Etizolam adverse event reports that FDA received

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

Name type: Product name as reported

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.

Reports on file

From February 2004 to June 2026, FDA received 1,367 adverse event reports that name Etizolam. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 2,488 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 61 reports in the 12 months to June 2026 and 169 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Etizolam 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 4 reports that name Etizolam.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 17.

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 109 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 1,299 of the 1,367 reports (95%).

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 109 terms.

Reaction terms in the reports that name Etizolam, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,367 reports
Toxicity to various agentspoisoning or toxic effect of one or more substances	743	54.4%
Drug abusemisuse of a medicine	269	19.7%
Overdosea dose above the recommended amount	135	9.9%
Drug interactionan interaction between medicines	111	8.1%
Respiratory depressionslow or shallow breathing	90	6.6%
Pulmonary oedemafluid in the lungs	77	5.6%
Deaththe patient died; cause not stated by this term	58	4.2%
Falla fall	47	3.4%
Intentional overdosea deliberate overdose	45	3.3%
Depressed level of consciousness	38	2.8%
Hypotensionlow blood pressure	37	2.7%
Cardiac arrestthe heart stopped	36	2.6%
Intentional product misusedeliberate use not as intended	31	2.3%
Altered state of consciousness	30	2.2%
Dizzinesslight-headedness or unsteadiness	30	2.2%
Pulmonary congestion	30	2.2%
Somnolencedrowsiness	30	2.2%
Brain oedema	29	2.1%
Pneumonialung infection	29	2.1%
Alcohol interaction	25	1.8%
Coma	25	1.8%
Suicide attempta suicide attempt	25	1.8%
Rhabdomyolysismuscle breakdown	22	1.6%
Cardiogenic shockshock from the heart failing to pump	21	1.5%
Loss of consciousnesspassing out	21	1.5%
Accidental poisoning	20	1.5%
Pyrexiafever	19	1.4%
Completed suicidedeath by suicide	18	1.3%
Unresponsive to stimuli	18	1.3%
Withdrawal syndrome	18	1.3%
Acute kidney injurysudden loss of kidney function	17	1.2%
Deliriumsudden confusion	17	1.2%
Drug dependencedependence on a medicine	17	1.2%
Off label useused for a purpose or in a way not on the label	16	1.2%
Hepatic function abnormal	15	1.1%
Drug level above therapeutic	14	1%
Decreased appetitereduced appetite	13	1%
Drug ineffectivethe medicine did not work as expected	13	1%
Antemortem blood drug level abnormal	12	0.9%
Blood creatine phosphokinase increased	12	0.9%
Confusional stateconfusion	12	0.9%
Counterfeit drug administered	12	0.9%
Drug withdrawal syndromesymptoms on stopping a medicine	12	0.9%
Hypokalaemialow blood potassium	12	0.9%
Insomniadifficulty sleeping	12	0.9%
Postmortem blood drug level abnormal	12	0.9%
Sinus bradycardia	12	0.9%
Cardio-respiratory arrestthe heart and breathing stopped	11	0.8%
Lymphadenopathyswollen lymph nodes	11	0.8%
Septic shockshock arising from infection	11	0.8%

Download all 109 terms of Etizolam (CSV)

The counts add to more than 1,367 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 Etizolam, 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	7	7	0	1	5	0	0	1	0
2005	11	10	1	0	5	1	0	6	1
2006	8	8	4	3	6	0	0	1	0
2007	7	7	2	1	5	0	0	3	0
2008	7	7	0	1	5	0	0	4	0
2009	8	8	0	1	5	0	0	6	0
2010	9	9	2	0	5	0	0	4	0
2011	12	12	1	1	7	0	1	10	0
2012	11	11	0	0	6	0	1	7	0
2013	18	18	1	2	11	1	1	10	0
2014	25	23	4	3	12	0	0	12	2
2015	25	23	7	2	14	0	0	16	2
2016	41	41	13	4	12	1	2	27	0
2017	59	58	10	5	33	3	0	41	1
2018	41	40	11	10	24	1	0	24	1
2019	40	40	23	1	17	1	0	18	0
2020	100	100	65	8	30	0	0	66	0
2021	252	252	218	12	24	1	0	116	0
2022	235	232	185	52	62	1	2	157	3
2023	94	94	46	13	43	0	0	50	0
2024	195	194	164	5	16	1	0	65	1
2025	144	144	113	20	24	0	0	81	0
2026	18	17	3	5	7	0	0	12	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 Etizolam, 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 Etizolam, by the year in which FDA received them
Year	Reports
2004	7
2005	11
2006	7
2007	8
2008	7
2009	8
2010	10
2011	10
2012	14
2013	19
2014	27
2015	24
2016	46
2017	59
2018	39
2019	42
2020	159
2021	224
2022	234
2023	85
2024	205
2025	108
2026	14

Reports that name Etizolam, 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 Etizolam
Age	Reports	Share
Under 2	5	0.4%
2 to 11	4	0.3%
12 to 17	8	0.6%
18 to 44	660	48.3%
45 to 64	301	22%
65 to 74	56	4.1%
75 and over	119	8.7%
Age not given	214	15.7%

Sex of the patient in the reports that name Etizolam
Sex	Reports	Share
Female	421	30.8%
Male	810	59.3%
Unknown or not given	136	9.9%

Type of reporter in the reports that name Etizolam
Reporter	Reports	Share
Physician	397	29%
Pharmacist	74	5.4%
Other health professional	784	57.4%
Lawyer	1	0.1%
Consumer or non-health professional	83	6.1%
Not given	28	2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 21.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Etizolam record
Indication as recorded (MedDRA)	Reports	Share
Drug abuse	28	2%
Insomnia	27	2%
Depression	25	1.8%
Anxiety disorder	4	0.3%
Hypnotherapy	4	0.3%
Anxiety	3	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,367 reports.

Drugs in the same reports

Other drugs that the reports of Etizolam name, in any role, in order of name
Drug	Reports that name the two
Alprazolam	193
Caffeine	163
Cocaine	178
Diazepam	314
Fentanyl	371
Methadone	203
Methamphetamine	157
Mirtazapine	210
Morphine	235
Pregabalin	219

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

Ethyol next in the A to Z list
Etodolac next in the A to Z list
Ethylene Glycol next in the A to Z list
Etomidate next in the A to Z list
Ethosuximide next in the A to Z list
Etonogestrel next in the A to Z list
Ethionamide next in the A to Z list
Etonogestrel Implant- Unknown next in the A to Z list
Ethinylestradiol/Levonorgestrel next in the A to Z list
Etopophos next in the A to Z list
Ethinyl Estradiol Norethindrone Acetate next in the A to Z list
Etoposide next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for EtizolamThe 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. Etizolam: adverse event reports that FDA received. https://reportedreactions.com/drug/etizolam/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Etizolam as a suspect or interacting product. The 2,488 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 Etizolam 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 Etizolam?

No. It is a count of what people reported to FDA: 1,367 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 (57.4%), physician (29%) and consumer or non-health professional (6.1%). 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.

To the top of the page