Imovane adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Imovane
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.

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 2,986 adverse event reports that name Imovane. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 7,822 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 27 reports in the 12 months to June 2026 and 94 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, 27 (under 0.1%) name Imovane. Reports from consumers or other non-health professionals were 14.6% of the reports that name Imovane 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 Imovane 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 3 reports that name Imovane.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 16.

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 411 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 all 2,986 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 411 terms.

Reaction terms in the reports that name Imovane, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,986 reports
Intentional overdosea deliberate overdose	417	14%
Intentional self-injury	331	11.1%
Falla fall	275	9.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	251	8.4%
Somnolencedrowsiness	219	7.3%
Coma	200	6.7%
Confusional stateconfusion	163	5.5%
Fatiguetiredness	154	5.2%
Hypotensionlow blood pressure	133	4.5%
Suicide attempta suicide attempt	126	4.2%
Depressed level of consciousness	115	3.9%
Overdosea dose above the recommended amount	115	3.9%
Loss of consciousnesspassing out	109	3.7%
Malaisegeneral feeling of being unwell	107	3.6%
Poisoning deliberate	97	3.2%
Anxiety	88	2.9%
Drug abusemisuse of a medicine	87	2.9%
Drug interactionan interaction between medicines	83	2.8%
Dyspnoeashortness of breath	82	2.7%
Agitationrestlessness	81	2.7%
Drug dependencedependence on a medicine	81	2.7%
Suicidal ideationthoughts of suicide	76	2.5%
Hepatocellular injury	75	2.5%
Condition aggravatedthe condition being treated got worse	69	2.3%
Pneumonia aspirationlung infection from breathing in material	69	2.3%
Insomniadifficulty sleeping	67	2.2%
Tachycardiafast heart rate	66	2.2%
Tremorshaking	66	2.2%
Cholestasis	63	2.1%
Disturbance in attentiondifficulty concentrating	60	2%
Pyrexiafever	60	2%
Balance disorderproblems with balance	59	2%
Vomitingbeing sick	59	2%
Altered state of consciousness	56	1.9%
Bradycardiaslow heart rate	54	1.8%
Hyponatraemialow blood sodium	53	1.8%
Weight decreasedweight loss	53	1.8%
Drug ineffectivethe medicine did not work as expected	51	1.7%
Nauseafeeling sick	51	1.7%
Off label useused for a purpose or in a way not on the label	51	1.7%
Rhabdomyolysismuscle breakdown	51	1.7%
Pruritusitching	50	1.7%
Acute kidney injurysudden loss of kidney function	49	1.6%
Completed suicidedeath by suicide	48	1.6%
Palpitationsawareness of the heartbeat	47	1.6%
Astheniaweakness or lack of energy	46	1.5%
Miosis	46	1.5%
Painpain, site not specified	46	1.5%
Product use in unapproved indicationused for a purpose not on the label	45	1.5%
Thrombocytopenialow platelets	45	1.5%

Download all 411 terms of Imovane (CSV)

The counts add to more than 2,986 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 Imovane, 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	35	35	0	2	33	0	0	6	0
2005	51	50	5	2	40	2	2	10	1
2006	47	47	2	8	38	1	0	10	0
2007	43	43	9	7	34	3	0	5	0
2008	55	55	13	7	45	4	0	8	0
2009	48	48	11	6	36	1	0	12	0
2010	91	91	9	7	64	2	1	23	0
2011	71	71	3	6	59	0	2	14	0
2012	99	99	20	8	70	0	0	34	0
2013	109	109	19	18	71	0	0	48	0
2014	142	142	17	22	96	1	3	65	0
2015	139	139	8	13	119	3	5	36	0
2016	159	159	11	16	124	2	4	68	0
2017	172	172	13	8	124	4	3	77	0
2018	354	354	39	66	233	5	3	131	0
2019	433	433	23	64	304	3	4	145	0
2020	384	384	5	41	276	13	0	129	0
2021	167	167	21	24	99	6	0	69	0
2022	142	142	10	8	95	1	0	75	0
2023	65	65	1	4	44	0	5	43	0
2024	77	77	6	19	40	0	8	49	0
2025	87	87	2	26	48	0	0	49	0
2026	16	16	0	8	12	0	0	13	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 Imovane, 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 Imovane, by the year in which FDA received them
Year	Reports
2004	34
2005	46
2006	50
2007	46
2008	56
2009	48
2010	85
2011	92
2012	118
2013	120
2014	140
2015	143
2016	159
2017	183
2018	359
2019	445
2020	394
2021	141
2022	121
2023	61
2024	75
2025	64
2026	6

Reports that name Imovane, 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 Imovane
Age	Reports	Share
Under 2	38	1.3%
2 to 11	7	0.2%
12 to 17	28	0.9%
18 to 44	724	24.2%
45 to 64	662	22.2%
65 to 74	365	12.2%
75 and over	621	20.8%
Age not given	541	18.1%

Sex of the patient in the reports that name Imovane
Sex	Reports	Share
Female	1,814	60.8%
Male	1,003	33.6%
Unknown or not given	169	5.7%

Type of reporter in the reports that name Imovane
Reporter	Reports	Share
Physician	983	32.9%
Pharmacist	267	8.9%
Other health professional	1,206	40.4%
Lawyer	4	0.1%
Consumer or non-health professional	437	14.6%
Not given	89	3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Imovane record
Indication as recorded (MedDRA)	Reports	Share
Insomnia	550	18.4%
Sleep disorder	146	4.9%
Depression	57	1.9%
Intentional overdose	32	1.1%
Anxiety	20	0.7%
Suicide attempt	17	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,986 reports.

Drugs in the same reports

Other drugs that the reports of Imovane name, in any role, in order of name
Drug	Reports that name the two
Abilify	147
Alprazolam	142
Atarax	176
Kardegic	232
Lyrica	193
Paracetamol	140
Quetiapine	159
Seresta	251
Valium	201
Xanax	184

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 ImovaneThe 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. Imovane: adverse event reports that FDA received. https://reportedreactions.com/drug/imovane/ 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 Imovane as a suspect or interacting product. The 7,822 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 Imovane 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 Imovane?

No. It is a count of what people reported to FDA: 2,986 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 (40.4%), physician (32.9%) and consumer or non-health professional (14.6%). 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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