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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE" /><meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]" /><meta name="citation_title" content="Cyclobenzaprine" /><meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="citation_date" content="2017/01/30" /><meta name="citation_pmid" content="31644201" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK548894/" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Cyclobenzaprine" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases" /><meta name="DC.Date" content="2017/01/30" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK548894/" /><meta name="description" content="Cyclobenzaprine is a centrally acting muscle relaxant closely related to the tricyclic antidepressants. Despite its similarity to tricyclic antidepressants, there is little evidence that cyclobenzaprine causes liver injury." /><meta name="og:title" content="Cyclobenzaprine" /><meta name="og:type" content="book" /><meta name="og:description" content="Cyclobenzaprine is a centrally acting muscle relaxant closely related to the tricyclic antidepressants. Despite its similarity to tricyclic antidepressants, there is little evidence that cyclobenzaprine causes liver injury." /><meta name="og:url" content="https://www.ncbi.nlm.nih.gov/books/NBK548894/" /><meta name="og:site_name" content="NCBI Bookshelf" /><meta name="og:image" content="https://www.ncbi.nlm.nih.gov/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" /><meta name="twitter:card" content="summary" /><meta name="twitter:site" content="@ncbibooks" /><meta name="bk-non-canon-loc" content="/books/n/livertox/Cyclobenzaprine/" /><link rel="canonical" href="https://www.ncbi.nlm.nih.gov/books/NBK548894/" /><link rel="stylesheet" href="/corehtml/pmc/css/figpopup.css" type="text/css" media="screen" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books.min.css" type="text/css" /><link rel="stylesheet" href="/corehtml/pmc/css/bookshelf/2.26/css/books_print.min.css" type="text/css" media="print" /><style type="text/css">p a.figpopup{display:inline !important} .bk_tt {font-family: monospace} .first-line-outdent .bk_ref {display: inline} .body-content h2, .body-content .h2 {border-bottom: 1px solid #97B0C8} .body-content h2.inline {border-bottom: none} a.page-toc-label , .jig-ncbismoothscroll a {text-decoration:none;border:0 !important} .temp-labeled-list .graphic {display:inline-block !important} .temp-labeled-list img{width:100%}</style><script type="text/javascript" src="/corehtml/pmc/js/jquery.hoverIntent.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/common.min.js?_=3.18"> </script><script type="text/javascript" src="/corehtml/pmc/js/large-obj-scrollbars.min.js"> </script><script type="text/javascript">window.name="mainwindow";</script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/book-toc.min.js"> </script><script type="text/javascript" src="/corehtml/pmc/js/bookshelf/2.26/books.min.js"> </script><meta name="book-collection" content="NONE" />
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<div class="pre-content"><div><div class="bk_prnt"><p class="small">NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.</p><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. </p></div><div class="iconblock clearfix whole_rhythm no_top_margin bk_noprnt"><a class="img_link icnblk_img" title="All Drug Records" href="/books/n/livertox/"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-livertox-lrg.png" alt="Cover of LiverTox" height="100px" width="80px" /></a><div class="icnblk_cntnt eight_col"><h2>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].</h2><a data-jig="ncbitoggler" href="#__NBK548894_dtls__">Show details</a><div style="display:none" class="ui-widget" id="__NBK548894_dtls__"><div>Bethesda (MD): <a href="https://www.niddk.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Diabetes and Digestive and Kidney Diseases</a>; 2012-.</div></div><div class="half_rhythm"><ul class="inline_list"><li style="margin-right:1em"><a class="bk_cntns" href="/books/n/livertox/">Drug Records</a></li></ul></div><div class="bk_noprnt"><form method="get" action="/books/n/livertox/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div><div class="icnblk_cntnt two_col"><div class="pagination bk_noprnt"><a class="active page_link prev" href="/books/n/livertox/CyclizineChlorcycl/" title="Previous page in this title">< Prev</a><a class="active page_link next" href="/books/n/livertox/Cyclophosphamide/" title="Next page in this title">Next ></a></div></div></div></div></div>
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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><h1 id="_NBK548894_"><span class="title" itemprop="name">Cyclobenzaprine</span></h1><p class="small">Last Update: <span itemprop="dateModified">January 30, 2017</span>.</p></div><div class="body-content whole_rhythm" itemprop="text"><div id="Cyclobenzaprine.OVERVIEW"><h2 id="_Cyclobenzaprine_OVERVIEW_">OVERVIEW</h2><div id="Cyclobenzaprine.Introduction"><h3>Introduction</h3><p>Cyclobenzaprine is a centrally acting muscle relaxant closely related to the tricyclic antidepressants. Despite its similarity to tricyclic antidepressants, there is little evidence that cyclobenzaprine causes liver injury.</p></div><div id="Cyclobenzaprine.Background"><h3>Background</h3><p>Cyclobenzaprine (sye" kloe ben' za preen) is a tricyclic antidepressant derivative that relaxes skeletal muscle by an unknown mechanism of action. Cyclobenzaprine is also a central nervous system depressant, and its efficacy may be related to its sedative effects. Cyclobenzaprine is used for the treatment of painful muscle spasms from acute muscle conditions. The recommended dosage in adults is 5 to 10 mg three times daily for 3 to 4 weeks. Cyclobenzaprine is available in tablets of 5 and 10 mg in multiple generic forms and under the trade names of Flexeril, Flexamid and Amrix. Extended release capsules of 15 and 30 mg are also available. Cyclobenzaprine was approved for use in the United States in 1977 and it remains widely used with more than 10 million prescriptions filled yearly. It is usually administered for limited periods of time. Common side effects include sleepiness, dry mouth, dizziness and headache.</p></div><div id="Cyclobenzaprine.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>The product insert for cyclobenzaprine mentions that abnormal liver function, hepatitis, jaundice, and cholestasis occur in <1% of patients. Details about these cases are not available and no convincing case reports of cyclobenzaprine hepatotoxicity have been published.</p><p><a class="def" href="/books/n/livertox/glossary/def-item/glossary.likelihood-score/">Likelihood score</a>: E* (Unproven but suspected cause of clinically apparent liver injury).</p></div><div id="Cyclobenzaprine.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>Because cyclobenzaprine is a tricyclic antidepressant derivative, it is unclear why it is not associated with hepatotoxicity similar to that attributed to the tricyclic antidepressants. Cyclobenzaprine is metabolized by the liver and has an enterohepatic circulation and half-life of several days.</p></div><div id="Cyclobenzaprine.Outcome_and_Management"><h3>Outcome and Management</h3><p>The minor <a class="def" href="/books/n/livertox/glossary/def-item/glossary.alanine-aminotransferase-alt-/">ALT</a> elevations associated with chronic cyclobenzaprine use are usually asymptomatic and transient. Any elevation of greater than 10 times the upper limit of normal or persistence of abnormalities greater than 5 times the upper limit of normal should lead to discontinuation. <a class="def" href="/books/n/livertox/glossary/def-item/glossary.rechallenge/">Rechallenge</a> is not recommended unless the agent is felt to be highly needed. There is no reason to suspect cross sensitivity to hepatic injury among the various muscle relaxant drugs.</p><p>Drug Class: <a href="/books/n/livertox/MuscleRelaxants/">Muscle Relaxants</a></p></div></div><div id="Cyclobenzaprine.PRODUCT_INFORMATION_Musc"><h2 id="_Cyclobenzaprine_PRODUCT_INFORMATION_Musc_">PRODUCT INFORMATION</h2><div id="Cyclobenzaprine.BPI" class="box"><p>
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</p><p>Cyclobenzaprine – Generic, Flexeril®</p><p>
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<b> DRUG CLASS</b>
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</p><p>Autonomic Agents: Muscle Relaxants, Central</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=cyclobenzaprine" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri"> COMPLETE LABELING</a>
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</p><p>Product labeling at DailyMed, National Library of Medicine, NIH</p></div></div><div id="Cyclobenzaprine.CHEMICAL_FORMULA_AND_STR"><h2 id="_Cyclobenzaprine_CHEMICAL_FORMULA_AND_STR_">CHEMICAL FORMULA AND STRUCTURE</h2><div id="Cyclobenzaprine.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548894/table/Cyclobenzaprine.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Cyclobenzaprine.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Cyclobenzaprine.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Cyclobenzaprine.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NO</th><th id="hd_h_Cyclobenzaprine.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Cyclobenzaprine.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Cyclobenzaprine.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Cyclobenzaprine</td><td headers="hd_h_Cyclobenzaprine.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/134973614" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">303-53-7</a>
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</td><td headers="hd_h_Cyclobenzaprine.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">C20-H21-N</td><td headers="hd_h_Cyclobenzaprine.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">
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<div class="graphic"><img src="/books/NBK548894/bin/Cyclobenzaprine_Structure.jpg" alt="Cyclobenzaprine chemical structure" /></div>
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</td></tr></tbody></table></div></div></div><div id="Cyclobenzaprine.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Cyclobenzaprine_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 30 January 2017</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Cyclobenzaprine.R1">Zimmerman HJ. Muscle spasmolytics. In, Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver. 2nd Ed. Philadelphia: Lippincott, 1999. p. 544-45.<div><i>(Expert review of hepatotoxicity published in 1999 discusses dantrolene, chlorzoxazone and baclofen but does not mention cyclobenzapine).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R2">Hibbs RE, Zambon AC. Agents acting at the neuromuscular junction and autonomic ganglia. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman’s The pharmacological basis of therapeutics, 12th ed. New York: McGraw-Hill, 2011. p. 255-76.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R3">Katz WA, Dube J. Cyclobenzaprine in the treatment of acute muscle spasm: review of a decade of clinical experience. Clin Ther 1988; 10: 216-28. [<a href="https://pubmed.ncbi.nlm.nih.gov/3078905" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3078905</span></a>]<div><i>(Thorough review of pre- and postmarketing studies of efficacy and safety of cyclobenzaprine; "Routine laboratory measurements...obtained at the start and end of each study showed no alterations indicative of organ toxicity").</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R4">Winchell GA, King JD, Chavez-Eng CM, Constanzer ML, Korn SH. Cyclobenzaprine pharmacokinetics, including the effects of age, gender, and hepatic insufficiency. J Clin Pharmacol 2002; 42: 61-9. [<a href="https://pubmed.ncbi.nlm.nih.gov/11808825" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11808825</span></a>]<div><i>(Four studies from sponsor showing linear pharmacokinetics, slight accumulation, greater accumulation in liver disease, but no serious adverse events or liver toxicity).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R5">Spiller HA, Cutino L. Fatal cyclobenzaprine overdose with postmortem values. J Forensic Sci 2003; 48: 883-4. [<a href="https://pubmed.ncbi.nlm.nih.gov/12877312" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12877312</span></a>]<div><i>(Two patients with intentional cyclobenzaprine overdose died of respiratory arrest; one had chronic hepatitis C).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R6">Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage 2004; 28: 140-75. [<a href="https://pubmed.ncbi.nlm.nih.gov/15276195" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15276195</span></a>]<div><i>(Thorough review of the pharmacology, efficacy and side effects of the muscle relaxants).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R7">Toth PP, Urtis J. Commonly used muscle relaxant therapies for acute low back pain: a review of carisoprodol, cyclobenzaprine hydrochloride, and metaxalone. Clin Ther 2004; 26: 1355-67. [<a href="https://pubmed.ncbi.nlm.nih.gov/15530999" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15530999</span></a>]<div><i>(A review of safety and efficacy of muscle relaxants including cyclobenzaprine states that its common side effects include somnolence, dry mouth, fatigue, and headache; no mention of liver injury or ALT elevations).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R8">Russo MW, Galanko JA, Shrestha R, Fried MW, Watkins P. Liver transplantation for acute liver failure from drug-induced liver injury in the United States. Liver Transpl 2004; 10: 1018-23. <em>(Among</em>. [<a href="https://pubmed.ncbi.nlm.nih.gov/15390328" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15390328</span></a>]<div><i>~50,000 liver transplants done in the United States between 1990 and 2002, 270 [0.5%] were done for drug induced acute liver failure, but none were attributed to a specific muscle relaxant).</i></div></div></li><li><div class="bk_ref" id="Cyclobenzaprine.R9">Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-1352.e7. [<a href="/pmc/articles/PMC4446235/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4446235</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/25754159" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25754159</span></a>]<div><i>(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 5 [0.7%] were attributed to muscle relaxants, but none specifically to cyclobenzaprine).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div>
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<a href="https://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=pubmed&pubmedfilters=true&term=Cyclobenzaprine/AE+AND+Human%5BMH%5D+AND+(drug-induced+liver+injury+OR+jaundice/CI+OR+bile+duct+diseases/CI+OR+liver/DE+OR+liver+diseases/CI+OR+hepatitis,+toxic%5BMH%5D)+AND+(%222009/12/01/1%22%5BEDat%5D%3A%222999/12/31%22%5BEDat%5D)" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Recent References on Cyclobenzaprine: from PubMed.gov</a>
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<a href="https://clinicaltrials.gov/ct2/results?term=Cyclobenzaprine" ref="pagearea=document-links&targetsite=external&targetcat=link&targettype=uri">Trials on Cyclobenzaprine: from ClinicalTrials.gov</a>
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Epub 2022 Jan 6.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/16846511" ref="ordinalpos=1&linkpos=2&log$=relatedarticles&logdbfrom=pubmed">Rhabdomyolysis: a manifestation of cyclobenzaprine toxicity.</a><span class="source">[J Occup Med Toxicol. 2006]</span><div class="brieflinkpop offscreen_noflow">Rhabdomyolysis: a manifestation of cyclobenzaprine toxicity.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Chabria SB. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">J Occup Med Toxicol. 2006 Jul 17; 1:16. Epub 2006 Jul 17.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/26797071" ref="ordinalpos=1&linkpos=3&log$=relatedarticles&logdbfrom=pubmed">Painful Ejaculation with Cyclobenzaprine: A Case Report and Literature Review.</a><span class="source">[Sex Med. 2015]</span><div class="brieflinkpop offscreen_noflow">Painful Ejaculation with Cyclobenzaprine: A Case Report and Literature Review.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Kraus MB, Wie CS, Gorlin AW, Wisenbaugh ES, Rosenfeld DM. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Sex Med. 2015 Dec; 3(4):343-5. Epub 2015 Oct 19.</em></div></div></li><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/15956237" ref="ordinalpos=1&linkpos=4&log$=relatedreviews&logdbfrom=pubmed"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Effect of cyclobenzaprine on tricyclic antidepressant assays.</a><span class="source">[Ann Pharmacother. 2005]</span><div class="brieflinkpop offscreen_noflow"><span xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="invert">Review</span> Effect of cyclobenzaprine on tricyclic antidepressant assays.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Van Hoey NM. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">Ann Pharmacother. 2005 Jul-Aug; 39(7-8):1314-7. 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