The Adverse Effects Reporting of Antibiotic Induced Diarrhea

Abstract

Introduction: In Saudi Food and Drug Authority, there is a center called National Pharmacovigilance and Drug Safety Center responsible for adverse events reporting. This study aims to demonstrate the antibiotic induced diarrhea reporting by National Pharmacovigilance and Drug Safety Center in Saudi Arabia. Methodology: This is a retrospective study about the reporting of diarrhea adverse effects caused by antibiotics. The data were collected from the adverse effects reports that were submitted to Saudi Food and Drug Authority in 2017 and 2018. Results: Gastrointestinal adverse effects reports were mainly for penicillin antibiotics. The major gastrointestinal adverse effect of penicillin was diarrhea (100 reports out of 147 reports for penicillin include diarrhea). Most of the diarrhea reports were caused by Amoxicillin/Clavulanate followed by Amoxicillin. Conclusion: One of the major adverse effects for antibiotics is diarrhea that is mainly occurred by penicillin antibiotics. The majority of cases of antibiotics-associated diarrhea are not serious, but still affect the patients’ quality of life. Therefore, it is important to increase the awareness regarding medications adverse effects and their reporting.