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<meta name="citation_inbook_title" content="LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]">
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<meta name="citation_title" content="Baclofen">
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yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK548081_"><span class="title" itemprop="name">Baclofen</span></h1><p class="fm-aai"><a href="#_NBK548081_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Baclofen.OVERVIEW"><h2 id="_Baclofen_OVERVIEW_">OVERVIEW</h2><div id="Baclofen.Introduction"><h3>Introduction</h3><p>Baclofen is a centrally acting muscle relaxant commonly prescribed for spasticity in patients with multiple sclerosis. Baclofen has not been linked to rare instances of mild, self-limited, clinically apparent liver injury.</p></div><div id="Baclofen.Background"><h3>Background</h3><p>Baclofen (bak' loe fen) is a gamma-amino butyric acid (GABA) derivative that acts as an agonist of the GABA B receptor, thereby activating potassium channels and reducing calcium conductance leading to hypotonia and muscle relaxation. Baclofen acts primarily at the level of the spinal cord, inhibiting synaptic reflexes. Baclofen reduces the number and severity of muscle spasms and relieves pain, clonus and muscle rigidity due to spasticity. Baclofen is indicated primarily for treatment of spasticity from spinal cord injuries and multiple sclerosis. It has been used off label as adjunctive therapy to help with alcohol abstinence and withdrawal. Baclofen was approved for use in the United States in 1977 and is widely used with several million prescriptions filled yearly. Baclofen is available in various generic forms as well as under the brand names of Lioresal and Remular in tablets of 10 or 20 mg and in formulations for intrathecal injections of 0.5 mg/mL. The recommended adult dose for spasticity is 10 to 20 mg orally three to four times daily. The dose should be increased and tapered gradually. The most common side effects of baclofen are nausea, drowsiness, confusion, dizziness and fatigue.</p></div><div id="Baclofen.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>Limited data are available on the potential hepatotoxicity of baclofen. Among the many clinical trials evaluating the safety and efficacy of baclofen, none mentioned hepatic toxicity or rates of serum ALT elevations occurring during chronic therapy. The product insert starts that 5% of treated patients develop mild serum aminotransferase elevations, but little documentation is available on the significance, severity or duration of these abnormalities. A single case of mild and self-limited hepatitis attirbuted to baclofen has been published. The latency to onset was 3 months, the pattern of injury was hepatocellular, and recovery was rapid and complete, all laboratory tests being normal within a few weeks of stopping.</p><p>Likelihood score: D (Possible, rare cause of clinically apparent liver injury).</p></div><div id="Baclofen.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The apparent absence of significant hepatotoxicity from baclofen may be due to its minimal hepatic metabolism (~15%) and rapid urinary excretion.</p></div><div id="Baclofen.Outcome_and_Management"><h3>Outcome and Management</h3><p>The minor ALT elevations associated with chronic baclofen 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. Cases of clinically apparent liver injury have been self-limited in course and outcome and there have been no reports of acute liver failure, chronic hepatitis or vanishing bile duct syndrome associated with its use. There is no reason to suspect cross sensitivity to liver injury among the various muscle relaxants.</p><p>Drug Class: <a href="/books/n/livertox/MuscleRelaxants/?report=reader">Muscle Relaxants</a></p></div></div><div id="Baclofen.PRODUCT_INFORMATION"><h2 id="_Baclofen_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><div id="Baclofen.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Baclofen – Generic, Lioresal®</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=baclofen" 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="Baclofen.CHEMICAL_FORMULA_AND_STRUCTURE"><h2 id="_Baclofen_CHEMICAL_FORMULA_AND_STRUCTURE_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figBaclofenT1"><a href="/books/NBK548081/table/Baclofen.T1/?report=objectonly" target="object" title="Table" class="img_link icnblk_img" rid-ob="figobBaclofenT1"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="Baclofen.T1"><a href="/books/NBK548081/table/Baclofen.T1/?report=objectonly" target="object" rid-ob="figobBaclofenT1">Table</a></h4></div></div></div><div id="Baclofen.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Baclofen_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 30 January 2017</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Baclofen.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; mentions baclofen has been used for decades, but specific reports of hepatic injury are scanty).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R2">Hudgson P, Weightman D, Cartlidge NE. Clinical trial of baclofen against placebo. Postgrad Med J 1972; 48 (Suppl 5): 37-40.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/4585729" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 4585729</span></a>]<div><i>(23 patients treated with baclofen in a placebo controlled trial; central nervous system side effects discussed, but no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R3">Brogden RN, Speight TM, Avery GS. Baclofen: a preliminary report of its pharmacological properties and therapeutic efficacy in spasticity. Drugs 1974; 8: 1-14.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/4154834" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 4154834</span></a>]<div><i>(Review of preliminary studies of baclofen including side effects; does not mention ALT abnormalities or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R4">Cartlidge NE, Hudgson P, Weightman D. A comparison of baclofen and diazepam in the treatment of spasticity. J Neurol Sci 1974; 23: 17-24.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/4850175" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 4850175</span></a>]<div><i>(Controlled trial in 49 patients discusses central nervous system side effects, but does not mention ALT abnormalities or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R5">Basmajian JV. Lioresal(baclofen) treatment of spasticity in multiple sclerosis. Am J Phys Med 1975; 54: 175-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/1098477" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 1098477</span></a>]<div><i>(Double-blind cross over trial of placebo vs baclofen for 4 weeks; no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R6">From A, Heltberg A. A double-blind trial with baclofen (Lioresal) and diazepam in spasticity due to multiple sclerosis. Acta Neurol Scand 1975; 51: 158-66.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/1090103" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 1090103</span></a>]<div><i>(Double-blind cross over trial in 17 patients; major side effect was sedation; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R7">Duncan GW, Shahani BT, Young RR. An evaluation of baclofen treatment for certain symptoms in patients with spinal cord lesions. A double-blind, cross-over study. Neurology 1976; 26: 441-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/772461" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 772461</span></a>]<div><i>(Double-blind cross over study in 22 patients; no mention of ALT monitoring or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R8">Milla PJ, Jackson AD. A controlled trial of baclofen in children with cerebral palsy. J Int Med Res 1977; 5: 398-404.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/338390" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 338390</span></a>]<div><i>(Cross over study of baclofen vs placebo in 20 children; no mention of ALT monitoring or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R9">Sachais BA, Logue JN, Carey MS. Baclofen, a new antispastic drug. A controlled, multicenter trial in patients with multiple sclerosis. Arch Neurol 1977; 34: 422-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/327987" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 327987</span></a>]<div><i>(106 patients given baclofen or placebo for 5 weeks; no laboratory abnormalities found and no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R10">Feldman RG, Kelly-Hayes M, Conomy JP, Foley JM. Baclofen for spasticity in multiple sclerosis. Double-blind cross-over and three-year study. Neurology 1978; 28: 1094-8.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/362234" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 362234</span></a>]<div><i>(23 patients in a 10 week cross over trial and then given baclofen for 3 years; laboratory tests taken every 3 months showed no abnormality and results make no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R11">Ghose K, Holmes KM, Matthewson K. Complications of baclofen overdosage. Postgrad Med J 1980; 56: 865-7.
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[<a href="/pmc/articles/PMC2424842/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2424842</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/7267501" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 7267501</span></a>]<div><i>(Overdose of baclofen led to coma and respiratory failure, but no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R12">Lipscomb DJ, Meredith TJ. Baclofen overdose. Postgrad Med J 1980; 56: 108-9.
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[<a href="/pmc/articles/PMC2425514/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2425514</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/6771749" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 6771749</span></a>]<div><i>(Overdose of baclofen led to coma and respiratory failure, but no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R13">Smolenski C, Muff S, Smolenski-Kautz S. A double-blind comparative trial of new muscle relaxant, tizanidine (DS 103-282), and baclofen in the treatment of chronic spasticity in multiple sclerosis. Curr Med Res Opin 1981; 7: 374-83.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/7016449" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 7016449</span></a>]<div><i>(21 patients were treated with tizanidine or baclofen for 6 weeks; authors make no mention of hepatotoxicity of either drug).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R14">Chui LK, Pelot D. Hepatic enzyme elevations associated with baclofen. Clin Pharm 1984; 3: 196-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/6723229" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 6723229</span></a>]<div><i>(Manufacturer reported than <1% of patients on baclofen developed AST elevations, but no case of overt hepatitis was reported; one patient with traumatic quadriplegia and spasticity developed ALT elevations [414 U/L] after 6 weeks of escalating doses of baclofen [80 mg/day] without symptoms or jaundice, which fell to normal with decrease in dose).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R15">Dapas F, Hartman SF, Martinez L, et al. Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo. Spine 1985; 10: 345-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2931831" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2931831</span></a>]<div><i>(Placebo controlled trial in 200 patients, 98 on baclofen for 6 weeks; no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R16">Garabedian-Ruffalo SM, Ruffalo RL. Adverse effects secondary to baclofen withdrawal. Drug Intell Clin Pharm 1985; 19: 304-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/4006720" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 4006720</span></a>]<div><i>(40 year old woman with multiple sclerosis developed spasms and acute psychosis within days of switching from baclofen to amitriptyline; no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R17">Hulme A, MacLennan WJ, Ritchie RT, John VA, Shotton PA. Baclofen in the elderly stroke patient its side-effects and pharmacokinetics. Eur J Clin Pharmacol 1985; 29: 467-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3912190" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3912190</span></a>]<div><i>(12 elderly patients given baclofen had higher drug levels and more problems with drowsiness, but no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R18">Roussan M, Terrence C, Fromm G. Baclofen versus diazepam for the treatment of spasticity and long-term follow-up of baclofen therapy. Pharmatherapeutica 1985; 4: 278-84.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3906673" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3906673</span></a>]<div><i>(18 patients were treated with baclofen for 4 years; authors make no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R19">Stien R, Nordal HJ, Oftedal SI, Sletteb M. The treatment of spasticity in multiple sclerosis: a double-blind clinical trial of a new anti-spastic drug tizanidine compared with baclofen. Acta Neurol Scand 1987; 75: 190-4.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3554879" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3554879</span></a>]<div><i>(40 patients given either tizanidine or baclofen for 6 weeks, no changes observed in laboratory tests of liver function or mention made of hepatotoxicity of either drug).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R20">Bass B, Weinshenker B, Rice GP, et al. Tizanidine versus baclofen in the treatment of spasticity in patients with multiple sclerosis. Can J Neurol Sci 1988; 15: 15-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3345456" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3345456</span></a>]<div><i>(Double-blind cross over study of tizanidine vs baclofen for 5 weeks each and routine laboratory monitoring found no alterations in biochemical test results with either agent).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R21">Hoogstraten MC, van der Ploeg RJ, vd Burg W, Vreeling A, van Marle S, Minderhoud JM. Tizanidine versus baclofen in the treatment of spasticity in multiple sclerosis patients. Acta Neurol Scand 1988; 77: 224-30.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3376747" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3376747</span></a>]<div><i>(16 patients treated with tizanidine and baclofen in a cross over study; muscle weakness was more common with baclofen; no mention of laboratory tests or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R22">Nance PW. A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients. J Am Paraplegia Soc 1994; 17: 150-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/7964712" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 7964712</span></a>]<div><i>(No mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R23">Chen KS, Bullard MJ, Chien YY, Lee SY. Baclofen toxicity in patients with severely impaired renal function. Ann Pharmacother 1997; 31: 1315-20.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/9391686" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9391686</span></a>]<div><i>(Total of 16 instances of baclofen toxicity with depressed consciousness in patients on renal dialysis; no mention of hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R24">Groves L, Shellenberger MK, Davis CS. Tizanidine treatment of spasticity: a meta-analysis of controlled, double-blind, comparative studies with baclofen and diazepam. Adv Ther 1998; 15: 241-51.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10186943" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10186943</span></a>]<div><i>(Metaanalysis of 10 trials in 270 patients comparing baclofen and tizanidine reported global tolerance, but no mention made of ALT abnormalities or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R25">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.
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[<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="Baclofen.R26">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. (Among
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. [<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 US 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="Baclofen.R27">Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924-34.
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[<a href="/pmc/articles/PMC3654244/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3654244</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/18955056" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18955056</span></a>]<div><i>(Among 300 cases of drug induced liver disease in the US collected from 2004 to 2008, one was attributed to chlorzoxazone, but none to baclofen).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R28">Caruso A, Vecchio R, Patti F, Neri S. Drug rash with eosinophilia and systemic signs syndrome in a patient with multiple sclerosis. Clinical Therapeutics 2009; 31: 580-4.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/19393848" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19393848</span></a>]<div><i>(44 year old woman developed drug rash, eosinophilia and jaundice 8 weeks after starting baclofen, mitoxantrone, and piracetam [bilirubin 19.3 mg/dL, ALT 561 U/L, Alk P 705 U/L], resolving within 6 months of stopping; causality assessment implicated mitoxantrone [a toposiomerase inhibitor used to treat multiple sclerosis]).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R29">Addolorato G, Leggio L. Safety and efficacy of baclofen in the treatment of alcohol-dependent patients. Curr Pharm Des 2010; 16: 2113-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/20482507" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20482507</span></a>]<div><i>(Review of trials of baclofen for alcohol withdrawal and dependence; in large numbers of patients with chronic alcoholism and some with significant alcoholic liver disease, baclofen "did not produce any serious or severe side effects").</i></div></div></li><li><div class="bk_ref" id="Baclofen.R30">Reuben A, Koch DG, Lee WM; Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010; 52: 2065-76.
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[<a href="/pmc/articles/PMC3992250/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3992250</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20949552" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20949552</span></a>]<div><i>(Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, none of which were attributed to baclofen or other muscle relaxants).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R31">Garbutt JC, Kampov-Polevoy AB, Gallop R, Kalka-Juhl L, Flannery BA. Efficacy and safety of baclofen for alcohol dependence: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res 2010; 34: 1849-57.
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[<a href="/pmc/articles/PMC2965272/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC2965272</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/20662805" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20662805</span></a>]<div><i>(Controlled trial of 12 weeks of baclofen vs placebo in 80 patients with alcohol dependence reported that adverse events were "relatively mild"; no mention of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R32">Heydtmann M. Baclofen effect related to liver damage. Alcohol Clin Exp Res 2011; 35: 848.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/21303383" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21303383</span></a>]<div><i>(Letter in response to Garbutt [2010] describing baclofen treatment of 50 patients with alcohol dependence found that those with advanced liver disease responded to lower doses than those with normal liver function).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R33">Macaigne G, Champagnon N, Harnois F, Cheiab S, Chayette C. Baclofen-induced acute hepatitis in alcohol-dependent patient. Clin Res Hepatol Gastroenterol 2011; 35: 420-1.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/21561828" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21561828</span></a>]<div><i>(46 year old woman with chronic alcoholism and abnormal serum enzymes had worsening of ALT [1.5 to 6.5 times ULN], AST [5.5 to 9 times ULN], with no change in bilirubin or Alk P 2 months after starting baclofen, improving on stopping).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R34">Brennan JL, Leung JG, Gagliardi JP, Rivelli SK, Muzyk AJ. Clinical effectiveness of baclofen for the treatment of alcohol dependence: a review. Clin Pharmacol 2013; 5: 99-107.
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[<a href="/pmc/articles/PMC3706258/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC3706258</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/23869179" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23869179</span></a>]<div><i> (Review of 4 randomized controlled trials of baclofen for alcohol dependence found that data in support of its efficacy were mixed, but that data were consistent regarding its safety; no discussion of ALT elevations or hepatotoxicity).</i></div></div></li><li><div class="bk_ref" id="Baclofen.R35">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.
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[<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 cases [0.7%] were attributed to muscle relaxants, one of which due to baclofen).</i></div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548081_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">January 30, 2017</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a></div></div><h3>Publisher</h3><p><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>, Bethesda (MD)</p><h3>NLM Citation</h3><p>LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Baclofen. [Updated 2017 Jan 30].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/BaJiaoLian/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/livertox/Bacopa/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="boxed-text" id="figobBaclofenBPI"><div id="Baclofen.BPI" class="box boxed-text-box whole_rhythm hide-overflow"><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Baclofen – Generic, Lioresal®</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=baclofen" 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></article><article data-type="table-wrap" id="figobBaclofenT1"><div id="Baclofen.T1" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548081/table/Baclofen.T1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Baclofen.T1_lrgtbl__"><table><thead><tr><th id="hd_h_Baclofen.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">DRUG</th><th id="hd_h_Baclofen.T1_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">CAS REGISTRY NO</th><th id="hd_h_Baclofen.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Baclofen.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Baclofen.T1_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Baclofen</td><td headers="hd_h_Baclofen.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/134980970" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">1134-47-0</a>
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</td><td headers="hd_h_Baclofen.T1_1_1_1_3" rowspan="1" colspan="1" style="vertical-align:top;">C10-H12-Cl-N-O2</td><td headers="hd_h_Baclofen.T1_1_1_1_4" rowspan="1" colspan="1" style="vertical-align:top;">
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<div class="graphic"><img src="/books/NBK548081/bin/Baclofen_Structure.jpg" alt="Baclofen chemical structure" /></div>
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