Xenazine (tetrabenazine) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Tetrabenazine
Class: Vesicular monoamine transporter 2 inhibitor

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 March 2006 to March 2026, FDA received 6,375 adverse event reports that name Xenazine. In these reports the drug is a suspect or interacting product.

In the same period, 108 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 4 reports in the 12 months to June 2026 and 7 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, 4 (under 0.1%) name Xenazine. Reports from consumers or other non-health professionals were 62.7% of the reports that name Xenazine 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 Xenazine 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 0 reports that name Xenazine.
In January to March 2026, FDA received 2.
In April to June 2025, FDA received 2.

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 268 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 6,331 of the 6,375 reports (99.3%).

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 268 terms.

Reaction terms in the reports that name Xenazine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,375 reports
Deaththe patient died; cause not stated by this term	1,256	19.7%
Off label useused for a purpose or in a way not on the label	988	15.5%
Drug ineffectivethe medicine did not work as expected	492	7.7%
Depressionlow mood	431	6.8%
Somnolencedrowsiness	392	6.1%
Fatiguetiredness	315	4.9%
Hospitalisationadmission to hospital	277	4.3%
Intentional product use issuedeliberate use not as intended	271	4.3%
Falla fall	262	4.1%
Insomniadifficulty sleeping	248	3.9%
Drug administration errora mistake in giving the medicine	233	3.7%
Anxiety	218	3.4%
Drug dose omissiona dose was missed	216	3.4%
Prescribed overdose	189	3%
Tremorshaking	186	2.9%
Condition aggravatedthe condition being treated got worse	184	2.9%
Treatment noncompliancethe treatment was not taken as directed	178	2.8%
Movement disorder	174	2.7%
Dyskinesiainvoluntary movements	161	2.5%
Suicidal ideationthoughts of suicide	146	2.3%
Nauseafeeling sick	140	2.2%
Feeling abnormalfeeling odd or not right	137	2.1%
Gait disturbancedifficulty walking	131	2.1%
Agitationrestlessness	130	2%
Dysphagiadifficulty swallowing	129	2%
Dizzinesslight-headedness or unsteadiness	124	1.9%
Restlessness	110	1.7%
Vomitingbeing sick	108	1.7%
Pneumonialung infection	106	1.7%
Malaisegeneral feeling of being unwell	105	1.6%
Balance disorderproblems with balance	99	1.6%
Headachehead pain	93	1.5%
Weight decreasedweight loss	90	1.4%
Confusional stateconfusion	89	1.4%
Medication errora mistake in prescribing, dispensing or taking a medicine	88	1.4%
Aggressionaggressive behaviour	86	1.3%
Crying	86	1.3%
Astheniaweakness or lack of energy	85	1.3%
Abnormal behaviourunusual behaviour	78	1.2%
Anger	74	1.2%
Incorrect dose administeredthe wrong dose was given	74	1.2%
Dyspnoeashortness of breath	73	1.1%
Huntington's disease	70	1.1%
Musculoskeletal stiffnessstiffness in muscles or joints	70	1.1%
Investigation	69	1.1%
Painpain, site not specified	68	1.1%
Memory impairmentmemory problems	67	1.1%
No adverse eventno adverse event was reported	65	1%
Speech disordera speech problem	64	1%
Decreased appetitereduced appetite	62	1%

Download all 268 terms of Xenazine (CSV)

The counts add to more than 6,375 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 Tetrabenazine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Tetrabenazine	Generic name	905
Xenazine (this page)	Brand name	6,375

Sum of the separately reported names: 7,280. 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 Xenazine, 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
2006	3	3	0	0	3	0	0	0	0
2007	3	3	2	0	0	0	0	1	0
2008	4	1	1	1	1	0	0	0	3
2009	229	104	30	4	30	13	0	41	125
2010	383	227	80	11	50	15	0	108	156
2011	234	229	152	13	43	11	0	47	5
2012	280	276	141	11	69	9	0	83	4
2013	510	499	212	13	158	9	1	137	11
2014	1,444	693	295	2	269	4	0	274	751
2015	1,788	608	286	1	241	0	0	224	1,180
2016	515	238	111	4	97	4	0	58	277
2017	631	235	91	4	95	10	0	76	396
2018	174	135	86	0	40	0	0	36	39
2019	93	52	28	1	12	2	0	14	41
2020	30	28	14	0	11	1	0	7	2
2021	20	20	6	0	10	0	0	8	0
2022	10	10	3	0	5	0	0	4	0
2023	9	8	3	0	2	0	0	5	1
2024	5	5	1	0	2	0	0	2	0
2025	8	6	1	0	4	0	0	1	2
2026	2	1	0	0	1	0	0	0	1

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 Xenazine, 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 Xenazine, by the year in which FDA received them
Year	Reports
2006	3
2007	3
2008	1
2009	169
2010	436
2011	244
2012	290
2013	514
2014	1,536
2015	1,785
2016	496
2017	625
2018	124
2019	71
2020	33
2021	14
2022	9
2023	10
2024	4
2025	6
2026	2

Reports that name Xenazine, 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 Xenazine
Age	Reports	Share
Under 2	4	0.1%
2 to 11	108	1.7%
12 to 17	89	1.4%
18 to 44	553	8.7%
45 to 64	1,373	21.5%
65 to 74	735	11.5%
75 and over	602	9.4%
Age not given	2,911	45.7%

Sex of the patient in the reports that name Xenazine
Sex	Reports	Share
Female	3,709	58.2%
Male	2,596	40.7%
Unknown or not given	70	1.1%

Type of reporter in the reports that name Xenazine
Reporter	Reports	Share
Physician	626	9.8%
Pharmacist	625	9.8%
Other health professional	894	14%
Lawyer	6	0.1%
Consumer or non-health professional	3,994	62.7%
Not given	230	3.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 98.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Xenazine record
Indication as recorded (MedDRA)	Reports	Share
Huntington's disease	2,427	38.1%
Dyskinesia	550	8.6%
Chorea	413	6.5%
Huntington's disease	361	5.7%
Tardive dyskinesia	329	5.2%
Huntington's chorea	236	3.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,375 reports.

Pages near this one

Tetrabenazine same ingredient
Valbenazine same class
Ingrezza same class
Xembify next in the A to Z list
Xenical next in the A to Z list
Xelstrym next in the A to Z list
Xeomin next in the A to Z list
Xelpros next in the A to Z list
Xeplion next in the A to Z list
Xeloda next in the A to Z list
Xermelo next in the A to Z list
Xeljanz 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 XenazineThe 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. Xenazine: adverse event reports that FDA received. https://reportedreactions.com/drug/xenazine/ 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 Xenazine as a suspect or interacting product. The 108 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 Xenazine 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 Xenazine?

No. It is a count of what people reported to FDA: 6,375 reports from March 2006 to March 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?

Consumer or non-health professional (62.7%), other health professional (14%) and physician (9.8%). 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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