Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar

Jayendra R. Gohil, Aniket B. Sarwade, Hardik R. Chauhan, Jay R. Jasani, Hinal R. Gujrati


Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.

Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.

Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.

Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.


Adverse drug reaction, Adverse drug event, Children, Naranjo scale, Pharmacovigilance

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