Codeine-containing over-the-counter (OTC) medicines are most commonly used in treating acute pain and work by binding codeine to opioid receptors in the central nervous system than leading to a reduction in pain sensation and reduced reactivity to it. The purpose of this paper is to analyze reports of suspected adverse reactions of codeine-containing OTC medicines received by the Croatian Agency for Medicinal Products and Medical Devices (HALMED) in the period from 2008 to 2021. There were 60 reports and 120 adverse reactions analyzed, and the results were processed according to: age and sex of the patient, applicant, share in total reports, severity, outcome, association, type of adverse reaction and adverse reactions placed in different organic systems that were classified by the Medical Dictionary for Regulatory Affairs (MedDRA). An analysis of concomitant and suspected active substances was also performed. The largest number of adverse reactions were reported by physicians, most of them related to females and the age group of 18 to 44 years. Most adverse reactions of codeinecontaining OTC medicines belonged to the System organic class (SOC) Psychiatric disorders, SOC Skin and subcutaneous tissue disorders and SOC Gastrointestinal disorders. Most common side effects were drug dependence, pruritus, somnolence and suicide attempt. The obtained data were compared with data from the European (EudraVigilance) and global (VigiAccess) database of adverse reactions, matches were observed to a large extent, but not completely. In some countries codeine-containing medicines are available only in prescription status because of its most common adverse reaction; drug dependence.