Vigabatrin adverse event reports that FDA received

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

Name type: Generic name
Class: Anti-epileptic agent
Also reported as: Vigabatrin 500mg, Vigabatrin 500mg 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.

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 February 2004 to June 2026, FDA received 3,664 adverse event reports that name Vigabatrin. In these reports the drug is a suspect or interacting product.

In the same period, 1,046 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 263 reports in the 12 months to June 2026 and 491 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, 263 (under 0.1%) name Vigabatrin. Reports from other health professionals were 51.9% of the reports that name Vigabatrin and 19.7% 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 Vigabatrin 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 52 reports that name Vigabatrin.
In January to March 2026, FDA received 73.
In April to June 2025, FDA received 153.

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 223 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 3,592 of the 3,664 reports (98%).

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 223 terms.

Reaction terms in the reports that name Vigabatrin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,664 reports
Seizurea fit or convulsion	657	17.9%
Drug ineffectivethe medicine did not work as expected	579	15.8%
Adverse eventan unwanted medical event, type not specified	245	6.7%
Deaththe patient died; cause not stated by this term	206	5.6%
Off label useused for a purpose or in a way not on the label	190	5.2%
Hospitalisationadmission to hospital	189	5.2%
Magnetic resonance imaging head abnormal	183	5%
Drug resistance	152	4.1%
Epilepsy	150	4.1%
Product use issuea problem in how the product was used	129	3.5%
Multiple-drug resistance	128	3.5%
Status epilepticus	116	3.2%
Somnolencedrowsiness	105	2.9%
Condition aggravatedthe condition being treated got worse	101	2.8%
Vomitingbeing sick	89	2.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	88	2.4%
Pneumonialung infection	87	2.4%
Product dose omission issuea dose was missed	86	2.3%
Treatment failurethe treatment did not work	78	2.1%
Therapy non-responderthe treatment did not work	64	1.7%
Encephalopathy	58	1.6%
Infantile spasms	56	1.5%
Therapy interrupted	52	1.4%
Drug interactionan interaction between medicines	50	1.4%
Neurotoxicity	46	1.3%
Pyrexiafever	46	1.3%
Therapeutic product effect incomplete	44	1.2%
Retinal disorder	43	1.2%
Magnetic resonance imaging brain abnormal	41	1.1%
Respiratory failurethe lungs could not supply enough oxygen	38	1%
Therapy cessation	38	1%
Product substitution issuea problem after switching products	36	1%
Aggressionaggressive behaviour	32	0.9%
Cerebral disorder	32	0.9%
Muscle spasmsmuscle cramps	32	0.9%
Rashskin rash	32	0.9%
Gaze palsy	31	0.8%
Irritability	31	0.8%
Nasopharyngitisa cold	31	0.8%
Partial seizures	31	0.8%
Tremorshaking	31	0.8%
Hypotonia	29	0.8%
Decreased appetitereduced appetite	28	0.8%
Abnormal behaviourunusual behaviour	27	0.7%
Fatiguetiredness	27	0.7%
Urinary tract infectionbladder or urinary infection	27	0.7%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	26	0.7%
Ataxia	26	0.7%
Dyspnoeashortness of breath	26	0.7%
Lethargysluggishness	26	0.7%

Download all 223 terms of Vigabatrin (CSV)

The counts add to more than 3,664 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 Vigabatrin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Vigabatrin (this page)	Generic name	3,664
Sabril	Brand name	10,909
Vigadrone	Brand name	399
Vigafyde	Brand name	252

Sum of the separately reported names: 15,224. 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 Vigabatrin, 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	6	6	1	0	2	1	2	3	0
2005	11	11	0	0	3	0	2	8	0
2006	11	11	0	0	6	0	0	5	0
2007	0	0	0	0	0	0	0	0	0
2008	19	19	3	0	5	0	8	6	0
2009	23	23	1	3	3	0	3	15	0
2010	9	7	0	0	2	0	4	2	2
2011	6	6	1	0	3	0	0	4	0
2012	3	3	1	0	1	0	0	3	0
2013	32	31	3	0	14	0	1	19	1
2014	80	79	4	0	22	0	4	56	1
2015	42	37	4	2	4	0	1	34	5
2016	37	34	4	0	5	1	0	28	3
2017	50	48	1	10	7	1	1	43	2
2018	171	139	8	1	65	2	0	84	32
2019	264	214	20	1	70	0	1	142	50
2020	335	301	112	11	101	4	1	151	34
2021	430	373	58	21	156	3	1	206	57
2022	478	374	40	9	153	11	1	232	104
2023	465	306	20	3	139	1	0	187	159
2024	572	448	40	9	219	4	0	267	124
2025	480	378	41	29	191	3	1	248	102
2026	140	105	7	0	49	0	0	65	35

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 Vigabatrin, 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 Vigabatrin, by the year in which FDA received them
Year	Reports
2004	6
2005	11
2006	11
2008	20
2009	20
2010	13
2011	6
2012	7
2013	34
2014	78
2015	39
2016	38
2017	54
2018	190
2019	286
2020	365
2021	440
2022	473
2023	490
2024	569
2025	389
2026	125

Reports that name Vigabatrin, 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 Vigabatrin
Age	Reports	Share
Under 2	749	20.4%
2 to 11	610	16.6%
12 to 17	84	2.3%
18 to 44	249	6.8%
45 to 64	36	1%
65 to 74	2	0.1%
75 and over	3	0.1%
Age not given	1,931	52.7%

Sex of the patient in the reports that name Vigabatrin
Sex	Reports	Share
Female	1,448	39.5%
Male	1,609	43.9%
Unknown or not given	607	16.6%

Type of reporter in the reports that name Vigabatrin
Reporter	Reports	Share
Physician	503	13.7%
Pharmacist	209	5.7%
Other health professional	1,901	51.9%
Lawyer	1	under 0.1%
Consumer or non-health professional	959	26.2%
Not given	91	2.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 64.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Vigabatrin record
Indication as recorded (MedDRA)	Reports	Share
Epilepsy	844	23%
Infantile spasms	840	22.9%
Seizure	498	13.6%
Lennox-gastaut syndrome	101	2.8%
Partial seizures	100	2.7%
Tuberous sclerosis complex	71	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,664 reports.

Drugs in the same reports

Other drugs that the reports of Vigabatrin name, in any role, in order of name
Drug	Reports that name the two
Carbamazepine	426
Clobazam	636
Clonazepam	409
Keppra	276
Lamotrigine	426
Levetiracetam	817
Phenobarbital	536
Phenytoin	339
Topiramate	678
Valproic acid	439

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

Sabril same ingredient
Vigadrone same ingredient
Vigafyde same ingredient
Valproic acid same class
Valproate sodium same class
Trileptal same class
Zarontin same class
Viekirax next in the A to Z list
Viekira Pak next in the A to Z list
Videx Ec next in the A to Z list
Vigamox next in the A to Z list
Videx 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 VigabatrinThe 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. Vigabatrin: adverse event reports that FDA received. https://reportedreactions.com/drug/vigabatrin/ 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 Vigabatrin as a suspect or interacting product. The 1,046 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 Vigabatrin 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 Vigabatrin?

No. It is a count of what people reported to FDA: 3,664 reports from February 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 (51.9%), consumer or non-health professional (26.2%) and physician (13.7%). 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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