Mexiletine adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Mexiletine
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 March 2004 to May 2026, FDA received 656 adverse event reports that name Mexiletine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 786 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 42 reports in the 12 months to June 2026 and 87 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, 42 (under 0.1%) name Mexiletine. Reports from consumers or other non-health professionals were 9.8% of the reports that name Mexiletine 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 Mexiletine 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 4 reports that name Mexiletine.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 27.

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 82 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 627 of the 656 reports (95.6%).

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 82 terms.

Reaction terms in the reports that name Mexiletine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 656 reports
Drug ineffectivethe medicine did not work as expected	264	40.2%
Weight increasedweight gain	84	12.8%
Off label useused for a purpose or in a way not on the label	74	11.3%
Fatiguetiredness	61	9.3%
Therapy non-responderthe treatment did not work	58	8.8%
Insomniadifficulty sleeping	55	8.4%
Contusiona bruise	47	7.2%
Poor quality sleep	46	7%
Herpes zostershingles	44	6.7%
Body tinea	43	6.6%
Bone density decreased	43	6.6%
Cellulitisa skin infection	43	6.6%
Glucose tolerance impaired	43	6.6%
Hyperlipidaemiaraised blood fats	43	6.6%
Hypertensionhigh blood pressure	43	6.6%
Infection susceptibility increased	43	6.6%
Oral herpesa cold sore	43	6.6%
Purpura	43	6.6%
Skin disorder	43	6.6%
Cataractclouding of the eye lens	42	6.4%
Inhibitory drug interaction	42	6.4%
Impaired quality of life	39	5.9%
Impaired work abilityreduced ability to work	38	5.8%
Immune thrombocytopenia	37	5.6%
Treatment failurethe treatment did not work	33	5%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	28	4.3%
Drug ineffective for unapproved indication	27	4.1%
Product use in unapproved indicationused for a purpose not on the label	24	3.7%
Drug interactionan interaction between medicines	23	3.5%
Electrocardiogram QT prolongeda QT prolongation on the ECG	22	3.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	17	2.6%
Completed suicidedeath by suicide	15	2.3%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	12	1.8%
Nauseafeeling sick	12	1.8%
Arrhythmic storm	11	1.7%
Dizzinesslight-headedness or unsteadiness	10	1.5%
Neurotoxicity	10	1.5%
Drug intolerancethe medicine was not tolerated	9	1.4%
Premature babya baby born early	9	1.4%
Disease recurrencethe disease came back	8	1.2%
Hyperthyroidismoveractive thyroid	8	1.2%
Hypotensionlow blood pressure	8	1.2%
Myoclonus	8	1.2%
Astheniaweakness or lack of energy	7	1.1%
Cardiac arrestthe heart stopped	7	1.1%
Condition aggravatedthe condition being treated got worse	7	1.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	7	1.1%
Muscle spasmsmuscle cramps	7	1.1%
Arthralgiajoint pain	6	0.9%
Atrophy	6	0.9%

Download all 82 terms of Mexiletine (CSV)

The counts add to more than 656 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 Mexiletine, 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	6	6	1	0	4	0	1	0
2005	4	3	1	0	3	0	1	1
2010	11	11	1	1	1	0	9	0
2012	2	2	0	0	2	0	1	0
2013	15	15	2	0	5	0	11	0
2014	22	21	1	0	5	0	17	1
2015	25	20	5	3	8	0	12	5
2016	6	5	1	0	2	1	2	1
2017	14	11	0	0	5	0	8	3
2018	24	18	0	3	12	1	17	6
2019	30	19	1	0	6	0	16	11
2020	52	48	2	3	17	0	37	4
2021	97	95	9	9	48	0	64	2
2022	77	69	8	5	38	0	46	8
2023	88	83	6	20	41	1	61	5
2024	84	78	14	13	37	0	44	6
2025	73	68	4	21	40	0	41	5
2026	26	26	9	7	18	0	9	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 Mexiletine, 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 Mexiletine, by the year in which FDA received them
Year	Reports
2004	6
2005	4
2010	11
2012	2
2013	16
2014	22
2015	26
2016	6
2017	17
2018	22
2019	33
2020	64
2021	108
2022	77
2023	79
2024	84
2025	65
2026	14

Reports that name Mexiletine, 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 Mexiletine
Age	Reports	Share
Under 2	26	4%
2 to 11	15	2.3%
12 to 17	14	2.1%
18 to 44	115	17.5%
45 to 64	196	29.9%
65 to 74	103	15.7%
75 and over	51	7.8%
Age not given	136	20.7%

Sex of the patient in the reports that name Mexiletine
Sex	Reports	Share
Female	283	43.1%
Male	306	46.6%
Unknown or not given	67	10.2%

Type of reporter in the reports that name Mexiletine
Reporter	Reports	Share
Physician	194	29.6%
Pharmacist	21	3.2%
Other health professional	360	54.9%
Lawyer	0	0%
Consumer or non-health professional	64	9.8%
Not given	17	2.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 57% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mexiletine record
Indication as recorded (MedDRA)	Reports	Share
Ventricular tachycardia	165	25.2%
Complex regional pain syndrome	88	13.4%
Arrhythmia	31	4.7%
Ventricular fibrillation	17	2.6%
Long QT syndrome	15	2.3%
Ventricular arrhythmia	12	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 656 reports.

Drugs in the same reports

Other drugs that the reports of Mexiletine name, in any role, in order of name
Drug	Reports that name the two
Amiodarone	212
Amitriptyline	76
Clonidine	86
Gabapentin	80
Ketamine	92
Lidocaine	176
Metoprolol	89
Prednisone	73
Pregabalin	97
Spironolactone	67

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 MexiletineThe 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. Mexiletine: adverse event reports that FDA received. https://reportedreactions.com/drug/mexiletine/ 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 Mexiletine as a suspect or interacting product. The 786 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 Mexiletine 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 Mexiletine?

No. It is a count of what people reported to FDA: 656 reports from March 2004 to May 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 (54.9%), physician (29.6%) and consumer or non-health professional (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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