Objectives To assess the extent of use, patterns, variables and Adverse Drug Reactions associated with off label prescribing in Pediatrics. Methods A prospective observational study was conducted for a period of 6 months for children of the age group 0‐17 years in a tertiary care Hospital in Maharashtra, India. Off label drug use was assessed using Micromedex and British National Formulary for Children (BNFC 2016–2017). Adverse Drug Reactions (ADRs) were assessed according to the physicians' notes, recorded during the patient's hospital stay. Pearson correlation coefficient was computed to assess the relationship between age and the number of off‐ label drugs. Odds ratio was calculated for the occurrence of ADRs in on‐label prescriptions Vs off label‐prescriptions. A P value of <0.05 was considered as significant. Key findings A total of 1514 prescriptions were evaluated in 300 patients. Out of which 542 (35.79%) and 423 (27.9%) were off label according to Micromedex and BNFC respectively. The number of patients who received at least one off label was found to be 225 (75%) – Micromedex and 223 (74.3%) – BNFC Unspecified indication and use of drugs outside the specified age limit were identified as the main variables associated with off label prescribing. Highest proportion of off‐label drugs was found in Alimentary system. A total of 35 ADRs (OR 6.92 CI 95%(OR 6.92, 95% CI, 3.13‐15.27)) were identified in 31 patients. Conclusions Off‐label drug use is prevalent in the pediatric population and warrants an evidence‐based approach to improve prescribing practices in pediatrics.

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