EVALUATION OF DRUG USE IN HEPATITIS AND ASSOCIATED ADVERSE DRUG REACTIONS IN PEDIATRIC PATIENTS: A PROSPECTIVE OBSERVATIONAL STUDY.

Background: Hepatitis in children is managed with antivirals, immunomodulators, and supportive therapies, all of which may cause adverse drug reactions (ADRs). Data on pediatric ADRs remain limited in India. Objective: To evaluate the frequency, severity, onset, and causality of ADRs in pediatric hepatitis patients receiving direct-acting antivirals (DAAs), interferon, and supportive treatments at KGMU, Lucknow. Methods: A prospective observational study was conducted from March 2024 to March 2025 in Pediatrics and Medicine OPD/IPD at KGMU. Sixty-two children (ages 1–18 years) diagnosed with hepatitis A, B, C, or autoimmune hepatitis were monitored for ADRs. Reactions were assessed using the WHO-UMC causality scale and Hartwig’s severity scale. Results: ADRs were reported in 14 patients (22.6% incidence). The most common ADRs included diarrhea (35.7%), fever (21.4%), abdominal pain (14.3%), fatigue (14.3%), itching (7.1%), and weight gain with hyperglycemia (7.1%). Most ADRs were mild (Level 1), while diarrhea was rated moderate (Level 2). Causality assessment showed 92.9% as possible and 7.1% as probable. Interferon-based regimens were associated with earlier onset of ADRs compared to DAAs. Conclusion: ADRs were observed in about 25% of pediatric hepatitis patients, mainly as gastrointestinal symptoms. Most were mild, but some required management. DAAs showed a better safety profile than interferon-based treatments, emphasizing the need for routine monitoring and stronger pharmacovigilance in pediatric hepatology.