Midazolam hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Benzodiazepine
Also reported as: Midazolam Hydrochloride Injection, Midazolam Hydrochloride 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 January 2004 to June 2026, FDA received 1,731 adverse event reports that name Midazolam hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 1,171 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 125 reports in the 12 months to June 2026 and 126 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, 125 (under 0.1%) name Midazolam hydrochloride. Reports from consumers or other non-health professionals were 10.3% of the reports that name Midazolam hydrochloride 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 Midazolam hydrochloride 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 41 reports that name Midazolam hydrochloride.
In January to March 2026, FDA received 17.
In April to June 2025, FDA received 30.

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 320 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 1,686 of the 1,731 reports (97.4%).

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 320 terms.

Reaction terms in the reports that name Midazolam hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,731 reports
Drug ineffectivethe medicine did not work as expected	291	16.8%
Off label useused for a purpose or in a way not on the label	189	10.9%
Hypotensionlow blood pressure	177	10.2%
Pyrexiafever	115	6.6%
Drug interactionan interaction between medicines	91	5.3%
Nauseafeeling sick	91	5.3%
Colitisinflamed bowel	85	4.9%
Constipation	85	4.9%
Abdominal painstomach or belly pain	82	4.7%
Headachehead pain	82	4.7%
Seizurea fit or convulsion	82	4.7%
Anaemialow red blood cells	81	4.7%
Painpain, site not specified	78	4.5%
Erythemaskin redness	77	4.4%
Frequent bowel movements	77	4.4%
Colitis ulcerative	76	4.4%
Haematocheziablood in the stool	72	4.2%
Female genital tract fistula	71	4.1%
Proctitis	70	4%
Oral candidiasisoral thrush	68	3.9%
Radiculopathy	65	3.8%
Vaginal flatulence	65	3.8%
Rectal haemorrhage	63	3.6%
Product use in unapproved indicationused for a purpose not on the label	62	3.6%
Somnolencedrowsiness	62	3.6%
Vaginal discharge	62	3.6%
Toxicity to various agentspoisoning or toxic effect of one or more substances	61	3.5%
Malaisegeneral feeling of being unwell	59	3.4%
Cardiac arrestthe heart stopped	58	3.4%
Oxygen saturation decreased	57	3.3%
Therapeutic product effect incomplete	57	3.3%
Condition aggravatedthe condition being treated got worse	54	3.1%
Tachycardiafast heart rate	51	2.9%
Troponin increased	50	2.9%
Respiratory failurethe lungs could not supply enough oxygen	49	2.8%
Weight decreasedweight loss	49	2.8%
Hypoxialow oxygen	48	2.8%
Dyspnoeashortness of breath	45	2.6%
Blood creatine phosphokinase increased	44	2.5%
Vomitingbeing sick	44	2.5%
Alanine aminotransferase increasedraised liver enzyme (ALT)	43	2.5%
Bradycardiaslow heart rate	43	2.5%
Confusional stateconfusion	43	2.5%
Respiratory depressionslow or shallow breathing	43	2.5%
Paraesthesia oral	42	2.4%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	42	2.4%
Rash maculo-papulara rash of flat and raised spots	41	2.4%
Agitationrestlessness	39	2.3%
Chronic sinusitis	39	2.3%
Dizzinesslight-headedness or unsteadiness	38	2.2%

Download all 320 terms of Midazolam hydrochloride (CSV)

The counts add to more than 1,731 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 Midazolam with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Midazolam	Generic name	11,299
Midazolam hydrochloride (this page)	Generic name	1,731
Nayzilam	Brand name	517

Sum of the separately reported names: 13,547. 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 Midazolam hydrochloride, 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	24	7	0	3	3	0	0	1	17
2005	20	14	1	3	9	2	0	3	6
2006	53	46	5	9	23	1	0	16	7
2007	33	23	3	3	9	0	0	14	10
2008	27	24	4	6	10	0	1	12	3
2009	44	42	9	6	14	6	0	23	2
2010	24	24	5	4	8	0	0	10	0
2011	23	22	6	2	11	0	0	8	1
2012	19	17	3	1	8	0	0	10	2
2013	14	14	4	1	9	1	0	5	0
2014	7	7	2	0	3	0	0	4	0
2015	27	22	2	5	8	1	0	19	5
2016	38	28	4	2	6	0	0	22	10
2017	35	27	7	6	15	0	1	17	8
2018	95	60	11	15	23	0	0	43	35
2019	80	78	11	6	23	0	2	55	2
2020	301	267	61	76	129	2	5	163	34
2021	85	81	16	8	21	0	1	66	4
2022	153	142	31	16	57	1	0	107	11
2023	163	152	39	42	81	5	4	110	11
2024	193	174	18	41	90	1	1	132	19
2025	174	167	23	34	88	4	2	129	7
2026	99	95	29	15	41	0	0	80	4

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 Midazolam hydrochloride, 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 Midazolam hydrochloride, by the year in which FDA received them
Year	Reports
2004	22
2005	21
2006	53
2007	31
2008	29
2009	47
2010	24
2011	25
2012	23
2013	9
2014	8
2015	28
2016	41
2017	50
2018	114
2019	110
2020	284
2021	120
2022	167
2023	165
2024	174
2025	128
2026	58

Reports that name Midazolam hydrochloride, 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 Midazolam hydrochloride
Age	Reports	Share
Under 2	69	4%
2 to 11	109	6.3%
12 to 17	62	3.6%
18 to 44	337	19.5%
45 to 64	380	22%
65 to 74	203	11.7%
75 and over	128	7.4%
Age not given	443	25.6%

Sex of the patient in the reports that name Midazolam hydrochloride
Sex	Reports	Share
Female	734	42.4%
Male	741	42.8%
Unknown or not given	256	14.8%

Type of reporter in the reports that name Midazolam hydrochloride
Reporter	Reports	Share
Physician	512	29.6%
Pharmacist	150	8.7%
Other health professional	823	47.5%
Lawyer	2	0.1%
Consumer or non-health professional	179	10.3%
Not given	65	3.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Midazolam hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Sedation	257	14.8%
Seizure	141	8.1%
Anaesthesia	116	6.7%
Status epilepticus	106	6.1%
Sedative therapy	98	5.7%
Induction of anaesthesia	26	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,731 reports.

Drugs in the same reports

Other drugs that the reports of Midazolam hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	159
Diazepam	212
Fentanyl	399
Furosemide	113
Levetiracetam	193
Lorazepam	149
Morphine	124
Phenobarbital	120
Phenytoin	106
Propofol	524

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

Midazolam same ingredient
Nayzilam same ingredient
Lorazepam same class
Onfi same class
Klonopin same class
Oxazepam same class
Midazolam hcl next in the A to Z list
Midodrine next in the A to Z list
Midodrine hydrochloride next in the A to Z list
Micronor next in the A to Z list
Midol next in the A to Z list
Miconazole nitrate 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 Midazolam hydrochlorideThe 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. Midazolam hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/midazolam-hydrochloride/ 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 Midazolam hydrochloride as a suspect or interacting product. The 1,171 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 Midazolam hydrochloride 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 Midazolam hydrochloride?

No. It is a count of what people reported to FDA: 1,731 reports from January 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 (47.5%), physician (29.6%) and consumer or non-health professional (10.3%). 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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