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Adverse Drug Reaction to First-Line Oral Antitubercular Drugs: An 8-Year Analysis from a Tertiary Centre in Eastern

Ratikanta Tripathy1, Pratima Singh2, Debasis Behera2

  • 1Deparment of Pharmacology, KIMS, KIIT, Bhubaneswar, Odisha, India.

The Nigerian Postgraduate Medical Journal
|January 2, 2026
PubMed
Abstract

Insights

Adverse drug reactions (ADRs) are common with anti-tuberculosis (TB) treatment. Drug-induced liver injury (DILI) was the most frequent ADR reported, highlighting the need for vigilant monitoring and reporting.

Area of Science:

  • Pharmacovigilance
  • Infectious Diseases
  • Clinical Pharmacology

Background:

  • Tuberculosis (TB) treatment relies on first-line anti-tubercular drugs.
  • Fixed-dose combinations are associated with various adverse drug reactions (ADRs).
  • Common ADRs include drug-induced liver injury (DILI), myalgia, arthralgia, hearing loss, and gastrointestinal issues.

Purpose of the Study:

  • To analyze the spectrum and severity of ADRs in TB patients.
  • To specifically focus on drug-induced liver injury (DILI) as a significant ADR.

Main Methods:

  • Retrospective study conducted between 2015 and 2023.
  • Inclusion of 108 patients from a tertiary care teaching hospital.
  • Classification of ADRs using WHO systems organ classes and seriousness criteria; DILI severity graded.

Main Results:

  • A total of 126 ADRs were documented.
  • Drug-induced liver injury (DILI) was the most frequently reported ADR.
  • Vomiting and itching were also commonly reported ADRs.

Conclusions:

  • Findings aim to improve clinicians' understanding of anti-TB treatment ADRs.
  • Emphasizes the importance of patient counseling and safety prioritization.
  • Encourages active reporting of all ADRs, including mild reactions.
Keywords:
Adverse drug reactionsHRZE and drug-induced liver injurydrug sensitive-tuberculosis

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