Tetrabenazine adverse event reports that FDA received

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

Name type: Generic name
Class: Vesicular monoamine transporter 2 inhibitor
Also reported as: Tetrabenazine 12 5mg, Tetrabenazine Tab 12 5mg, Tetrabenazine 25mg Tab

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 September 2004 to June 2026, FDA received 905 adverse event reports that name Tetrabenazine. In these reports the drug is a suspect or interacting product.

In the same period, 361 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 70 reports in the 12 months to June 2026 and 74 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 Tetrabenazine 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 18 reports that name Tetrabenazine.
In January to March 2026, FDA received 18.
In April to June 2025, FDA received 15.

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 83 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 841 of the 905 reports (92.9%).

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 83 terms.

Reaction terms in the reports that name Tetrabenazine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 905 reports
Drug ineffectivethe medicine did not work as expected	166	18.3%
Off label useused for a purpose or in a way not on the label	118	13%
Tardive dyskinesiainvoluntary repetitive movements	66	7.3%
Deaththe patient died; cause not stated by this term	58	6.4%
Drug ineffective for unapproved indication	58	6.4%
Dystoniainvoluntary muscle contractions	53	5.9%
Parkinsonism	49	5.4%
Somnolencedrowsiness	42	4.6%
Condition aggravatedthe condition being treated got worse	35	3.9%
Falla fall	33	3.6%
Depressionlow mood	31	3.4%
Suicidal ideationthoughts of suicide	28	3.1%
Drug interactionan interaction between medicines	27	3%
Hospitalisationadmission to hospital	27	3%
Sedationdrowsiness	26	2.9%
Fatiguetiredness	24	2.7%
Dyskinesiainvoluntary movements	22	2.4%
Akathisiainner restlessness and an urge to move	21	2.3%
Product substitution issuea problem after switching products	20	2.2%
Depressed moodlow mood	19	2.1%
Product use in unapproved indicationused for a purpose not on the label	19	2.1%
Extrapyramidal disordermovement problems such as stiffness or tremor	18	2%
Anxiety	17	1.9%
Vision blurredblurred vision	17	1.9%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	16	1.8%
Restlessness	16	1.8%
Treatment failurethe treatment did not work	16	1.8%
Treatment noncompliancethe treatment was not taken as directed	16	1.8%
Hallucinationseeing or hearing things that are not there	14	1.5%
Therapy non-responderthe treatment did not work	14	1.5%
Dysphagiadifficulty swallowing	13	1.4%
Hypersomniasleeping too much	13	1.4%
Respiratory failurethe lungs could not supply enough oxygen	13	1.4%
Visual acuity reducedreduced sharpness of vision	13	1.4%
Catatonia	12	1.3%
Hypoventilation	12	1.3%
Labelled drug-drug interaction medication error	12	1.3%
Pneumonialung infection	12	1.3%
Sedation complication	12	1.3%
Tremorshaking	12	1.3%
Acute kidney injurysudden loss of kidney function	10	1.1%
Deliriumsudden confusion	10	1.1%
Drug dose omissiona dose was missed	10	1.1%
Drug resistance	10	1.1%
Irritability	10	1.1%
Speech disordera speech problem	10	1.1%
Therapy cessation	10	1.1%
Therapy interrupted	10	1.1%
Adverse eventan unwanted medical event, type not specified	9	1%
Hypotensionlow blood pressure	9	1%

Download all 83 terms of Tetrabenazine (CSV)

The counts add to more than 905 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 (this page)	Generic name	905
Xenazine	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 Tetrabenazine, 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
2004	2	2	0	0	2	0	0	0
2007	2	2	0	1	1	0	0	0
2008	2	2	1	0	2	0	0	0
2009	6	6	1	0	3	0	2	0
2010	11	11	1	1	8	1	9	0
2011	12	12	0	0	3	1	10	0
2012	14	14	1	2	8	0	14	0
2013	15	14	0	1	8	1	13	1
2014	20	20	1	0	9	3	15	0
2015	16	5	0	0	0	0	5	11
2016	41	22	4	0	8	2	11	19
2017	78	34	9	2	12	0	15	44
2018	53	42	14	2	18	0	16	11
2019	72	33	4	1	18	1	12	39
2020	89	70	10	12	29	0	39	19
2021	128	111	6	3	50	0	66	17
2022	97	75	18	5	31	1	32	22
2023	66	57	7	8	35	0	27	9
2024	78	67	6	9	32	0	33	11
2025	60	51	7	2	13	1	33	9
2026	43	39	4	3	16	2	24	4

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 Tetrabenazine, 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 Tetrabenazine, by the year in which FDA received them
Year	Reports
2004	2
2007	2
2008	1
2009	9
2010	11
2011	12
2012	15
2013	12
2014	21
2015	25
2016	46
2017	82
2018	45
2019	76
2020	90
2021	126
2022	88
2023	67
2024	78
2025	61
2026	36

Reports that name Tetrabenazine, 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 Tetrabenazine
Age	Reports	Share
Under 2	8	0.9%
2 to 11	59	6.5%
12 to 17	79	8.7%
18 to 44	170	18.8%
45 to 64	135	14.9%
65 to 74	111	12.3%
75 and over	78	8.6%
Age not given	265	29.3%

Sex of the patient in the reports that name Tetrabenazine
Sex	Reports	Share
Female	441	48.7%
Male	400	44.2%
Unknown or not given	64	7.1%

Type of reporter in the reports that name Tetrabenazine
Reporter	Reports	Share
Physician	189	20.9%
Pharmacist	86	9.5%
Other health professional	413	45.6%
Lawyer	1	0.1%
Consumer or non-health professional	147	16.2%
Not given	69	7.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 58.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Tetrabenazine record
Indication as recorded (MedDRA)	Reports	Share
Huntington's disease	143	15.8%
Dystonia	78	8.6%
Chorea	63	7%
Dyskinesia	62	6.9%
Tardive dyskinesia	57	6.3%
Tourette's disorder	42	4.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 905 reports.

Drugs in the same reports

Other drugs that the reports of Tetrabenazine name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	61
Baclofen	108
Clonazepam	107
Clonidine	53
Diazepam	66
Gabapentin	49
Midazolam	88
Propofol	49
Risperidone	61
Trihexyphenidyl	60

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. The class page lists each drug of the class.

Official pages

DailyMed labels for TetrabenazineThe 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. Tetrabenazine: adverse event reports that FDA received. https://reportedreactions.com/drug/tetrabenazine/ 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 Tetrabenazine as a suspect or interacting product. The 361 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 Tetrabenazine 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 Tetrabenazine?

No. It is a count of what people reported to FDA: 905 reports from September 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 (45.6%), physician (20.9%) and consumer or non-health professional (16.2%). 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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