Asenapine adverse event reports that FDA received

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

Name type: Generic name
Class: Atypical antipsychotic

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 August 2010 to June 2026, FDA received 622 adverse event reports that name Asenapine. In these reports the drug is a suspect or interacting product.

In the same period, 221 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 32 reports in the 12 months to June 2026 and 50 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 Asenapine 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 5 reports that name Asenapine.
In January to March 2026, FDA received 13.
In April to June 2025, FDA received 22.

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 117 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 612 of the 622 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 117 terms.

Reaction terms in the reports that name Asenapine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 622 reports
Drug ineffectivethe medicine did not work as expected	78	12.5%
Completed suicidedeath by suicide	71	11.4%
Drug interactionan interaction between medicines	67	10.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	61	9.8%
Off label useused for a purpose or in a way not on the label	37	5.9%
Myocarditisinflammation of the heart muscle	35	5.6%
Product substitution issuea problem after switching products	29	4.7%
Sedationdrowsiness	26	4.2%
Anxiety	21	3.4%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	20	3.2%
Dystoniainvoluntary muscle contractions	19	3.1%
Product solubility abnormal	19	3.1%
Treatment failurethe treatment did not work	19	3.1%
Akathisiainner restlessness and an urge to move	18	2.9%
Condition aggravatedthe condition being treated got worse	18	2.9%
Somnolencedrowsiness	18	2.9%
Schizophrenia	17	2.7%
Depressionlow mood	16	2.6%
Insomniadifficulty sleeping	16	2.6%
Electrocardiogram QT prolongeda QT prolongation on the ECG	15	2.4%
Hypotensionlow blood pressure	15	2.4%
Suicidal ideationthoughts of suicide	15	2.4%
Constipation	14	2.3%
Product use in unapproved indicationused for a purpose not on the label	14	2.3%
Vomitingbeing sick	14	2.3%
Cardio-respiratory arrestthe heart and breathing stopped	13	2.1%
Depressed moodlow mood	13	2.1%
Hallucination, auditory	13	2.1%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	13	2.1%
Parkinsonism	13	2.1%
Extrapyramidal disordermovement problems such as stiffness or tremor	12	1.9%
Weight increasedweight gain	12	1.9%
Cardiac arrestthe heart stopped	11	1.8%
Deaththe patient died; cause not stated by this term	11	1.8%
Dyspnoeashortness of breath	11	1.8%
Mental impairmentreduced thinking ability	11	1.8%
Nauseafeeling sick	11	1.8%
Weight decreasedweight loss	11	1.8%
Delusiona fixed false belief	10	1.6%
Disease recurrencethe disease came back	10	1.6%
Seizurea fit or convulsion	10	1.6%
Therapeutic product effect incomplete	10	1.6%
Agitationrestlessness	9	1.4%
Congestive cardiomyopathy	9	1.4%
Dizzinesslight-headedness or unsteadiness	9	1.4%
Restlessness	9	1.4%
Syncopefainting	9	1.4%
Tremorshaking	9	1.4%
Acute kidney injurysudden loss of kidney function	8	1.3%
Aspirationbreathing material into the lungs	8	1.3%

Download all 117 terms of Asenapine (CSV)

The counts add to more than 622 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 Asenapine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Asenapine (this page)	Generic name	622
Asenapine maleate	Generic name	442
Saphris	Brand name	6,496

Sum of the separately reported names: 7,560. 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 Asenapine, 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	Other Serious (Important Medical Events)	Not serious
2010	2	2	0	0	0	0	2	0
2011	8	7	0	0	3	0	4	1
2012	16	13	0	1	11	0	2	3
2013	12	11	1	0	3	0	8	1
2014	54	41	6	6	17	3	18	13
2015	80	74	36	1	19	1	35	6
2016	67	53	10	2	30	2	29	14
2017	36	34	10	1	11	0	19	2
2018	19	17	8	2	8	0	8	2
2019	32	32	16	0	15	0	16	0
2020	25	24	9	0	11	0	17	1
2021	56	40	5	0	18	0	34	16
2022	70	55	0	1	28	2	44	15
2023	40	28	7	0	15	0	21	12
2024	20	15	3	0	4	1	13	5
2025	65	46	3	9	26	0	35	19
2026	20	18	13	2	5	0	13	2

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 Asenapine, 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 Asenapine, by the year in which FDA received them
Year	Reports
2010	2
2011	8
2012	16
2013	12
2014	59
2015	82
2016	65
2017	37
2018	18
2019	38
2020	30
2021	53
2022	69
2023	37
2024	20
2025	58
2026	18

Reports that name Asenapine, 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 Asenapine
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	13	2.1%
18 to 44	215	34.6%
45 to 64	196	31.5%
65 to 74	41	6.6%
75 and over	24	3.9%
Age not given	133	21.4%

Sex of the patient in the reports that name Asenapine
Sex	Reports	Share
Female	297	47.7%
Male	249	40%
Unknown or not given	76	12.2%

Type of reporter in the reports that name Asenapine
Reporter	Reports	Share
Physician	183	29.4%
Pharmacist	40	6.4%
Other health professional	295	47.4%
Lawyer	0	0%
Consumer or non-health professional	90	14.5%
Not given	14	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 64.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Asenapine record
Indication as recorded (MedDRA)	Reports	Share
Bipolar disorder	82	13.2%
Schizophrenia	71	11.4%
Bipolar i disorder	31	5%
Depression	14	2.3%
Schizoaffective disorder	14	2.3%
Mood swings	13	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 622 reports.

Pages near this one

Asenapine maleate same ingredient
Saphris same ingredient
Aristada Initio same class
Aristada same class
Brexpiprazole same class
Aripiprazole same class
Caplyta same class
Ascorbic acid next in the A to Z list
Asclera next in the A to Z list
Asenapine Maleate - Bp next in the A to Z list
Asciminib next in the A to Z list
Asfotase alfa 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 AsenapineThe 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. Asenapine: adverse event reports that FDA received. https://reportedreactions.com/drug/asenapine/ 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 Asenapine as a suspect or interacting product. The 221 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 Asenapine 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 Asenapine?

No. It is a count of what people reported to FDA: 622 reports from August 2010 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 (47.4%), physician (29.4%) and consumer or non-health professional (14.5%). 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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