(A-263) A Two-Year Review of Adverse Drug Events (ADEs) in Saudi Arabia: Trends and Pharmacovigilance Insights from 2023-2024

Background: Adverse Drug Events (ADEs) are a key concern in medication safety, requiring continuous monitoring and regulatory action. The Saudi Food and Drug Authority (SFDA), through its National Pharmacovigilance Center, collects and analyzes ADE data to enhance public health protection. This study provides a comprehensive review of ADE reports that identify reporting trends, commonly implicated drugs, ADE severity, and regional contributions.

Objectives: Analyzing ADE reporting trends
Identify the frequently reported ADEs and associated medications
Assessing the severity and demographics of ADEs
Evaluating regional contributions to ADE reporting

Methods: A retrospective, descriptive analysis was conducted using ADE reports collected via the National Pharmacovigilance Center’s Spontaneous Vigilance System from January 1, 2023, to December 31, 2024. Data sources included reports from public and private hospitals, MOH, MOD, King Faisal Specialist Hospital & Research Centre (KFSHRC), Johns Hopkins Aramco Healthcare (JHAH), and university hospitals. Parameters analyzed include drug names, ADE types, severity classification (serious vs. non-serious), gender distribution, and regional reporting rates.

Results: A total of 198,117 ADE reports were recorded in 2023, increasing significantly to 370,536 in 2024. The severity distribution showed a decline in serious cases from 12% in 2023 to 1% in 2024, with non-serious cases comprising 99% of reports. Gender distribution remained consistent, with 53% of reports from males and 46% from females in 2023, shifting slightly to 54% male and 45% female in 2024. The most commonly reported ADEs were headache (38,817 cases), dizziness (19,608 cases), constipation (19,406 cases), nausea (17,140 cases), and abdominal pain (13,097 cases). The most frequently reported drugs included Amlodipine (10,051 reports), Atorvastatin (5,528 reports), Metformin (4,732 reports), Furosemide (4,182 reports), and Esomeprazole (3,839 reports). Regional contributions to ADE reporting were highest in Makkah (25.7%), Asir (25.4%), and the Eastern Region (21%), followed by Riyadh (11.4%) and Madinah (6.3%).

Conclusions: The data from 2023-2024 highlight the increasing trend in ADE reporting, with a notable 99% of cases classified as non-serious. The most frequently reported ADEs were headache, dizziness, constipation, nausea, and abdominal pain, linked primarily to Amlodipine, Atorvastatin, and Metformin. The Makkah and Asir regions contributed the highest percentage of ADE reports. These findings reinforce the need for continuous pharmacovigilance, improved reporting mechanisms, and targeted risk mitigation strategies to ensure medication safety in Saudi Arabia.