title: An analysis of adverse drug reactions to radiographic contrast media reported during a 3 year period in a tertiary care hospital in south India.
abstract: OBJECTIVE
  The aim of this study was to analyse the nature and incidence of adverse drug reactions to radiographic contrast media (ionic and non ionic) reported during a 3 year period in a tertiary care hospital in South India
  
  
  METHODS
  Adverse Drug Reactions (ADRs) to radiographic contrast media (ionic and non ionic) reported during a 3 year period to the pharmacovigilance centre, JIPMER, Pondicherry were retrospectively analysed for demographic profile, frequency, severity, causality and the temporal relationship of contrast administratior to the occurrence of ADR.
  
  
  RESULTS
  A total of 99 ADRs were spontaneously reported from 63 patients. It included 38 (60.3%) males and 25 (39.7%) females. The most common ADRs were nausea 26 (26.5%), vomiting 33 (33.7%) and rashes 30 (30.6%). As per Naranjo's algorithm and WHO causality assessment, all reactions were 'probable' According to the Hartwig severity scale, 60 reactions were mild (60.6%), 34 (34.3%) were moderate and 5 (5.1%) were severe. There was no fatality reported. Adverse events required treatment in 38 (60.3%) patients Most of the reactions (n = 48, 76.2%) occurred immediately after contrast administration. Five (7.9%) reactions occurred during contrast administration and 10 (15.9%) reactions occurred within the next 30 minutes after contrast administration. Among the ADRs reported, the proportion of mild reactions were significantly higher in patients who received ionic contrast (n = 42) than those who received non-ionic contrast (n = 21) (p < 0.05).
  
  
  CONCLUSIONS
  The common adverse reactions to contrast were nausea, vomiting and rashes. Most of the reactions occur immediately after administration of contrast and are of milder severity.
authors.forename: A
authors.initials: A
authors.lastname: Subathra
authors.forename: S
authors.initials: S
authors.lastname: Sandhiya
authors.forename: R
authors.initials: R
authors.lastname: Kesavan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003287:Contrast Media / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D062606:Tertiary Care Centers
chemical_list: D003287:Contrast Media