Delorazepam adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Delorazepam Oral Drops Solution, Delorazepam Tablet

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 June 2007 to May 2026, FDA received 1,270 adverse event reports that name Delorazepam. In these reports the drug is a suspect or interacting product.

In the same period, 812 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 31 reports in the 12 months to June 2026 and 49 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 Delorazepam 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 7 reports that name Delorazepam.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 18.

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 127 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 1,244 of the 1,270 reports (98%).

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 127 terms.

Reaction terms in the reports that name Delorazepam, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,270 reports
Drug abusemisuse of a medicine	552	43.5%
Sopor	409	32.2%
Intentional self-injury	272	21.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	153	12%
Suicide attempta suicide attempt	129	10.2%
Intentional overdosea deliberate overdose	100	7.9%
Overdosea dose above the recommended amount	84	6.6%
Intentional product misusedeliberate use not as intended	67	5.3%
Coma	66	5.2%
Confusional stateconfusion	66	5.2%
Hypotensionlow blood pressure	65	5.1%
Somnolencedrowsiness	58	4.6%
Drug interactionan interaction between medicines	56	4.4%
Bradyphrenia	46	3.6%
Loss of consciousnesspassing out	43	3.4%
Tachycardiafast heart rate	37	2.9%
Electrocardiogram QT prolongeda QT prolongation on the ECG	33	2.6%
Respiratory depressionslow or shallow breathing	30	2.4%
Speech disordera speech problem	30	2.4%
Agitationrestlessness	29	2.3%
Drug ineffectivethe medicine did not work as expected	29	2.3%
Depressed level of consciousness	27	2.1%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	27	2.1%
Poisoning	26	2%
Psychomotor hyperactivity	26	2%
Self injurious behaviour	26	2%
Anxiety	25	2%
Completed suicidedeath by suicide	25	2%
Bradykinesia	24	1.9%
Mydriasis	24	1.9%
Sluggishness	24	1.9%
Blood creatine phosphokinase increased	23	1.8%
Dysarthria	23	1.8%
Aggressionaggressive behaviour	22	1.7%
Substance abuse	22	1.7%
Psychomotor retardation	21	1.7%
Disorientation	20	1.6%
Product use in unapproved indicationused for a purpose not on the label	20	1.6%
Sedationdrowsiness	18	1.4%
Off label useused for a purpose or in a way not on the label	17	1.3%
Respiratory failurethe lungs could not supply enough oxygen	17	1.3%
Rhabdomyolysismuscle breakdown	17	1.3%
Asphyxia	15	1.2%
Confabulation	15	1.2%
Eyelid oedemaa swollen eyelid	15	1.2%
Mood altereda change in mood	15	1.2%
Headachehead pain	14	1.1%
Hypokalaemialow blood potassium	13	1%
Hyporesponsive to stimuli	13	1%
Movement disorder	13	1%

Download all 127 terms of Delorazepam (CSV)

The counts add to more than 1,270 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 Delorazepam, 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
2005	0	0	0	0	0	0	0	0	0
2007	1	1	0	0	1	0	0	0	0
2009	3	3	0	0	1	1	0	2	0
2010	6	6	1	1	3	0	0	3	0
2011	12	12	0	0	10	0	0	3	0
2012	27	27	0	0	17	0	0	10	0
2013	63	63	0	1	35	0	0	32	0
2014	135	134	4	10	78	0	0	54	1
2015	53	53	0	0	30	0	0	26	0
2016	68	68	11	0	40	0	2	28	0
2017	58	58	2	2	42	0	0	24	0
2018	182	182	28	28	92	0	0	96	0
2019	139	139	6	10	65	0	0	84	0
2020	118	118	12	0	88	0	0	49	0
2021	89	89	14	14	40	0	0	40	0
2022	121	121	32	18	53	0	0	69	0
2023	70	70	1	10	47	0	0	42	0
2024	39	38	3	5	24	0	0	25	1
2025	69	65	5	22	42	0	0	57	4
2026	17	17	1	12	5	0	0	10	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 Delorazepam, 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 Delorazepam, by the year in which FDA received them
Year	Reports
2007	1
2009	3
2010	6
2011	11
2012	29
2013	68
2014	138
2015	56
2016	67
2017	88
2018	160
2019	137
2020	125
2021	94
2022	117
2023	64
2024	35
2025	54
2026	17

Reports that name Delorazepam, 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 Delorazepam
Age	Reports	Share
Under 2	2	0.2%
2 to 11	3	0.2%
12 to 17	30	2.4%
18 to 44	574	45.2%
45 to 64	361	28.4%
65 to 74	83	6.5%
75 and over	68	5.4%
Age not given	149	11.7%

Sex of the patient in the reports that name Delorazepam
Sex	Reports	Share
Female	703	55.4%
Male	480	37.8%
Unknown or not given	87	6.9%

Type of reporter in the reports that name Delorazepam
Reporter	Reports	Share
Physician	527	41.5%
Pharmacist	164	12.9%
Other health professional	428	33.7%
Lawyer	0	0%
Consumer or non-health professional	136	10.7%
Not given	15	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Delorazepam record
Indication as recorded (MedDRA)	Reports	Share
Anxiety	88	6.9%
Drug abuse	71	5.6%
Intentional self-injury	69	5.4%
Depression	44	3.5%
Suicide attempt	31	2.4%
Personality disorder	20	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,270 reports.

Drugs in the same reports

Other drugs that the reports of Delorazepam name, in any role, in order of name
Drug	Reports that name the two
Alprazolam	110
Aripiprazole	66
Citalopram	76
Lorazepam	145
Mirtazapine	71
Olanzapine	144
Paroxetine	102
Pregabalin	77
Quetiapine	140
Sertraline	115

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for DelorazepamThe 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. Delorazepam: adverse event reports that FDA received. https://reportedreactions.com/drug/delorazepam/ 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 Delorazepam as a suspect or interacting product. The 812 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 Delorazepam 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 Delorazepam?

No. It is a count of what people reported to FDA: 1,270 reports from June 2007 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 (41.5%), other health professional (33.7%) and pharmacist (12.9%). 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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