Incidence and pattern of adverse drug reactions among pediatric inpatients: A prospective observational study.

Duggi Chandra  Sekhar; SOVS Satish  Reddy; Rajasekhar  Reddy T

doi:10.51168/sjhrafrica.v6i6.2005

Authors

Dr.Duggi Chandra Sekhar Assistant Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India
Dr. SOVS Satish Reddy Assistant Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India
Dr. Rajasekhar Reddy T Associate Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India

DOI:

https://doi.org/10.51168/sjhrafrica.v6i6.2005

Keywords:

Adverse drug reactions, Pediatrics, Pharmacovigilance, Drug safety, Antibiotics, Causality assessment

Abstract

Background:
Adverse drug reactions (ADRs) are a significant cause of morbidity in the pediatric population due to age-specific pharmacodynamic and pharmacokinetic variations. Active surveillance is crucial to understanding the pattern and burden of ADRs in this vulnerable group.

Objectives:

To determine the incidence, spectrum, causality, and severity of adverse drug reactions in pediatric patients at a tertiary care hospital.

Methods:

A prospective observational study was conducted over 12 months (March 2024–February 2025) in the Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh. A total of 100 inpatients aged <12 years were enrolled and monitored daily for suspected ADRs, which were documented and analyzed. Severity was graded using the Modified Hartwig and Siegel Scale, and causality was assessed by WHO-UMC criteria.

Results:

Out of 100 children, 26 (26%) experienced at least one ADR, accounting for 35 reactions. Infants aged <1 year showed the highest incidence (30%), with a slight male predominance. Antibiotics (48.6%) were the most frequently implicated drug class, followed by antiepileptics (20%) and NSAIDs (14.3%). Gastrointestinal (31.4%) and dermatological (25.7%) systems were most affected. Most ADRs were mild (65.7%), while 28.6% were moderate and 5.7% severe. According to WHO-UMC criteria, 40% were classified as possible, 37.1% as probable, and 22.9% as certain.

Conclusion:

A significant proportion of pediatric inpatients experienced ADRs, predominantly associated with antibiotics and antiepileptics. Most were mild to moderate and resolved without sequelae. The study underscores the importance of proactive monitoring and reporting systems to improve pediatric medication safety.

Recommendations:

Routine pharmacovigilance training and electronic monitoring should be integrated into pediatric care to reduce preventable adverse drug events.

Author Biographies

Dr.Duggi Chandra Sekhar, Assistant Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India

is a committed pediatrician and academician with comprehensive clinical and teaching experience. He completed his MBBS from Siddhartha Medical College, Vijayawada, Andhra Pradesh, and earned his DNB in Pediatrics from Ekta Institute of Child Health, Raipur, Chhattisgarh.

Dr. Sekhar has served as a Senior Resident at Government Medical College, Anantapur, and at Santhiram Medical College, Nandyal, for one year each. He is currently working as an Assistant Professor in the Department of Pediatrics at Santhiram Medical College, Nandyal, Andhra Pradesh, where he has been actively engaged in teaching and clinical services for over three years.

His research interests include pediatric infectious diseases, neonatology, and clinical diagnostics. He has published in peer-reviewed journals, including his recent article titled "Correlation of urine culture with urine microscopy, leucocyte esterase and dipstick nitrite in detection of urinary tract infection" in the Romanian Journal of Pediatrics (Ro J Pediatr. 2025;74(2)).ORCID ID: https://orcid.org/0009-0008-2697-1936

Dr. SOVS Satish Reddy, Assistant Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India

is currently working as an Assistant Professor in the Department of Pediatrics at Santhiram Medical College, Nandyal, Andhra Pradesh, India. He completed his MBBS from Sri Venkateswara Government Medical College, Tirupati, and obtained his Diplomate of National Board (DNB) in Pediatrics from the National Board of Examinations, New Delhi.

Dr. Reddy gained valuable clinical experience during his senior residency at Kurnool Government Medical College and Vishwabharathi Medical College. His professional interests include pediatric neurodevelopment, sleep disorders, and the effects of environmental and behavioral factors on child health.

He has contributed to academic research and is the author of the article titled "Impact of screen time on language development and sleep patterns in children: An observational cohort study", published in the Asian Journal of Medical Sciences (March 2025; Vol. 16, Issue 3).ORCID ID: https://orcid.org/0009-0003-4307-8406

Dr. Rajasekhar Reddy T, Associate Professor, Department of Pediatrics, Santhiram Medical College, Nandyal, Andhra Pradesh, India

is currently serving as an Associate Professor in the Department of Pediatrics at Santhiram Medical College, Nandyal, Andhra Pradesh, India. He earned his MBBS from Katuri Medical College, Guntur, under Dr. NTR University of Health Sciences, Vijayawada, in 2010, followed by his MD in Pediatrics from Aarupadai Veedu Medical College, Pondicherry, affiliated with Vinayaka Mission University, Tamil Nadu, in 2014.

Dr. Reddy has over 8 years of teaching experience, having previously held academic positions at KIMS, Narketpally, before joining Santhiram Medical College in 2020. He was promoted to Associate Professor in June 2022. Throughout his academic tenure, he has been actively engaged in undergraduate and postgraduate medical education, pediatric clinical services, and research.

His primary interests include pediatric infectious diseases, neonatal care, and pharmacovigilance in children. He has mentored numerous student research projects and clinical audits, contributing to safer pediatric prescribing and improved patient outcomes. ORCID ID: https://orcid.org/0009-0003-4342-7020

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