Adverse drug reactions in paediatric patients in a tertiary care hospital in India: a prospective observational single centre study

T. V. S. Divyalasya, Vasundara Krishnaiah, H. T. Yashoda, Pundarikaksha H. P., B. L. Kudagi, Ramamohan Pathapati


Background: Adverse drug reactions (ADRs) are a major source of concern in adult and paediatric population. Monitoring ADRs in children is vital as they differ from adults in pharmacokinetic and pharmacodynamics responses. Strict ethical guidelines in clinical trials result in extrapolation of data from studies done in adults. Further, ADRs reported in adults do not predict those in children. Incidence of ADRs in children is 2.9% emphasizing the need for systematic monitoring. Studies at institutional level can generate valuable data among paediatric population. Hence, the current study was taken up to assess the clinical pattern of ADRs, their causality, severity and preventability.

Methods: This is a prospective observational single centre study. Suspected cases of ADRs were collected and assessed for the clinical pattern, causality, severity and preventability factors along with gender-wise distribution.

Results: A total of 118 ADRs were reported in our study. Most of the ADRs (46.67%) occurred below 1 year of age with male preponderance (53.4%). Skin was the most common organ involved (91.5%). Majority (78.8%) of ADRs were due to anti-infectives for systemic use (J). Vaccines were the most commonly implicated agents (55.9%) followed by antibiotics (22.9%). Severe reaction like DRESS syndrome was reported due to antiepileptics (including levetiracetam) requiring hospitalisation. Majority of ADRs were probable (92.4%), moderate (73.7%) and definitely preventable (61%).

Conclusions: A wide range of ADRs are possible in paediatric population. Adequate knowledge about ADRs is essential and caution has to be exercised even while prescribing drugs which are considered safe in children.


Antiepileptics, DRESS syndrome, Levetiracetam, Paediatrics, Pharmacovigilance, Vaccines

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