic bladder	13	1.7%
Ureteric obstruction	13	1.7%
Ureteric stenosis	13	1.7%
Bladder hypertrophy	12	1.6%
Completed suicidedeath by suicide	12	1.6%
Micturition urgency	12	1.6%
Renal impairmentreduced kidney function	12	1.6%
Biopsy bladder abnormal	11	1.5%
Drug interactionan interaction between medicines	11	1.5%
Hypersensitivityan allergic-type reaction	11	1.5%
Mania	11	1.5%
Pulmonary oedemafluid in the lungs	11	1.5%
Pyuria	10	1.3%
Ureteral disorder	10	1.3%
Ureteritis	10	1.3%
Loss of consciousnesspassing out	9	1.2%

Download all 89 terms of Ketalar (CSV)

The counts add to more than 753 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 Ketamine hydrochloride with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Ketamine hydrochloride	Generic name	1,552
Ketalar (this page)	Brand name	753

Sum of the separately reported names: 2,305. 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 Ketalar, 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	9	9	3	0	3	0	0	4	0
2005	15	14	8	1	4	0	0	6	1
2007	21	21	0	3	12	0	0	17	0
2008	8	8	0	0	7	0	0	4	0
2009	52	52	29	2	16	1	0	12	0
2010	75	75	2	14	8	0	0	66	0
2011	32	28	0	9	7	0	0	19	4
2012	28	28	0	3	7	0	0	26	0
2013	44	39	1	14	7	0	2	32	5
2014	85	76	4	11	16	0	0	70	9
2015	43	43	5	5	16	2	0	33	0
2016	52	44	6	5	14	1	0	39	8
2017	39	37	10	4	11	0	0	26	2
2018	7	7	1	4	0	0	0	3	0
2019	31	31	4	5	15	0	0	20	0
2020	31	29	10	1	15	0	0	13	2
2021	51	51	14	1	27	0	0	20	0
2022	20	19	7	2	8	0	0	9	1
2023	24	22	6	1	7	0	0	12	2
2024	27	25	2	9	13	1	0	11	2
2025	46	46	10	12	19	1	0	30	0
2026	13	12	6	0	2	0	0	7	1

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 Ketalar, 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 Ketalar, by the year in which FDA received them
Year	Reports
2004	9
2005	15
2007	23
2008	8
2009	47
2010	72
2011	39
2012	42
2013	45
2014	74
2015	43
2016	53
2017	35
2018	12
2019	25
2020	32
2021	51
2022	18
2023	25
2024	27
2025	45
2026	13

Reports that name Ketalar, 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 Ketalar
Age	Reports	Share
Under 2	7	0.9%
2 to 11	20	2.7%
12 to 17	23	3.1%
18 to 44	351	46.6%
45 to 64	89	11.8%
65 to 74	33	4.4%
75 and over	17	2.3%
Age not given	213	28.3%

Sex of the patient in the reports that name Ketalar
Sex	Reports	Share
Female	284	37.7%
Male	296	39.3%
Unknown or not given	173	23%

Type of reporter in the reports that name Ketalar
Reporter	Reports	Share
Physician	299	39.7%
Pharmacist	70	9.3%
Other health professional	290	38.5%
Lawyer	3	0.4%
Consumer or non-health professional	60	8%
Not given	31	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ketalar record
Indication as recorded (MedDRA)	Reports	Share
Drug abuse	135	17.9%
Substance use	76	10.1%
Pain	54	7.2%
Sedative therapy	36	4.8%
Anaesthesia	24	3.2%
Induction of anaesthesia	20	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 753 reports.

Pages near this one

Ketamine hydrochloride same ingredient
Isoflurane same class
Forane same class
Propofol same class
Etomidate same class
Sevoflurane same class
Kesimpta next in the A to Z list
Ketamine next in the A to Z list
Kerydin next in the A to Z list
Ketamine hcl next in the A to Z list
Kerendia next in the A to Z list
Keppra 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 KetalarThe 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. Ketalar: adverse event reports that FDA received. https://reportedreactions.com/drug/ketalar/ 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 Ketalar as a suspect or interacting product. The 260 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 Ketalar 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 Ketalar?

No. It is a count of what people reported to FDA: 753 reports from February 2004 to May 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 (39.7%), other health professional (38.5%) and pharmacist (9.3%). 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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