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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Dipyrone - Drugs and Lactation Database (LactMed®) - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]">
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<meta name="citation_title" content="Dipyrone">
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<meta name="citation_publisher" content="National Institute of Child Health and Human Development">
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<meta name="citation_date" content="2024/09/15">
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<meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK501526/">
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<meta name="citation_keywords" content="dipyrone">
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<meta name="citation_keywords" content="Analgin">
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<meta name="citation_keywords" content="Metamizole sodium">
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<meta name="citation_keywords" content="Methampyrone">
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<meta name="citation_keywords" content="Novalgin">
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<meta name="citation_keywords" content="sulpyrine">
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<meta name="citation_keywords" content="Metamizole">
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<meta name="citation_keywords" content="Methylmelubrin">
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<meta name="citation_keywords" content="Neomelurbrin">
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<meta name="citation_keywords" content="Algocalmin">
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<meta name="citation_keywords" content="Novalgetol">
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<meta name="citation_keywords" content="Metamizol">
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<meta name="citation_keywords" content="Optalgin">
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<meta name="citation_keywords" content="Pyralgin">
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<meta name="citation_keywords" content="Sulpyrin">
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<meta name="citation_keywords" content="Narone">
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<meta name="citation_keywords" content="Novamidazophen">
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<meta name="citation_keywords" content="Novaminsulfone">
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<meta name="citation_keywords" content="Algopyrine">
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<meta name="citation_keywords" content="Farmolisina">
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<meta name="citation_keywords" content="Metamizolum">
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<meta name="citation_keywords" content="Nevralgina">
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<meta name="citation_keywords" content="Pharmalgine">
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<meta name="citation_keywords" content="Alginodia">
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<meta name="citation_keywords" content="Dimethone">
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<meta name="citation_keywords" content="Diprofarn">
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<meta name="citation_keywords" content="Keypyrone">
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<meta name="citation_keywords" content="Metapyrin">
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<meta name="citation_keywords" content="Analgine">
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<meta name="citation_keywords" content="Bonpyrin">
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<meta name="citation_keywords" content="Feverall">
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<meta name="citation_keywords" content="Noveltex">
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<meta name="citation_keywords" content="Paralgin">
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<meta name="citation_keywords" content="Fevonil">
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<meta name="citation_keywords" content="Gifaril">
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<meta name="citation_keywords" content="Metilon">
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<meta name="citation_keywords" content="Pyretin">
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<meta name="citation_keywords" content="Pyrojec">
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<meta name="citation_keywords" content="Barone">
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<meta name="citation_keywords" content="Conmel">
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<meta name="citation_keywords" content="Sulpin">
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<meta name="citation_keywords" content="Neo-melubrine">
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<meta name="citation_keywords" content="Novaminsulfonum">
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<meta name="citation_keywords" content="Novaminsulfon">
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<meta name="citation_keywords" content="Sulpyrinum">
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<meta name="citation_keywords" content="Analginum">
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<meta name="citation_keywords" content="Di-podil">
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<meta name="citation_keywords" content="Metamizolnatrium">
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<meta name="citation_keywords" content="Novaminsulfonium">
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<meta name="citation_keywords" content="Novaminophenazone">
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<meta name="citation_keywords" content="Metamizolo">
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<meta name="citation_keywords" content="Novamidazophenum">
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<meta name="citation_keywords" content="Metamizole sodique">
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<meta name="citation_keywords" content="Metamizolum natricum">
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<meta name="citation_keywords" content="Noraminophenazone">
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<meta name="citation_keywords" content="Prodolina">
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<meta name="citation_keywords" content="ARPF">
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<meta name="citation_keywords" content="Metamizol sodico">
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<meta name="citation_keywords" content="Novaminsulfone sodium">
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<meta name="citation_keywords" content="Metamizolo sodico">
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<meta name="citation_keywords" content="Dipyrone [BAN]">
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<meta name="citation_keywords" content="Metamizolo [Italian]">
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<meta name="citation_keywords" content="Methamizole sodium">
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<meta name="citation_keywords" content="Aminopyrine sodium sulfonate">
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<meta name="citation_keywords" content="Sodium novaminsulfonate">
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<meta name="citation_keywords" content="Pyretin (pharmaceutical)">
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<meta name="citation_keywords" content="Natrium novaminsulfonicum">
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<meta name="citation_keywords" content="Metamizolo sodico [DCIT]">
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<meta name="citation_keywords" content="UNII-VSU62Z74ON">
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<meta name="citation_keywords" content="CCRIS 4443">
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<meta name="citation_keywords" content="EINECS 200-694-7">
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<meta name="citation_keywords" content="Noramidopyrinium-methanesulphate natrium [German]">
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<meta name="citation_keywords" content="Fenildimetil-pirazolon-metilaminometansolfonato sodico [Italian]">
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<meta name="citation_keywords" content="1-Phenyl-2,3-dimethyl-4-methylamino-5-pyrazolon-N-methanesulfonsaeuren natrium [German]">
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<meta name="citation_keywords" content="sodium">
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<meta name="citation_keywords" content="[(1,5-dimethyl-3-oxo-2-phenylpyrazol-4-yl)-methylamino]methanesulfonate">
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<meta name="DC.Title" content="Dipyrone">
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<meta name="DC.Type" content="Text">
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<meta name="DC.Publisher" content="National Institute of Child Health and Human Development">
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<meta name="DC.Date" content="2024/09/15">
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<meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK501526/">
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<meta name="description" content="After ingestion by the mother, dipyrone and its metabolites appear in breastmilk in rather large amounts. It is found in the blood and urine of breastfed infants and can cause pharmacological effects in the breastfed infant. One case of cyanotic episodes in a breastfed infant was attributed to dipyrone in breastmilk. The drug and metabolites are eliminated from the breastmilk by 48 hours after a dose.">
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<meta name="og:title" content="Dipyrone">
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<meta name="og:description" content="After ingestion by the mother, dipyrone and its metabolites appear in breastmilk in rather large amounts. It is found in the blood and urine of breastfed infants and can cause pharmacological effects in the breastfed infant. One case of cyanotic episodes in a breastfed infant was attributed to dipyrone in breastmilk. The drug and metabolites are eliminated from the breastmilk by 48 hours after a dose.">
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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="_NBK501526_"><span class="title" itemprop="name">Dipyrone</span></h1><p class="fm-aai"><a href="#_NBK501526_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 4 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 68-89-3</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/134971374" 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=134971374" alt="image 134971374 in the ncbi pubchem database" /></a><div id="LM635.Drug_Levels_and_Effects"><h2 id="_LM635_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM635.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>After ingestion by the mother, dipyrone and its metabolites appear in breastmilk in rather large amounts. It is found in the blood and urine of breastfed infants and can cause pharmacological effects in the breastfed infant. One case of cyanotic episodes in a breastfed infant was attributed to dipyrone in breastmilk. The drug and metabolites are eliminated from the breastmilk by 48 hours after a dose.</p><p>Dipyrone is not approved for marketing in the United States by the U.S. Food and Drug Administration nor in Canada and many European countries because of its adverse reactions, including agranulocytosis. However, it is widely used in other countries during labor and breastfeeding.[<a class="bibr" href="#LM635.REF.1" rid="LM635.REF.1">1</a>-<a class="bibr" href="#LM635.REF.4" rid="LM635.REF.4">4</a>] The European Medicines Agency recommends that dipyrone not be used in nursing mothers; however, several drug consultation centers in Israel disagree.[<a class="bibr" href="#LM635.REF.5" rid="LM635.REF.5">5</a>,<a class="bibr" href="#LM635.REF.6" rid="LM635.REF.6">6</a>] One manufacturer recommends to withhold breastfeeding for 48 hours after a dose.[<a class="bibr" href="#LM635.REF.7" rid="LM635.REF.7">7</a>] Safer alternatives are available for analgesia during breastfeeding.</p></div><div id="LM635.Drug_Levels"><h3>Drug Levels</h3><p><i>Maternal Levels.</i> A woman took 3 doses of dipyrone 500 mg orally, over a 16-hour period. The dipyrone concentration in breastmilk was 4.3 mg/L 24 hours after the last dose.[<a class="bibr" href="#LM635.REF.8" rid="LM635.REF.8">8</a>]</p><p>Ten women who were 3 to 5 days postpartum were given a single dose of 1 gram of dipyrone orally. Milk concentrations of its four metabolites were measured in breastmilk. In 8 of the patients, milk samples were taken once between 2.5 to 5.5 hours after the dose; all 4 metabolites were detected in the milk of all mothers. The total concentration of all the metabolites averaged 20.5 mg/L at the times sampled. In 2 of the women, milk samples were obtained before drug administration and before each feeding for 3 days. By 48 hours after the dose all metabolites were absent from breastmilk.[<a class="bibr" href="#LM635.REF.9" rid="LM635.REF.9">9</a>] Using data from the 2 mothers with extensive sampling, an exclusively breastfed infant would receive an average of 6.8% of the maternal weight-adjusted dipyrone dosage in the form of metabolites.</p><p>In a survey of breastmilk in a rural Chilean hospital, dipyrone was detectable in the breastmilk of 8 out of 15 mothers tested.[<a class="bibr" href="#LM635.REF.1" rid="LM635.REF.1">1</a>]</p><p><i>Infant Levels.</i> Dipyrone was detected in a breastfed infant's serum and urine after his mother took 1500 mg of dipyrone over a 16-hour period. The infant's dipyrone serum concentration was 3.2 mg/L and urine concentration was 3.74 mg/L.[<a class="bibr" href="#LM635.REF.8" rid="LM635.REF.8">8</a>]</p></div><div id="LM635.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>A 42-day-old breastfed infant had 2 cyanotic episodes within 30 minutes after his mother took 3 doses of dipyrone 500 mg orally, 18, 7 and 2 hours before the first episode. A third episode occurred 24 hours after admission to the hospital. Dipyrone was detected in the mother's breastmilk 24 hours after the last dose and in the infant's serum and urine. No explanation could be found for the cyanotic episodes other than dipyrone and after suspending maternal dipyrone intake, no further episodes occurred in the infant up to age 3 years. The reaction is rated as possibly caused by dipyrone in breastmilk.[<a class="bibr" href="#LM635.REF.8" rid="LM635.REF.8">8</a>]</p><p>In a blinded study, mothers who were at least 3 days postpartum and requesting analgesia for postpartum uterine pain were given either 1 gram of dipyrone or placebo. The infants of mothers who received dipyrone cried fewer times and for shorter durations in the 14 hours after drug administration than the infants of mothers who received placebo. This effect was more apparent in infants who demand fed than in those who fed on a fixed schedule.[<a class="bibr" href="#LM635.REF.10" rid="LM635.REF.10">10</a>] Although this study appears to demonstrate a pharmacologic effect in the infants from dipyrone in milk, there is no clear explanation for the change in infant behavior.</p><p>A multicenter case-control study in Brazil compared 231 children who developed leukemia before 2 years of age with 411 children with various other nonmalignant diseases. Mothers were interviewed to ascertain their analgesic use during pregnancy and lactation. Nursing mothers who took dipyrone during the three months after delivery had a 2-fold risk of having a child with acute lymphocytic leukemia and a 3.87-fold risk in having rearrangement of the MLL gene in infants under one year of age.[<a class="bibr" href="#LM635.REF.11" rid="LM635.REF.11">11</a>]</p></div><div id="LM635.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM635.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p><a href="/books/n/lactmed/LM330/?report=reader">Acetaminophen</a>, <a href="/books/n/lactmed/LM142/?report=reader">Ibuprofen</a>, <a href="/books/n/lactmed/LM370/?report=reader">Morphine</a></p></div><div id="LM635.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM635.REF.1">Aquino
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R, Barrios
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C, Lobos
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C, et al.
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Measurement of nicotine, cotinine and caffeine by GC-NPD-MS in human breast milk samples of puerperals hospitalized in "Las Higueras", Talcahuano, Chile.
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Rev Toxicol
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2006;23:108-12.</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM635.REF.2">Sabo
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A, Stanulovic
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M, Jakovljevic
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V, et al.
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Collaborative study on drug use in pregnancy: The results of the follow-up 10 years after (Novi Sad Centre).
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Pharmacoepidemiol Drug Saf
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2001;10:229-35.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/11501336" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11501336</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM635.REF.3">A multicenter study of drug use during pregnancy in Spain (IV). The drugs used during lactation. The DUP working group Spain.
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Med Clin (Barc)
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1992;98:726-30.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/1608277" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 1608277</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM635.REF.4">Prakash
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O, Mathur
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GP, Kushwaha
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KP, et al.
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Drug exposure in pregnant and lactating mothers in periurban areas.
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Indian Pediatr
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1990;27:1301-2.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2093678" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2093678</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM635.REF.5">European Medicines Agency. EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding. 2018. <a href="https://www.ema.europa.eu/documents/press-release/ema-recommends-aligning-doses-metamizole-medicines-their-use-during-pregnancy-breastfeeding_en.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.ema.europa<wbr style="display:inline-block"></wbr>​.eu/documents/press-release<wbr style="display:inline-block"></wbr>​/ema-recommends-aligning-doses-metamizole-medicines-their-use-during-pregnancy-breastfeeding_en.pdf</a></div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM635.REF.6">Dinavitser
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N.
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Dipyrone-a good medication with a bad reputation.
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J Med Toxicol
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2020
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16:78. doi:10.1007/s13181-019-00743-w [<a href="http://dx.crossref.org/10.1007/s13181-019-00743-w" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM635.REF.7">Bar-Oz
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B, Bulkowstein
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M, Benyamini
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L, et al.
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Use of antibiotic and analgesic drugs during lactation.
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Drug Saf
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2003;26:925-35.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/14583068" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 14583068</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM635.REF.8">Rizzoni
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G, Furlanut
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M. Cyanotic crisis in a breast-fed infant from mother taking dipyrone.
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Hum Toxicol
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1984;3:505-7.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/6526398" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 6526398</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM635.REF.9">Zylber-Katz
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E, Linder
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N, Granit
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L, et al.
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Excretion of dipyrone metabolites in human breast milk.
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Eur J Clin Pharmacol
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1986;30:359-61.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3732376" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3732376</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="LM635.REF.10">Linder
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N, German
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B, Bessant
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D, et al.
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The pharmacological effect on term neonates of analgesic drugs ingested through maternal milk.
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Can J Clin Pharmacol
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1997;4:112-4.</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="LM635.REF.11">Couto
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AC, Ferreira
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JD, Pombo-de-Oliveira
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MS, et al.
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Pregnancy, maternal exposure to analgesic medicines, and leukemia in Brazilian children below 2 years of age.
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Eur J Cancer Prev
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2015;24:245-52.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/25121973" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25121973</span></a>]</div></dd></dl></dl></div></div><div id="LM635.Substance_Identification"><h2 id="_LM635_Substance_Identification_">Substance Identification</h2><div id="LM635.Substance_Name"><h3>Substance Name</h3><p>Dipyrone</p></div><div id="LM635.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>68-89-3</p></div><div id="LM635.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Analgesic Agents</p><p>Anti-inflammatory Agents, Nonsteroidal</p></div></div><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></dl></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK501526_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">September 15, 2024</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div></div><h3>Publisher</h3><p><a href="https://www.nlm.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Child Health and Human Development</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Dipyrone. [Updated 2024 Sep 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM1484/?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/lactmed/diroximel_fumarate/?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></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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