title: Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions.
abstract: OBJECTIVE
  We analyzed differences between spontaneously reported drug-induced (not including contrast media) and contrast media-induced adverse reactions.
  
  
  METHODS
  Adverse drug reactions reported by an in-hospital pharmacovigilance center (St. Mary's teaching hospital, Daejeon, Korea) from 2010-2012 were classified as drug-induced or contrast media-induced. Clinical patterns, frequency, causality, severity, Schumock and Thornton's preventability, and type A/B reactions were recorded. The trends among causality tools measuring drug and contrast-induced adverse reactions were analyzed.
  
  
  RESULTS
  Of 1,335 reports, 636 drug-induced and contrast media-induced adverse reactions were identified. The prevalence of spontaneously reported adverse drug reaction-related admissions revealed a suspected adverse drug reaction-reporting rate of 20.9/100,000 (inpatient, 0.021%) and 3.9/100,000 (outpatients, 0.004%). The most common adverse drug reaction-associated drug classes included nervous system agents and anti-infectives. Dermatological and gastrointestinal adverse drug reactions were most frequently and similarly reported between drug and contrast media-induced adverse reactions. Compared to contrast media-induced adverse reactions, drug-induced adverse reactions were milder, more likely to be preventable (9.8% vs. 1.1%, p < 0.001), and more likely to be type A reactions (73.5% vs. 18.8%, p < 0.001). Females were over-represented among drug-induced adverse reactions (68.1%, p < 0.001) but not among contrast media-induced adverse reactions (56.6%, p = 0.066). Causality patterns differed between the two adverse reaction classes. The World Health Organization-Uppsala Monitoring Centre causality evaluation and Naranjo algorithm results significantly differed from those of the Korean algorithm version II (p < 0.001).
  
  
  CONCLUSIONS
  We found differences in sex, preventability, severity, and type A/B reactions between spontaneously reported drug and contrast media-induced adverse reactions. The World Health Organization-Uppsala Monitoring Centre and Naranjo algorithm causality evaluation afforded similar results.
authors.affiliation: Evidence-Based Research Laboratory, Department of Clinical Pharmacy and Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South Korea.|Department of Pharmacy, Division of Pharmacovigilance, Saint Mary's Hospital, Daejeon, South Korea.
authors.forename: JiHyeon
authors.initials: J
authors.lastname: Ryu
authors.affiliation: Evidence-Based Research Laboratory, Department of Clinical Pharmacy and Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South Korea.
authors.forename: HeeYoung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Department of Pharmaceutical Industry, ChungAng University, Seoul, South Korea.
authors.forename: JinUk
authors.initials: J
authors.lastname: Suh
authors.affiliation: Department of Pharmaceutical Industry, ChungAng University, Seoul, South Korea.
authors.forename: MyungSuk
authors.initials: M
authors.lastname: Yang
authors.affiliation: College of Pharmacy, Chung-Ang University, Seoul, South Korea.
authors.forename: WonKu
authors.initials: W
authors.lastname: Kang
authors.affiliation: Evidence-Based Research Laboratory, Department of Clinical Pharmacy and Pharmaceutical Care, College of Pharmacy, Chung-Ang University, Seoul, South Korea.|Department of Pharmaceutical Industry, ChungAng University, Seoul, South Korea.|College of Pharmacy, Chung-Ang University, Seoul, South Korea.
authors.forename: EunYoung
authors.initials: E
authors.lastname: Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology* / Q000517:prevention & control; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008490:Medical Informatics; D008875:Middle Aged; D060735:Pharmacovigilance; D055815:Young Adult
chemical_list: D003287:Contrast Media