Cyclobenzaprine hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Muscle relaxant
Also reported as: Cyclobenzaprine Hydrochloride 10mg, Cyclobenzaprine Hydrochloride 5mg, Cyclobenzaprine Hydrochloride Tablets Usp

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 1,591 adverse event reports that name Cyclobenzaprine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 6,590 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 115 reports in the 12 months to June 2026 and 111 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, 115 (under 0.1%) name Cyclobenzaprine hydrochloride. Reports from other health professionals were 48.1% of the reports that name Cyclobenzaprine hydrochloride 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 Cyclobenzaprine hydrochloride 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 18 reports that name Cyclobenzaprine hydrochloride.
In January to March 2026, FDA received 42.
In April to June 2025, FDA received 14.

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 252 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 1,528 of the 1,591 reports (96%).

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 252 terms.

Reaction terms in the reports that name Cyclobenzaprine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,591 reports
Painpain, site not specified	707	44.4%
Constipation	531	33.4%
Headachehead pain	383	24.1%
Hepatic enzyme increasedraised liver enzymes	375	23.6%
Off label useused for a purpose or in a way not on the label	371	23.3%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	370	23.3%
Hyperhidrosisexcessive sweating	363	22.8%
Hypersensitivityan allergic-type reaction	361	22.7%
Immunodeficiency	360	22.6%
Food allergy	352	22.1%
Asthma	336	21.1%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	332	20.9%
Upper respiratory tract infectiona cold or similar infection	329	20.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	327	20.6%
Rash erythematousa red rash	326	20.5%
Fatiguetiredness	323	20.3%
Fluid retentionthe body holding extra fluid	313	19.7%
Temperature regulation disorder	310	19.5%
Bursitis	308	19.4%
Drug intolerancethe medicine was not tolerated	307	19.3%
Coeliac disease	301	18.9%
Drug ineffectivethe medicine did not work as expected	298	18.7%
Erythemaskin redness	292	18.4%
Back pain	291	18.3%
Overdosea dose above the recommended amount	288	18.1%
Contraindicated product administered	264	16.6%
Falla fall	259	16.3%
Hypotensionlow blood pressure	254	16%
Depressed level of consciousness	252	15.8%
Cognitive disorderproblems with thinking or memory	250	15.7%
Hypertensionhigh blood pressure	249	15.7%
Mobility decreasedreduced ability to move about	249	15.7%
Balance disorderproblems with balance	246	15.5%
Sedationdrowsiness	244	15.3%
Sedation complication	241	15.1%
Joint swellinga swollen joint	239	15%
Blood calcium decreased	238	15%
Creatinine renal clearance decreased	238	15%
Orthostatic hypotension	238	15%
Product use issuea problem in how the product was used	234	14.7%
Prescribed overdose	231	14.5%
Exposure during pregnancythe medicine was taken during pregnancy	229	14.4%
Rashskin rash	226	14.2%
Infusion related reactiona reaction during or soon after an infusion	222	14%
Intentional product misusedeliberate use not as intended	215	13.5%
Pyrexiafever	209	13.1%
Thrombocytopenialow platelets	202	12.7%
Treatment failurethe treatment did not work	198	12.4%
Psoriasispsoriasis, a skin condition	190	11.9%
Foetal death	163	10.2%

Download all 252 terms of Cyclobenzaprine hydrochloride (CSV)

The counts add to more than 1,591 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 Cyclobenzaprine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Cyclobenzaprine	Generic name	8,750
Cyclobenzaprine hydrochloride (this page)	Generic name	1,591
Amrix	Brand name	217

Sum of the separately reported names: 10,558. 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 Cyclobenzaprine hydrochloride, 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	15	13	9	0	6	1	0	11	2
2005	0	0	0	0	0	0	0	0	0
2006	4	4	1	2	1	0	0	1	0
2007	5	5	5	0	0	0	0	0	0
2008	18	18	13	0	2	1	0	2	0
2009	15	14	13	0	0	0	0	1	1
2010	36	34	28	0	3	0	0	5	2
2011	61	58	50	0	3	0	0	6	3
2012	16	15	7	1	5	0	0	6	1
2013	36	20	9	0	4	0	0	8	16
2014	27	16	2	1	8	0	1	12	11
2015	101	84	73	2	4	0	0	11	17
2016	48	10	0	0	5	0	0	8	38
2017	63	48	41	3	17	0	0	9	15
2018	45	27	10	4	9	0	0	22	18
2019	77	59	13	1	9	0	0	55	18
2020	101	94	13	4	34	1	0	82	7
2021	190	181	9	7	113	1	0	165	9
2022	160	151	4	14	100	3	0	137	9
2023	139	127	4	17	30	2	0	124	12
2024	175	159	26	19	28	5	2	150	16
2025	141	131	59	38	48	22	19	126	10
2026	118	105	58	23	33	17	17	95	13

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 Cyclobenzaprine hydrochloride, 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 Cyclobenzaprine hydrochloride, by the year in which FDA received them
Year	Reports
2004	14
2005	1
2006	2
2007	5
2008	20
2009	14
2010	34
2011	64
2012	17
2013	36
2014	30
2015	100
2016	51
2017	65
2018	60
2019	97
2020	106
2021	220
2022	157
2023	170
2024	179
2025	89
2026	60

Reports that name Cyclobenzaprine hydrochloride, 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 Cyclobenzaprine hydrochloride
Age	Reports	Share
Under 2	4	0.3%
2 to 11	4	0.3%
12 to 17	11	0.7%
18 to 44	325	20.4%
45 to 64	448	28.2%
65 to 74	51	3.2%
75 and over	259	16.3%
Age not given	489	30.7%

Sex of the patient in the reports that name Cyclobenzaprine hydrochloride
Sex	Reports	Share
Female	1,139	71.6%
Male	196	12.3%
Unknown or not given	256	16.1%

Type of reporter in the reports that name Cyclobenzaprine hydrochloride
Reporter	Reports	Share
Physician	243	15.3%
Pharmacist	154	9.7%
Other health professional	765	48.1%
Lawyer	4	0.3%
Consumer or non-health professional	382	24%
Not given	43	2.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 44.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cyclobenzaprine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Eczema	357	22.4%
Pain	72	4.5%
Fibromyalgia	40	2.5%
Muscle spasms	29	1.8%
Back pain	26	1.6%
Suicide attempt	24	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,591 reports.

Drugs in the same reports

Other drugs that the reports of Cyclobenzaprine hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	611
Actemra	439
Bupropion hydrochloride	417
Cetirizine hydrochloride	432
Citalopram hydrobromide	425
Cyclobenzaprine	425
Furosemide	544
Morphine sulfate	480
Orencia	443
Vitamin c	536

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

Cyclobenzaprine same ingredient
Amrix same ingredient
Cyclobenzaprine hcl same class
Metaxalone same class
Methocarbamol same class
Chlorzoxazone same class
Robaxin same class
Cyclopentolate hydrochloride next in the A to Z list
Cyclophosphamid next in the A to Z list
Cyclizine next in the A to Z list
Cyclophosphamide next in the A to Z list
Cyanokit 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 Cyclobenzaprine hydrochlorideThe 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. Cyclobenzaprine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/cyclobenzaprine-hydrochloride/ 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 Cyclobenzaprine hydrochloride as a suspect or interacting product. The 6,590 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 Cyclobenzaprine hydrochloride 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 Cyclobenzaprine hydrochloride?

No. It is a count of what people reported to FDA: 1,591 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?

Other health professional (48.1%), consumer or non-health professional (24%) and physician (15.3%). 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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