Lormetazepam adverse event reports that FDA received

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

Name type: Generic name

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 June 2026, FDA received 2,905 adverse event reports that name Lormetazepam. In these reports the drug is a suspect or interacting product.

In the same period, 3,332 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 351 reports in the 12 months to June 2026 and 299 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, 351 (under 0.1%) name Lormetazepam. Reports from consumers or other non-health professionals were 6.5% of the reports that name Lormetazepam 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 Lormetazepam 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 110 reports that name Lormetazepam.
In January to March 2026, FDA received 66.
In April to June 2025, FDA received 70.

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 373 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 2,858 of the 2,905 reports (98.4%).

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 373 terms.

Reaction terms in the reports that name Lormetazepam, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,905 reports
Coma	424	14.6%
Drug abusemisuse of a medicine	423	14.6%
Somnolencedrowsiness	306	10.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	296	10.2%
Poisoning deliberate	228	7.8%
Intentional overdosea deliberate overdose	204	7%
Falla fall	193	6.6%
Drug interactionan interaction between medicines	191	6.6%
Drug use disorder	173	6%
Drug dependencedependence on a medicine	147	5.1%
Depressed level of consciousness	134	4.6%
Overdosea dose above the recommended amount	134	4.6%
Suicide attempta suicide attempt	132	4.5%
Confusional stateconfusion	126	4.3%
Hypotensionlow blood pressure	110	3.8%
Miosis	103	3.5%
Intentional product misusedeliberate use not as intended	102	3.5%
Sopor	99	3.4%
Acute kidney injurysudden loss of kidney function	93	3.2%
Substance use disorder	84	2.9%
Altered state of consciousness	81	2.8%
Poisoning	75	2.6%
Insomniadifficulty sleeping	70	2.4%
Headachehead pain	68	2.3%
Renal failurekidney failure	68	2.3%
Loss of consciousnesspassing out	66	2.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	64	2.2%
Cardio-respiratory arrestthe heart and breathing stopped	61	2.1%
Off label useused for a purpose or in a way not on the label	59	2%
Asphyxia	56	1.9%
Drug ineffectivethe medicine did not work as expected	52	1.8%
Intentional self-injury	52	1.8%
Treatment noncompliancethe treatment was not taken as directed	50	1.7%
Bradycardiaslow heart rate	48	1.7%
Hyperglycaemiahigh blood sugar	48	1.7%
Hypertensionhigh blood pressure	48	1.7%
Balance disorderproblems with balance	46	1.6%
Cognitive disorderproblems with thinking or memory	46	1.6%
Hypoglycaemialow blood sugar	46	1.6%
Pneumonia aspirationlung infection from breathing in material	46	1.6%
Depressionlow mood	43	1.5%
Respiratory acidosis	42	1.4%
Rhabdomyolysismuscle breakdown	42	1.4%
Hypokalaemialow blood potassium	41	1.4%
Respiratory depressionslow or shallow breathing	41	1.4%
Tachycardiafast heart rate	41	1.4%
Lactic acidosisa build-up of lactic acid in the blood	39	1.3%
Tremorshaking	38	1.3%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	37	1.3%
Vomitingbeing sick	36	1.2%

Download all 373 terms of Lormetazepam (CSV)

The counts add to more than 2,905 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 Lormetazepam, 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	4	4	0	3	1	0	0	2	0
2005	6	6	0	0	5	0	0	2	0
2006	8	8	2	1	3	0	0	3	0
2007	8	8	0	3	7	0	0	2	0
2008	11	11	0	1	6	0	1	4	0
2009	14	14	4	0	6	0	0	4	0
2010	13	13	0	1	12	0	0	2	0
2011	10	9	1	1	6	0	0	3	1
2012	29	29	1	3	24	0	2	7	0
2013	36	36	2	0	21	0	0	15	0
2014	35	34	4	0	23	0	0	10	1
2015	44	44	1	2	30	0	3	14	0
2016	37	37	3	8	22	0	1	17	0
2017	76	76	1	14	45	0	0	37	0
2018	221	221	13	49	143	1	1	111	0
2019	343	339	54	23	216	1	2	112	4
2020	310	307	59	78	171	0	0	116	3
2021	205	205	26	23	112	8	16	100	0
2022	268	267	32	60	141	10	0	135	1
2023	343	342	34	103	175	0	0	195	1
2024	346	344	69	82	151	0	0	207	2
2025	337	336	66	101	215	0	1	180	1
2026	201	201	25	38	85	12	1	110	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 Lormetazepam, 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 Lormetazepam, by the year in which FDA received them
Year	Reports
2004	4
2005	7
2006	6
2007	10
2008	11
2009	16
2010	12
2011	11
2012	32
2013	34
2014	44
2015	44
2016	55
2017	109
2018	223
2019	390
2020	309
2021	219
2022	248
2023	327
2024	302
2025	316
2026	176

Reports that name Lormetazepam, 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 Lormetazepam
Age	Reports	Share
Under 2	27	0.9%
2 to 11	4	0.1%
12 to 17	33	1.1%
18 to 44	795	27.4%
45 to 64	877	30.2%
65 to 74	348	12%
75 and over	403	13.9%
Age not given	418	14.4%

Sex of the patient in the reports that name Lormetazepam
Sex	Reports	Share
Female	1,562	53.8%
Male	1,063	36.6%
Unknown or not given	280	9.6%

Type of reporter in the reports that name Lormetazepam
Reporter	Reports	Share
Physician	1,217	41.9%
Pharmacist	776	26.7%
Other health professional	703	24.2%
Lawyer	0	0%
Consumer or non-health professional	188	6.5%
Not given	21	0.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lormetazepam record
Indication as recorded (MedDRA)	Reports	Share
Insomnia	262	9%
Anxiety	118	4.1%
Sleep disorder	87	3%
Depression	77	2.7%
Suicide attempt	74	2.5%
Poisoning deliberate	69	2.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,905 reports.

Drugs in the same reports

Other drugs that the reports of Lormetazepam name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	255
Alprazolam	442
Diazepam	538
Lorazepam	372
Mirtazapine	201
Olanzapine	261
Oxazepam	329
Quetiapine	391
Tramadol	216
Venlafaxine	251

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 LormetazepamThe 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. Lormetazepam: adverse event reports that FDA received. https://reportedreactions.com/drug/lormetazepam/ 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 Lormetazepam as a suspect or interacting product. The 3,332 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 Lormetazepam 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 Lormetazepam?

No. It is a count of what people reported to FDA: 2,905 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?

Physician (41.9%), pharmacist (26.7%) and other health professional (24.2%). 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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