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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Pilocarpine - LiverTox - NCBI Bookshelf</title>
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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="Pilocarpine">
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<meta name="citation_publisher" content="National Institute of Diabetes and Digestive and Kidney Diseases">
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<meta name="citation_date" content="2020/06/24">
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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="_NBK548815_"><span class="title" itemprop="name">Pilocarpine</span></h1><p class="fm-aai"><a href="#_NBK548815_pubdet_">Publication Details</a></p></div></div><div class="body-content whole_rhythm" itemprop="text"><div id="Pilocarpine.OVERVIEW"><h2 id="_Pilocarpine_OVERVIEW_">OVERVIEW</h2><div id="Pilocarpine.Introduction"><h3>Introduction</h3><p>Pilocarpine is an orally available cholinergic agonist that is used to treat symptoms of dry mouth in patients with keratoconjunctivitis sicca (Sjögren syndrome) or with xerostomia (dry mouth) due to local irradiation. Pilocarpine has not been linked to serum enzyme elevations during therapy or to instances of clinically apparent liver injury.</p></div><div id="Pilocarpine.Background"><h3>Background</h3><p>Pilocarpine (pye" loe kar' peen) is a cholinergic agonist that stimulates muscarinic receptors, resulting in an increase in parasympathetic activity. Engagement of the cholinergic receptors causes increased secretion from exocrine glands, including sweat, salivary, lacrimal, gastric, pancreatic and intestinal glands, as well as increased tone and motility of smooth muscle cells in the eye, respiratory and gastrointestinal tract. Use of daily oral doses of pilocarpine has been shown to improve symptoms of dry mouth and increase salivary flow in patients with Sjögren syndrome and with xerostomia due to local irradiation therapy. Pilocarpine for oral use was approved for use in the United States in the 1990s and is currently available in generic forms as tablets of 5 mg. Pilocarpine is also available as ophthalmologic drops for therapy of glaucoma and ocular hypertension. The typical oral dose is 5 mg 2 to 4 times daily. Side effects are usually mild and largely attributable to cholinergic stimulation including increased sweating, rhinitis, nausea, diarrhea, headaches, dizziness, visual disturbances and fatigue.</p></div><div id="Pilocarpine.Hepatotoxicity"><h3>Hepatotoxicity</h3><p>In clinical trials of pilocarpine, serum enzyme elevations were uncommon and no more frequent than with placebo. Despite, wide scale use, there have been no published reports of acute liver injury attributable to pilocarpine.</p></div><div id="Pilocarpine.Mechanism_of_Injury"><h3>Mechanism of Injury</h3><p>The mechanism by which pilocarpine might cause serum aminotransferase elevations is not known. Pilocarpine is metabolized in parasympathetic synaptic clefts and in plasma and has little hepatic metabolism.</p><p>Drug Class: Sjögren Syndrome Agents, Cholinergic Agents</p><p>Other Drugs in the Class: <a href="/books/n/livertox/Cevimeline/?report=reader">Cevimeline</a></p></div></div><div id="Pilocarpine.PRODUCT_INFORMATION"><h2 id="_Pilocarpine_PRODUCT_INFORMATION_">PRODUCT INFORMATION</h2><p>
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<b>REPRESENTATIVE TRADE NAMES</b>
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</p><p>Pilocarpine – Generic</p><p>
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<b>DRUG CLASS</b>
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</p><p>Sjögren Syndrome Agents</p><p>
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<a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?label=all&query=Pilocarpine" 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 id="Pilocarpine.CHEMICAL_FORMULA_AND_STRUCTU"><h2 id="_Pilocarpine_CHEMICAL_FORMULA_AND_STRUCTU_">CHEMICAL FORMULA AND STRUCTURE</h2><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figPilocarpineTc"><a href="/books/NBK548815/table/Pilocarpine.Tc/?report=objectonly" target="object" title="Table" class="img_link icnblk_img figpopup" rid-figpopup="figPilocarpineTc" rid-ob="figobPilocarpineTc"><img class="small-thumb" src="/books/NBK548815/table/Pilocarpine.Tc/?report=thumb" src-large="/books/NBK548815/table/Pilocarpine.Tc/?report=previmg" alt="Image " /></a><div class="icnblk_cntnt"><h4 id="Pilocarpine.Tc"><a href="/books/NBK548815/table/Pilocarpine.Tc/?report=objectonly" target="object" rid-ob="figobPilocarpineTc">Table</a></h4></div></div></div><div id="Pilocarpine.ANNOTATED_BIBLIOGRAPHY"><h2 id="_Pilocarpine_ANNOTATED_BIBLIOGRAPHY_">ANNOTATED BIBLIOGRAPHY</h2><p>References updated: 24 June 2020</p><ul class="first-line-outdent"><li><div class="bk_ref" id="Pilocarpine.REF.zimmerman.1999">Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.<div><i>(Extensive review of hepatotoxicity published in 1999; cholinergic agents and pilocarpine are not discussed).</i></div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.kaplowitz.2013">Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013.<div><i>(Textbook of hepatotoxicity published in 2013; cholinergic agents and pilocarpine are not discussed).</i></div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.henderer.2018">Henderer JD, Rapuano CJ. Ocular pharmacology. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1251-70.<div><i>(Textbook of pharmacology and therapeutics).</i></div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.fox.1986.243">Fox PC, van der Ven PF, Baum BJ, Mandel ID. Pilocarpine for the treatment of xerostomia associated with salivary gland dysfunction. <span><span class="ref-journal">Oral Surg Oral Med Oral Pathol. </span>1986;<span class="ref-vol">61</span>:243–8.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/3517744" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3517744</span></a>]<div>
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<i>(Pilot study of single doses of pilocarpine or placebo in 6 patients with Sjögren syndrome demonstrated an increase in salivary flow and decrease in sensation of dry mouth).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.rieke.1995.661">Rieke JW, Hafermann MD, Johnson JT, LeVeque FG, Iwamoto R, Steiger BW, Muscoplat C, Gallagher SC. Oral pilocarpine for radiation-induced xerostomia: integrated efficacy and safety results from two prospective randomized clinical trials. <span><span class="ref-journal">Int J Radiat Oncol Biol Phys. </span>1995;<span class="ref-vol">31</span>:661–9.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/7852133" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 7852133</span></a>]<div>
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<i>(Among 369 patients with xerostomia following cancer radiotherapy who were treated with pilocarpine [2.5-10 mg every 8 hours] or placebo for 12 weeks, there were no serious drug related adverse events at any dose).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.vivino.1999.174">Vivino FB, Al-Hashimi I, Khan Z, LeVeque FG, Salisbury PL 3rd, Tran-Johnson TK, Muscoplat CC, et al. Pilocarpine tablets for the treatment of dry mouth and dry eye symptoms in patients with Sjögren syndrome: a randomized, placebo-controlled, fixed-dose, multicenter trial. P92-01 Study Group. <span><span class="ref-journal">Arch Intern Med. </span>1999;<span class="ref-vol">159</span>:174–81.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/9927101" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9927101</span></a>]<div>
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<i>(Among 373 patients with Sjögren syndrome who were treated with pilocarpine [2.5 or 5 mg 4 times daily] or placebo for 12 weeks, none had serious drug related adverse events; liver function tests were monitored, but there was no mention of ALT elevations or hepatotoxicity).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.wu.2006.796">Wu CH, Hsieh SC, Lee KL, Li KJ, Lu MC, Yu CL. Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjögren syndrome in Taiwan--a double-blind, placebo-controlled trial. <span><span class="ref-journal">J Formos Med Assoc. </span>2006;<span class="ref-vol">105</span>:796–803.</span> [<a href="/pmc/articles/PMC7134824/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7134824</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/17000452" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17000452</span></a>]<div>
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<i>(Among 44 patients with Sjögren syndrome treated with pilocarpine [5 mg 4 times daily] or placebo for 12 weeks, the most common side effect was excessive sweating [22%] and there were no serious adverse events or "significant alterations in ...hepatic profiles").</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.fox.2003.247">Fox RI. Sjogren's syndrome: evolving therapies. <span><span class="ref-journal">Expert Opin Investig Drugs. </span>2003;<span class="ref-vol">12</span>:247–54.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/12556218" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12556218</span></a>]<div>
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<i>(Review of standard and experimental therapies of Sjögren syndrome mentions pilocarpine and cevimeline, but does not discuss its adverse side effects).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.papas.2004.169">Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, et al. Successful treatment of dry mouth and dry eye symptoms in Sjögren syndrome patients with oral pilocarpine: a randomized, placebo-controlled, dose-adjustment study. <span><span class="ref-journal">J Clin Rheumatol. </span>2004;<span class="ref-vol">10</span>:169–77.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/17043506" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17043506</span></a>]<div>
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<i>(Among 250 patients with Sjögren syndrome treated with pilocarpine [20-30 mg daily] or placebo for 12 weeks, there were no serious drug related adverse events or significant changes in laboratory results in comparison to placebo).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.berk.2008.1333">Berk L. Systemic pilocarpine for treatment of xerostomia. <span><span class="ref-journal">Expert Opin Drug Metab Toxicol. </span>2008;<span class="ref-vol">4</span>:1333–40.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/18798702" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 18798702</span></a>]<div>
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<i>(Review of 6 controlled trials of pilocarpine for radiation induced xerostomia; among 261 patients treated long term, side effects included sweating [55%], urinary frequency [11%], rhinitis [10%], headache [8%], increased lacrimation [8%] and diarrhea [6%], with no mention of ALT elevations or clinically apparent liver injury).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.ramoscasals.2010.452">Ramos-Casals M, Tzioufas AG, Stone JH, Sisó Bosch X. Treatment of primary Sjögren syndrome: a systematic review. <span><span class="ref-journal">JAMA. </span>2010;<span class="ref-vol">304</span>:452–60.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/20664046" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20664046</span></a>]<div>
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<i>(Review of 3 controlled trials of pilocarpine in 673 patients with Sjögren syndrome found improvements in symptoms of dry mouth and dry eyes with a dose of 5 mg every 6 hours, but also a higher rate of excessive sweating, urinary frequency and nausea; no mention of ALT elevations or clinically apparent liver injury).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.reuben.2010.2065">Reuben A, Koch DG, Lee WM., Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. <span><span class="ref-journal">Hepatology. </span>2010;<span class="ref-vol">52</span>:2065–76.</span> [<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>
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<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, but none were linked to pilocarpine or other cholinergic agents).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.chalasani.2015.1340">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. <span><span class="ref-journal">Gastroenterology. </span>2015;<span class="ref-vol">148</span>:1340–1352.e7.</span> [<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>
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<i>(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, no cases were attributed to pilocarpine or other cholinergic agents).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.tanigawa.2015.164">Tanigawa T, Yamashita J, Sato T, Shinohara A, Shibata R, Ueda H, Sasaki H. Efficacy and safety of pilocarpine mouthwash in elderly patients with xerostomia. <span><span class="ref-journal">Spec Care Dentist. </span>2015;<span class="ref-vol">35</span>:164–9.</span> [<a href="https://pubmed.ncbi.nlm.nih.gov/25639487" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25639487</span></a>]<div>
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<i>(Among 40 elderly patients with dry mouth who were treated with pilocarpine or plain water mouthwash for 4 weeks, drop outs were frequent, and common side effects were oral or tongue discomfort, while xerostomia improved with the pilocarpine but not the water mouthwash).</i>
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</div></div></li><li><div class="bk_ref" id="Pilocarpine.REF.britozer_n.2019.e001064">Brito-Zerón P, Retamozo S, Kostov B, Baldini C, Bootsma H, De Vita S, Dörner T, et al. Efficacy and safety of topical and systemic medications: a systematic literature review informing the EULAR recommendations for the management of Sjögren's syndrome. <span><span class="ref-journal">RMD Open. </span>2019;<span class="ref-vol">5</span>:e001064. </span> [<a href="/pmc/articles/PMC6827762/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6827762</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31749986" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31749986</span></a>]<div>
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<i>(Systematic review of the literature on therapies for sicca syndrome mentions 5 controlled trials showing improvements in oral dryness and saliva flow with pilocarpine and cevimeline but no evidence for effects from trials of systemic treatments with anakinra, hydroxychloroquine, infliximab or rituximab).</i>
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</div></div></li></ul></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK548815_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Update: <span itemprop="dateModified">June 24, 2020</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-. Pilocarpine. [Updated 2020 Jun 24].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/livertox/PDE5Inhibitors/?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/Pimavanserin/?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="table-wrap" id="figobPilocarpineTc"><div id="Pilocarpine.Tc" class="table"><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK548815/table/Pilocarpine.Tc/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__Pilocarpine.Tc_lrgtbl__"><table><thead><tr><th id="hd_h_Pilocarpine.Tc_1_1_1_1" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">DRUG</th><th id="hd_h_Pilocarpine.Tc_1_1_1_2" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CAS REGISTRY NO.</th><th id="hd_h_Pilocarpine.Tc_1_1_1_3" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MOLECULAR FORMULA</th><th id="hd_h_Pilocarpine.Tc_1_1_1_4" scope="col" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">STRUCTURE</th></tr></thead><tbody><tr><td headers="hd_h_Pilocarpine.Tc_1_1_1_1" scope="row" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Pilocarpine</td><td headers="hd_h_Pilocarpine.Tc_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/134972029" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem">92-13-7</a>
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</td><td headers="hd_h_Pilocarpine.Tc_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">C11-H16-N2-O2</td><td headers="hd_h_Pilocarpine.Tc_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<a href="https://pubchem.ncbi.nlm.nih.gov/substance/134972029" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=134972029" alt="image 134972029 in the ncbi pubchem database" /></a>
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