title: Propacetamol poses a potential harm of adverse hypotension in male and older patients.
abstract: OBJECTIVE
  Researchers recently suggested intravenous paracetamol as a potential cause of hypotension. We aimed to investigate risk factors of paracetamol- and propacetamol-associated adverse drug reactions (ADRs) in Korean individuals.
  
  
  METHODS
  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.
  
  
  RESULTS
  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-associated 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-associated ADR. Propacetamol/paracetamol-associated hypotension was frequently recorded in older patients (≥54 years) (53.9 ± 25.8 vs. 42.8 ± 21.7, P < 0.001) and taking more concomitant drugs (1.9 ± 5.0 vs. 1.1 ± 3.2, P < 0.001). Also, compared with other ADRs associated by propacetamol/paracetamol, hypotension was more commonly assessed as a serious outcome (27.3% vs. 11.4%, P < 0.001). 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).
  
  
  CONCLUSIONS
  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 © 2017 John Wiley & Sons, Ltd.
authors.affiliation: Department of Statistics, Clinical Trial Center, Ajou University Medical Center, Korea.
authors.forename: Hyun-Young
authors.initials: HY
authors.lastname: Lee
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Korea.|Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Ga-Young
authors.initials: GY
authors.lastname: Ban
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Korea.|Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Chang-Gyu
authors.initials: CG
authors.lastname: Jeong
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Korea.|Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Ji-Ho
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Seung-Hee
authors.initials: SH
authors.lastname: Park
authors.affiliation: Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Sang-Hee
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Young-Hee
authors.initials: YH
authors.lastname: Lee
authors.affiliation: Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Korea.|Regional Pharmacovigilance Center, Ajou University Medical Center, Suwon, Korea.
authors.forename: Young-Min
authors.initials: YM
authors.lastname: Ye
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007022:Hypotension / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea / Q000453:epidemiology; D012307:Risk Factors; D012737:Sex Factors
chemical_list: D000700:Analgesics; D000082:Acetaminophen; C063776:propacetamol
keywords: adverse drug reaction; hypotension; paracetamol; pharmacoepidemiology; propacetamol