Tehran University of Medical Sciences Journal of Pharmaceutical Care 2322-4630 10 4 2022 12 31 234 236 Ali Soochi Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical sciences, Islamic Azad University, Tehran, Iran. Ramin Abrishami Department of Clinical Pharmacy, Faculty of Pharmacy, Pharmaceutical Sciences Branch, Islamic Azad University, Tehran.Iran AND Research Center for Trauma in Police Operations, Directorate of Health, Rescue & Treatment, Police Headquarter, Tehran, Iran Amir Nouroozi Iran Armed Forces Health Insurance Organization, Tehran, Iran. Dariush Taleei Medicinal Plants Research Center, Shahed University, Tehran Iran. 2022 07 13 2022 10 22 Background: Many medications are unlicensed for use in toddlers and many drugs are prescribed as off-label in this age group. Different studies showed high prevalence of prescribing such medications in children. Prescribing off-labeled or unlicensed drugs can cause adverse drug events (ADEs) and harm to the patients. To evaluate the rate of off-label and unlicensed drugs prescribed for toddlers.  Methods: Out-patient prescriptions within the electronic database from a main governmental health insurance company in Tehran, Iran were evaluated for off-label and unlicensed drugs in a two-month period (November-December 2019).  Results: 5358 prescriptions for toddlers reached to the insurance database, of these, 461 prescriptions were randomly selected. Three hundred and fifty prescriptions contained antibiotics and/or respiratory medications, from them, 183 (52.3%) had at least one off-labeled or unlicensed medication.  Conclusion: Our study showed high rates of off-label and/or unlicensed medication use in pediatric population. https://jpc.tums.ac.ir/index.php/jpc/article/view/511