title: An observational study of cutaneous adverse drug reactions in a teaching hospital.
abstract: BACKGROUND
  Pharmacotherapy is often impeded by adverse drug reactions (ADRs). Among these ADRs cutaneous reactions are the major class being easily identified and reported. If not noted early it has potential to develop into serious lesions.
  
  
  OBJECTIVE
  To evaluate the clinical patterns of various drug induced cutaneous reactions. Setting A Teaching hospital in India. Methods All suspected cutaneous reactions to systemic drugs which were submitted to the ADR monitoring centre during a 6-month period (March 2014-August 2014) were analysed. Causality relationship, severity assessment and preventability assessment was also done.
  
  
  RESULTS
  Out of 134 cutaneous ADRs, 56 % occurred in females, majority of cases were found in the age group of 41-50 years. The most common type of ADR was maculopapular rash (46.3 %) and majorly implicated drug class was antibiotics (51.3 %). Most (72.3 %) were mild. Polypharmacy and multiple comorbid conditions were important predisposing factors. Over half of the cases (58 %) were not preventable.
  
  
  CONCLUSIONS
  Cutaneous adverse reaction patterns and their causes vary as the result of changing use of drugs. In India, antibiotics are responsible for the majority of the cutaneous adverse drug reactions, and maculopapular rash is the side effect that is most reported.
authors.affiliation: Department of Pharmacology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, 110062, India.
authors.forename: Deepti
authors.initials: D
authors.lastname: Chopra
authors.affiliation: DGHS, CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi, 110002, India.
authors.forename: Vibha
authors.initials: V
authors.lastname: Sharma
authors.affiliation: HIMSR, Jamia Hamdard, New Delhi, India.
authors.forename: Rohan
authors.initials: R
authors.lastname: Kapoor
authors.affiliation: Department of Medicine and Preventive Cardiology, Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, New Delhi, 110062, India. shridhar.dwivedi@gmail.com.
authors.forename: Shridhar
authors.initials: S
authors.lastname: Dwivedi
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D015984:Causality; D015897:Comorbidity; D003875:Drug Eruptions / Q000453:epidemiology / Q000473:pathology*; D016903:Drug Monitoring; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D010267:Parapsoriasis / Q000473:pathology; D019338:Polypharmacy; D012867:Skin / Q000473:pathology
chemical_list: D000900:Anti-Bacterial Agents
keywords: ADR; Causality; Cutaneous reactions India; Maculopapular rash; Pharmacovigilance India