Pharmacovigilance Evaluation of Amoxicillin Induced Adverse Drug Reactions

Amoxicillin- Clavulanate is frequently prescribed to manage a wide range of bacterial infections in both outpatient and hospital setting. Although it is considered effective and reliable, its use may be associated with adverse drug reaction (ADRs). This review evaluates published studies and pharmacovigilance data to identify the nature, occurrence rate, severity, and causality of ADRs related to this medication. Reported reaction were systematically categorized according to the organ system involved, and their association with the drug was assessed using established causality assessment methods. The analysis indicates that gastrointestinal disturbances, including diarrhea, nausea, and abdominal discomfort, are the most commonly observed reactions. Uncommon but clinically significant reaction such as hepatotoxicity and serious hypersensitivity reactions have also been reported. Appropriate prescribing practices and patient monitoring are necessary to enhance safety and reduce the adverse outcome.