Fluvoxamine adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Fluvoxamine
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 June 2004 to June 2026, FDA received 1,994 adverse event reports that name Fluvoxamine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,866 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 183 reports in the 12 months to June 2026 and 192 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, 183 (under 0.1%) name Fluvoxamine. Reports from consumers or other non-health professionals were 11.8% of the reports that name Fluvoxamine 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 Fluvoxamine 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 51 reports that name Fluvoxamine.
In January to March 2026, FDA received 26.
In April to June 2025, FDA received 51.

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 246 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 1,956 of the 1,994 reports (98.1%).

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 246 terms.

Reaction terms in the reports that name Fluvoxamine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,994 reports
Drug interactionan interaction between medicines	418	21%
Drug ineffectivethe medicine did not work as expected	284	14.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	203	10.2%
Condition aggravatedthe condition being treated got worse	183	9.2%
Suicide attempta suicide attempt	156	7.8%
Off label useused for a purpose or in a way not on the label	152	7.6%
Suicidal ideationthoughts of suicide	145	7.3%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	123	6.2%
Hypotensionlow blood pressure	120	6%
Sedationdrowsiness	114	5.7%
Intentional overdosea deliberate overdose	111	5.6%
Completed suicidedeath by suicide	106	5.3%
Overdosea dose above the recommended amount	83	4.2%
Depressionlow mood	82	4.1%
Drug level increaseda raised blood level of the medicine	76	3.8%
Blood creatine phosphokinase increased	75	3.8%
Somnolencedrowsiness	73	3.7%
Deliriumsudden confusion	69	3.5%
Weight increasedweight gain	67	3.4%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	66	3.3%
Anxiety	64	3.2%
Confusional stateconfusion	58	2.9%
Constipation	57	2.9%
Electrocardiogram QT prolongeda QT prolongation on the ECG	57	2.9%
Schizophrenia	57	2.9%
Orthostatic hypotension	56	2.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	54	2.7%
Psychotic disordera loss of contact with reality	54	2.7%
Troponin increased	54	2.7%
Fatiguetiredness	53	2.7%
Toxic encephalopathy	50	2.5%
Aggressionaggressive behaviour	49	2.5%
Blood lactate dehydrogenase increased	48	2.4%
Drug abusemisuse of a medicine	47	2.4%
Nauseafeeling sick	47	2.4%
Seizurea fit or convulsion	47	2.4%
Vomitingbeing sick	47	2.4%
Amylase increased	46	2.3%
Apathy	46	2.3%
Blood potassium increased	46	2.3%
Myoglobin urine present	46	2.3%
Rhabdomyolysismuscle breakdown	46	2.3%
Tremorshaking	46	2.3%
Therapy non-responderthe treatment did not work	44	2.2%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	41	2.1%
Bradycardiaslow heart rate	40	2%
Loss of libido	40	2%
Tardive dyskinesiainvoluntary repetitive movements	39	2%
Treatment noncompliancethe treatment was not taken as directed	39	2%
Antipsychotic drug level increased	38	1.9%

Download all 246 terms of Fluvoxamine (CSV)

The counts add to more than 1,994 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 Fluvoxamine, 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	11	10	2	4	4	0	0	2	1
2005	13	12	1	1	7	0	0	4	1
2006	3	3	3	0	1	0	0	0	0
2008	3	2	0	0	1	0	0	1	1
2009	5	5	0	0	1	1	0	3	0
2010	16	16	1	1	2	0	1	11	0
2011	8	8	3	0	3	0	0	5	0
2012	8	8	4	0	4	1	0	4	0
2013	68	67	20	3	16	4	0	39	1
2014	77	74	19	3	23	1	0	38	3
2015	71	67	7	1	32	0	0	38	4
2016	86	71	9	5	29	1	0	43	15
2017	110	101	15	16	48	1	1	62	9
2018	146	130	15	6	64	4	2	84	16
2019	107	98	17	6	51	3	1	65	9
2020	151	139	46	6	54	3	0	88	12
2021	188	177	22	15	94	1	0	144	11
2022	212	196	38	16	105	7	0	141	16
2023	167	155	27	11	79	8	1	125	12
2024	169	154	26	16	100	2	0	117	15
2025	266	248	14	21	181	14	1	170	18
2026	109	98	5	27	80	1	0	75	11

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 Fluvoxamine, 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 Fluvoxamine, by the year in which FDA received them
Year	Reports
2004	11
2005	12
2006	4
2008	2
2009	6
2010	18
2011	13
2012	11
2013	70
2014	75
2015	78
2016	85
2017	119
2018	141
2019	117
2020	182
2021	183
2022	234
2023	164
2024	174
2025	218
2026	77

Reports that name Fluvoxamine, 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 Fluvoxamine
Age	Reports	Share
Under 2	6	0.3%
2 to 11	25	1.3%
12 to 17	173	8.7%
18 to 44	620	31.1%
45 to 64	502	25.2%
65 to 74	197	9.9%
75 and over	70	3.5%
Age not given	401	20.1%

Sex of the patient in the reports that name Fluvoxamine
Sex	Reports	Share
Female	881	44.2%
Male	902	45.2%
Unknown or not given	211	10.6%

Type of reporter in the reports that name Fluvoxamine
Reporter	Reports	Share
Physician	660	33.1%
Pharmacist	93	4.7%
Other health professional	942	47.2%
Lawyer	2	0.1%
Consumer or non-health professional	235	11.8%
Not given	62	3.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Fluvoxamine record
Indication as recorded (MedDRA)	Reports	Share
Depression	232	11.6%
Obsessive-compulsive disorder	172	8.6%
Schizophrenia	89	4.5%
Psychotic disorder	43	2.2%
Major depression	41	2.1%
Anxiety	29	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,994 reports.

Drugs in the same reports

Other drugs that the reports of Fluvoxamine name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	242
Clonazepam	216
Clozapine	324
Diazepam	182
Fluoxetine	207
Haloperidol	202
Lorazepam	250
Olanzapine	358
Quetiapine	439
Risperidone	309

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 FluvoxamineThe 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. Fluvoxamine: adverse event reports that FDA received. https://reportedreactions.com/drug/fluvoxamine/ 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 Fluvoxamine as a suspect or interacting product. The 1,866 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 Fluvoxamine 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 Fluvoxamine?

No. It is a count of what people reported to FDA: 1,994 reports from June 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 (47.2%), physician (33.1%) and consumer or non-health professional (11.8%). 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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