title: Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India.
abstract: OBJECTIVE
  To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period.
  
  
  METHODS
  A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI).
  
  
  RESULTS
  A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin+ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR's were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention.
  
  
  CONCLUSIONS
  The current study suggest that ADRs due to antimicrobials is a significant health problem.
authors.forename: V R
authors.initials: VR
authors.lastname: Tandon
authors.affiliation: Department of Biotechnology, Arni University, Indora, Himachal Pradesh, India.
authors.forename: S
authors.initials: S
authors.lastname: Sharma
authors.forename: V
authors.initials: V
authors.lastname: Khajuria
authors.forename: V
authors.initials: V
authors.lastname: Mahajan
authors.forename: Z
authors.initials: Z
authors.lastname: Gillani
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003430:Cross-Sectional Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D015995:Prevalence; D012189:Retrospective Studies; D062606:Tertiary Care Centers
chemical_list: D000900:Anti-Bacterial Agents