Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data
Abstract 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 (202...
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| Language: | English |
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Nature Portfolio
2025-07-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-025-08739-z |
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| author | Mohammed A. Aljallal Mishal I. Alhumaid Fai A. Alkathiri |
| author_facet | Mohammed A. Aljallal Mishal I. Alhumaid Fai A. Alkathiri |
| author_sort | Mohammed A. Aljallal |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-1ecae104ac884a3fa221f2a467b669f6 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-1ecae104ac884a3fa221f2a467b669f62025-08-20T03:45:48ZengNature PortfolioScientific Reports2045-23222025-07-0115111110.1038/s41598-025-08739-zEvaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance dataMohammed A. Aljallal0Mishal I. Alhumaid1Fai A. Alkathiri2Saudi Food and Drug AuthoritySaudi Food and Drug AuthorityDepartment of Pharmaceutics, College of Pharmacy, King Saud UniversityAbstract 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.https://doi.org/10.1038/s41598-025-08739-zCosmeticsReportsSide effectsSafetyCosmovigilance |
| spellingShingle | Mohammed A. Aljallal Mishal I. Alhumaid Fai A. Alkathiri Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data Scientific Reports Cosmetics Reports Side effects Safety Cosmovigilance |
| title | Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data |
| title_full | Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data |
| title_fullStr | Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data |
| title_full_unstemmed | Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data |
| title_short | Evaluating reporting trends and adverse effects of cosmetic products in Saudi Arabia based on SFDA cosmovigilance data |
| title_sort | evaluating reporting trends and adverse effects of cosmetic products in saudi arabia based on sfda cosmovigilance data |
| topic | Cosmetics Reports Side effects Safety Cosmovigilance |
| url | https://doi.org/10.1038/s41598-025-08739-z |
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