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<p>This retrospective observational study aimed to assess category-specific side effect reporting trends for cosmetic products in the Saudi Arabian market. A total of 1714 reports were analyzed from the Saudi Food and Drug Authority’s (SFDA) Cosmovigilance Database over a four-year period (2020–2023). The analysis showed that 53.32% of reports were submitted by males consumer. Phone-based reporting was the most common method (51.16%), followed by submissions through the official vigilance system (45.80%). Reporting activity increased steadily over the years, reflecting enhanced consumer awareness and engagement. Skincare products were the most frequently implicated category, with sensitivity (12.00%) and redness (4.00%) being the top reported adverse effects. Violations were primarily associated with heavy metals and bacterial contamination. The study emphasizes the vital role of the SFDA’s cosmovigilance system in maintaining public health and supports continued efforts to promote safe cosmetic.</p>

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Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月22日

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  • Mohammed A. Aljallal,
  • Mishal I. Alhumaid,
  • Fai A. Alkathiri

摘要

This retrospective observational study aimed to assess category-specific side effect reporting trends for cosmetic products in the Saudi Arabian market. A total of 1714 reports were analyzed from the Saudi Food and Drug Authority’s (SFDA) Cosmovigilance Database over a four-year period (2020–2023). The analysis showed that 53.32% of reports were submitted by males consumer. Phone-based reporting was the most common method (51.16%), followed by submissions through the official vigilance system (45.80%). Reporting activity increased steadily over the years, reflecting enhanced consumer awareness and engagement. Skincare products were the most frequently implicated category, with sensitivity (12.00%) and redness (4.00%) being the top reported adverse effects. Violations were primarily associated with heavy metals and bacterial contamination. The study emphasizes the vital role of the SFDA’s cosmovigilance system in maintaining public health and supports continued efforts to promote safe cosmetic.