{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,2]],"date-time":"2025-05-02T15:28:54Z","timestamp":1746199734156},"reference-count":30,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,1,13]],"date-time":"2017-01-13T00:00:00Z","timestamp":1484265600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003569","name":"Ministry of Food and Drug Safety","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003569","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Researchers recently suggested intravenous paracetamol as a potential cause of hypotension. We aimed to investigate risk factors of paracetamol\u2010 and propacetamol\u2010associated adverse drug reactions (ADRs) in Korean individuals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All adverse hypotension cases, regardless of suspected drug, and all ADRs associated with paracetamol and propacetamol use were collected from the Korea Adverse Event Reporting System database between 2011 and 2014. The seriousness, causality, and type of ADR were classified.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 4,771 cases of adverse hypotension, 403 (8.4%) were reported to be related to propacetamol. This was comparable to the rate of hypotension associated with fentanyl (454, 9.5%), the major suspected drug of hypotension. Paracetamol\u2010associated hypotension accounted for merely 1.2% (55 cases) of all hypotension cases. Among ADRs associated with propacetamol use, hypotension was the most common (37.1%), whereas cutaneous reactions were the primary paracetamol\u2010associated ADR. Propacetamol\/paracetamol\u2010associated hypotension was frequently recorded in older patients (\u226554\u2009years) (53.9\u2009\u00b1\u200925.8 vs. 42.8\u2009\u00b1\u200921.7, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001) and taking more concomitant drugs (1.9\u2009\u00b1\u20095.0 vs. 1.1\u2009\u00b1\u20093.2, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Also, compared with other ADRs associated by propacetamol\/paracetamol, hypotension was more commonly assessed as a serious outcome (27.3% vs. 11.4%, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001). Regarding concomitant medications, the risk for hypotension associated with propacetamol was significantly increased in patients simultaneously taking antibacterials (J01), cold preparations (R05), drugs for acid related disorders (A02), blood substitutes (B05), or antithrombotics (B01).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Propacetamol was found to be a major suspected drug of pharmacologically associated hypotension in Korea. Older and male patients taking medications in combination with propacetamol\/paracetamol should undergo monitoring of their blood pressure. Copyright \u00a9 2017 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4159","type":"journal-article","created":{"date-parts":[[2017,1,13]],"date-time":"2017-01-13T15:55:28Z","timestamp":1484322928000},"page":"256-264","source":"Crossref","is-referenced-by-count":13,"title":["Propacetamol poses a potential harm of adverse hypotension in male and older patients"],"prefix":"10.1002","volume":"26","author":[{"given":"Hyun\u2010Young","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Statistics, Clinical Trial Center Ajou University Medical Center  Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ga\u2010Young","family":"Ban","sequence":"additional","affiliation":[{"name":"Department of Allergy and Clinical Immunology Ajou University School of Medicine  Korea"},{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang\u2010Gyu","family":"Jeong","sequence":"additional","affiliation":[{"name":"Department of Allergy and Clinical Immunology Ajou University School of Medicine  Korea"},{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji\u2010Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Allergy and Clinical Immunology Ajou University School of Medicine  Korea"},{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seung\u2010Hee","family":"Park","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang\u2010Hee","family":"Kim","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young\u2010Hee","family":"Lee","sequence":"additional","affiliation":[{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young\u2010Min","family":"Ye","sequence":"additional","affiliation":[{"name":"Department of Allergy and Clinical Immunology Ajou University School of Medicine  Korea"},{"name":"Regional Pharmacovigilance Center Ajou University Medical Center  Suwon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,1,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/170247"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10787-013-0172-x"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aer107"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annfar.2009.01.018"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0000000000000499"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ijnp\/pyu080"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.1996.01430170079015"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aes344"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12708"},{"key":"e_1_2_8_11_1","unstructured":"Reporting adverse drug reaction: definition of terms and criteria for their use. 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