Mianserin adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Mianserin /00390602/

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 1,378 adverse event reports that name Mianserin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 793 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 100 reports in the 12 months to June 2026 and 114 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, 100 (under 0.1%) name Mianserin. Reports from consumers or other non-health professionals were 7.2% of the reports that name Mianserin 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 Mianserin 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 29 reports that name Mianserin.
In January to March 2026, FDA received 14.
In April to June 2025, FDA received 28.

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 274 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 1,340 of the 1,378 reports (97.2%).

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 274 terms.

Reaction terms in the reports that name Mianserin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,378 reports
Toxicity to various agentspoisoning or toxic effect of one or more substances	184	13.4%
Drug interactionan interaction between medicines	145	10.5%
Somnolencedrowsiness	101	7.3%
Off label useused for a purpose or in a way not on the label	87	6.3%
Falla fall	82	6%
Drug ineffectivethe medicine did not work as expected	78	5.7%
Drug abusemisuse of a medicine	77	5.6%
Coma	73	5.3%
Confusional stateconfusion	63	4.6%
Condition aggravatedthe condition being treated got worse	58	4.2%
Poisoning deliberate	57	4.1%
Hypotensionlow blood pressure	56	4.1%
Nauseafeeling sick	55	4%
Hyponatraemialow blood sodium	51	3.7%
Anxiety	50	3.6%
Overdosea dose above the recommended amount	46	3.3%
Altered state of consciousness	45	3.3%
Fatiguetiredness	45	3.3%
Hyperhidrosisexcessive sweating	43	3.1%
Suicide attempta suicide attempt	43	3.1%
Bradycardiaslow heart rate	36	2.6%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	36	2.6%
Pleurothotonus	35	2.5%
Agranulocytosis	33	2.4%
Acute kidney injurysudden loss of kidney function	32	2.3%
Camptocormia	32	2.3%
Depressionlow mood	32	2.3%
Suicidal ideationthoughts of suicide	31	2.2%
Loss of consciousnesspassing out	30	2.2%
Completed suicidedeath by suicide	29	2.1%
Disturbance in attentiondifficulty concentrating	29	2.1%
Hepatocellular injury	29	2.1%
Drug dependencedependence on a medicine	28	2%
Extrapyramidal disordermovement problems such as stiffness or tremor	28	2%
Hepatic cytolysis	27	2%
Therapeutic product effect incomplete	27	2%
Diarrhoealoose or frequent stools	26	1.9%
Painpain, site not specified	26	1.9%
Hypertensionhigh blood pressure	24	1.7%
Weight increasedweight gain	24	1.7%
Deaththe patient died; cause not stated by this term	23	1.7%
Product use in unapproved indicationused for a purpose not on the label	23	1.7%
Sleep disordera sleep problem	23	1.7%
Dry mouth	22	1.6%
Tremorshaking	22	1.6%
Vertigoa spinning sensation	22	1.6%
Cardio-respiratory arrestthe heart and breathing stopped	21	1.5%
Fear	21	1.5%
Akathisiainner restlessness and an urge to move	20	1.5%
Cardiac arrestthe heart stopped	20	1.5%

Download all 274 terms of Mianserin (CSV)

The counts add to more than 1,378 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 Mianserin, 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	5	5	0	0	3	0	0	2	0
2005	10	10	2	0	6	0	1	6	0
2006	13	13	6	2	4	0	0	1	0
2007	8	7	0	0	5	0	0	2	1
2008	4	4	1	1	2	0	0	2	0
2009	9	9	1	0	5	0	0	4	0
2010	19	19	0	2	17	0	0	7	0
2011	21	21	2	0	17	0	0	8	0
2012	20	20	6	2	7	0	0	13	0
2013	15	15	5	2	10	0	1	4	0
2014	21	21	8	1	10	0	0	6	0
2015	27	26	2	2	21	0	0	8	1
2016	45	45	27	3	12	0	0	8	0
2017	48	48	12	3	22	1	0	27	0
2018	110	110	23	16	62	1	1	54	0
2019	178	177	33	12	89	3	0	88	1
2020	161	158	8	13	88	11	0	78	3
2021	105	104	10	9	54	15	0	63	1
2022	85	85	10	12	45	7	4	57	0
2023	130	129	30	19	45	5	0	79	1
2024	145	145	46	21	84	3	0	84	0
2025	141	141	15	24	78	12	1	93	0
2026	58	58	9	7	18	0	0	47	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 Mianserin, 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 Mianserin, by the year in which FDA received them
Year	Reports
2004	5
2005	10
2006	12
2007	12
2008	5
2009	10
2010	16
2011	23
2012	27
2013	16
2014	17
2015	29
2016	53
2017	67
2018	125
2019	184
2020	169
2021	98
2022	82
2023	122
2024	144
2025	109
2026	43

Reports that name Mianserin, 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 Mianserin
Age	Reports	Share
Under 2	0	0%
2 to 11	17	1.2%
12 to 17	8	0.6%
18 to 44	290	21%
45 to 64	362	26.3%
65 to 74	165	12%
75 and over	391	28.4%
Age not given	145	10.5%

Sex of the patient in the reports that name Mianserin
Sex	Reports	Share
Female	772	56%
Male	505	36.6%
Unknown or not given	101	7.3%

Type of reporter in the reports that name Mianserin
Reporter	Reports	Share
Physician	575	41.7%
Pharmacist	207	15%
Other health professional	462	33.5%
Lawyer	7	0.5%
Consumer or non-health professional	99	7.2%
Not given	28	2%

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 Mianserin record
Indication as recorded (MedDRA)	Reports	Share
Depression	336	24.4%
Bipolar disorder	45	3.3%
Antidepressant therapy	24	1.7%
Anxiety	23	1.7%
Insomnia	21	1.5%
Major depression	18	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,378 reports.

Drugs in the same reports

Other drugs that the reports of Mianserin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	123
Alprazolam	149
Diazepam	138
Lamotrigine	122
Oxazepam	122
Paracetamol	109
Quetiapine	120
Sertraline	122
Venlafaxine	207
Zolpidem	110

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

Miacalcin next in the A to Z list
Mianserin Hydrochloride next in the A to Z list
Mezavant next in the A to Z list
Mianserine next in the A to Z list
Mexiletine next in the A to Z list
Micafungin next in the A to Z list
Mevalotin next in the A to Z list
Micafungin sodium next in the A to Z list
Mevacor next in the A to Z list
Micardis next in the A to Z list
Metyrapone next in the A to Z list
Micardis HCT next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for MianserinThe 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. Mianserin: adverse event reports that FDA received. https://reportedreactions.com/drug/mianserin/ 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 Mianserin as a suspect or interacting product. The 793 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 Mianserin 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 Mianserin?

No. It is a count of what people reported to FDA: 1,378 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?

Physician (41.7%), other health professional (33.5%) and pharmacist (15%). 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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