Robaxin (methocarbamol) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Methocarbamol
Class: Muscle relaxant

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 June 2026, FDA received 584 adverse event reports that name Robaxin. In these reports the drug is a suspect or interacting product.

In the same period, 5,604 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 29 reports in the 12 months to June 2026 and 40 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, 29 (under 0.1%) name Robaxin. Reports for female patients were 69.9% of the reports that name Robaxin and 52.7% 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 Robaxin 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 Robaxin.
In January to March 2026, FDA received 8.
In April to June 2025, FDA received 5.

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 86 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

This list is partial.

It covers 516 of the 584 reports (88.4%).

The site keeps reaction terms only for years in which the drug has 12 or more reports.

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 86 terms.

Reaction terms in the reports that name Robaxin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 584 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	109	18.7%
Drug ineffectivethe medicine did not work as expected	56	9.6%
Painpain, site not specified	43	7.4%
Completed suicidedeath by suicide	34	5.8%
Muscle spasmsmuscle cramps	34	5.8%
Vomitingbeing sick	29	5%
Diarrhoealoose or frequent stools	28	4.8%
Nauseafeeling sick	28	4.8%
Cough	26	4.5%
Cystitis	22	3.8%
Influenzaflu	22	3.8%
Abdominal pain upperupper stomach pain	21	3.6%
Alanine aminotransferase increasedraised liver enzyme (ALT)	21	3.6%
Aspartate aminotransferase increasedraised liver enzyme (AST)	21	3.6%
Rhinorrhoeaa runny nose	21	3.6%
Gallbladder polyp	20	3.4%
Liver disorder	20	3.4%
Oesophagitis	20	3.4%
Pyrexiafever	20	3.4%
Hypokalaemialow blood potassium	19	3.3%
Hypertensionhigh blood pressure	18	3.1%
Fibromyalgia	17	2.9%
Somnolencedrowsiness	17	2.9%
Back pain	16	2.7%
Arthralgiajoint pain	15	2.6%
Anal fissure haemorrhage	13	2.2%
Anal fistula	13	2.2%
Depressionlow mood	13	2.2%
Dizzinesslight-headedness or unsteadiness	13	2.2%
Impaired work abilityreduced ability to work	13	2.2%
Malaisegeneral feeling of being unwell	13	2.2%
Mental status changes	13	2.2%
Cardio-respiratory arrestthe heart and breathing stopped	12	2.1%
Fistula discharge	12	2.1%
Gastrooesophageal reflux diseaseacid reflux	12	2.1%
Impaired quality of life	12	2.1%
Confusional stateconfusion	11	1.9%
Angina pectoris	10	1.7%
Atrial fibrillationan irregular heart rhythm	10	1.7%
Drug dependencedependence on a medicine	10	1.7%
Dysphagiadifficulty swallowing	10	1.7%
Falla fall	10	1.7%
Haemorrhoids	10	1.7%
Hypothyroidismunderactive thyroid	10	1.7%
Lymphadenopathyswollen lymph nodes	10	1.7%
Malabsorption	10	1.7%
Myoclonus	10	1.7%
Off label useused for a purpose or in a way not on the label	10	1.7%
Osteoporosisthinning of the bones	10	1.7%
Proctalgia	10	1.7%

Download all 86 terms of Robaxin (CSV)

The counts add to more than 584 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 Methocarbamol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Methocarbamol	Generic name	2,111
Robaxin (this page)	Brand name	584

Sum of the separately reported names: 2,695. 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 Robaxin, 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	8	3	0	0	2	0	0	1	5
2005	6	2	0	1	2	0	0	0	4
2006	10	9	0	1	2	0	0	6	1
2007	7	5	5	0	1	0	0	0	2
2008	5	3	0	1	2	1	1	2	2
2009	6	6	0	0	5	0	0	2	0
2010	6	5	0	0	3	0	0	3	1
2011	9	9	0	2	5	0	0	3	0
2012	11	5	0	1	2	0	0	3	6
2013	38	24	0	6	18	3	0	10	14
2014	22	14	0	1	6	0	0	11	8
2015	41	19	0	3	5	0	1	13	22
2016	46	10	0	0	4	0	0	8	36
2017	47	19	5	0	8	1	0	11	28
2018	23	8	3	2	4	3	0	5	15
2019	54	16	3	0	2	2	0	10	38
2020	61	39	5	0	18	1	0	22	22
2021	40	27	4	2	6	0	0	22	13
2022	23	20	8	1	1	0	0	12	3
2023	24	20	11	1	5	0	0	6	4
2024	32	28	5	6	18	0	0	10	4
2025	46	32	11	2	8	1	0	17	14
2026	19	13	7	0	2	0	0	6	6

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 Robaxin, 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 Robaxin, by the year in which FDA received them
Year	Reports
2004	8
2005	5
2006	11
2007	7
2008	5
2009	8
2010	6
2011	10
2012	16
2013	36
2014	26
2015	44
2016	47
2017	51
2018	23
2019	52
2020	68
2021	31
2022	20
2023	24
2024	27
2025	47
2026	12

Reports that name Robaxin, 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 Robaxin
Age	Reports	Share
Under 2	1	0.2%
2 to 11	1	0.2%
12 to 17	11	1.9%
18 to 44	72	12.3%
45 to 64	198	33.9%
65 to 74	53	9.1%
75 and over	27	4.6%
Age not given	221	37.8%

Sex of the patient in the reports that name Robaxin
Sex	Reports	Share
Female	408	69.9%
Male	124	21.2%
Unknown or not given	52	8.9%

Type of reporter in the reports that name Robaxin
Reporter	Reports	Share
Physician	181	31%
Pharmacist	33	5.7%
Other health professional	101	17.3%
Lawyer	8	1.4%
Consumer or non-health professional	232	39.7%
Not given	29	5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 86.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Robaxin record
Indication as recorded (MedDRA)	Reports	Share
Muscle spasms	50	8.6%
Back pain	20	3.4%
Pain	20	3.4%
Fibromyalgia	4	0.7%
Muscle relaxant therapy	4	0.7%
Muscle disorder	2	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 584 reports.

Pages near this one

Methocarbamol same ingredient
Soma same class
Metaxalone same class
Cyclobenzaprine hydrochloride same class
Roacutan next in the A to Z list
Robitussin next in the A to Z list
Roactemra next in the A to Z list
Rocaltrol next in the A to Z list
Roaccutane next in the A to Z list
Rocefin next in the A to Z list
Roaccutan next in the A to Z list
Rocephin 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 RobaxinThe 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. Robaxin: adverse event reports that FDA received. https://reportedreactions.com/drug/robaxin/ 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 Robaxin as a suspect or interacting product. The 5,604 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 Robaxin 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 Robaxin?

No. It is a count of what people reported to FDA: 584 reports from March 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?

Consumer or non-health professional (39.7%), physician (31%) and other health professional (17.3%). 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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