title: Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients.
abstract: BACKGROUND
  Tuberculosis has been one of the common diseases of human communities. Besides of disease-related complications, there are serious adverse reactions due to Anti-tuberculosis (Anti-TB) drug therapy.
  
  
  OBJECTIVE
  To assess the rate of Adverse Drug Reactions (ADRs) induced by Anti-TB drugs in the infectious disease department for a period of one year. To detect serious and preventable recognized ADRs.
  
  
  METHODS
  All patients admitted to the infectious disease department at Imam tertiary teaching hospital in Iran who received Anti-TB drugs from July 2001 to July 2002 entered the study. These patients were monitored for ADRs during hospital stay. The ADRs were then classified based on patients and reactions factors. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.
  
  
  RESULTS
  During the study period, 83 patients received Anti-TB drugs; of them 44 developed at least one ADR. Total number of 81 ADRs was detected in this study. ADRs were recognized as the major cause of hospital admission in 11 (13.3%) patients. The most frequent system-organ class affected by ADRs was Liver and biliary system (37%). Hepatitis was observed in 21 (25.3%) patients leading to death in two patients.
  
  
  CONCLUSIONS
  Anti-TB drugs could cause significant adverse effects both in quantity and severity leading to hospitalization, prolonged hospital stay and even death. More attention is needed to prevent these reactions.
authors.affiliation: Associate Professor & Chair Dept. of Clinical Pharmacy. Faculty of pharmacy. Tehran University of Medical Sciences . Tehran, Iran.
authors.forename: Kheirollah
authors.initials: K
authors.lastname: Gholami
authors.affiliation: Iranian Adverse Drug Reaction Monitoring Center Undersecretary of Food and Drug Affairs. Ministry of Health. Tehran, Iran .
authors.forename: Elahe
authors.initials: E
authors.lastname: Kamali
authors.affiliation: Associate Professor & Chair, Imam Khomeini hospital, Infectious disease department. Tehran University of Medical Sciences . Tehran, Iran .
authors.forename: Mahboubeh
authors.initials: M
authors.lastname: Hajiabdolbaghi
authors.affiliation: MPH, Iranian Adverse Drug Reaction Monitoring Center Undersecretary of Food and Drug Affairs.Ministry of Health. Tehran, Iran.
authors.forename: Gloria
authors.initials: G
authors.lastname: Shalviri
keywords: Adverse Drug Reaction Reporting Systems; Drug Toxicity; Inpatients; Iran; Tuberculosis