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Safety analysis of 0.01% atropine sulfate eye drops in myopia prevention and control among children and adolescents
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Yin-ling ZHOU1a, Lu-sheng WANG1a, Meng-jie ZHOU1a, Shan LIN1b, Fang-fang XU1b, Jian-li PAN1a, Xiao-bi ZHANG1b
Chinese Journal of Clinical Pharmacology | 2026, 42(11) : 1586 - 1589
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Chinese Journal of Clinical Pharmacology | 2026, 42(11): 1586-1589
• Adverse Drug Reactions •
Safety analysis of 0.01% atropine sulfate eye drops in myopia prevention and control among children and adolescents
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Yin-ling ZHOU1a, Lu-sheng WANG1a, Meng-jie ZHOU1a, Shan LIN1b, Fang-fang XU1b, Jian-li PAN1a, Xiao-bi ZHANG1b
Affiliations
  • 1a.Department of Pharmacy, Wenzhou Medical University, Wenzhou 325027, Zhejiang Province, China
  • 1b.National Clinical Research Center for Ocular Diseases and Eye Hospital, Wenzhou Medical University, Wenzhou 325027, Zhejiang Province, China
Published: 2026-06-17 doi: 10.13699/j.cnki.1001-6821.2026.11.014
Outline
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Objective

To analyze the adverse drug reactions (ADRs) of 0.01% atropine sulfate eye drops in myopia control among children and adolescents, providing safety evidence for its clinical application.

Methods

Retrospective analysis of ADR data from pediatric and adolescent patients using the 0.01% atropine sulfate eye drops (hospital-prepared formulation) in our institution from January 2022 to December 2024.

Results

A total of 51 ADR cases were collected, with an incidence rate of 0.29%. Visual disorders were the most frequent (54.71%), primarily manifesting as eye pain, blurred vision, and photophobia; followed by skin and subcutaneous tissue disorders (11.76%), mainly presenting as rash; and nervous system disorders (9.80%), including dizzinessand headache. Newly reported ADRs accounted for 35 cases (68.63% of total reports). All ADRs were mild or moderate, with no severe cases observed.

Conclusion

0.01% atropine sulfate eye drops show favorable short-term safety and a low incidence of adverse drug reactions in myopia control among children and adolescents. As a real-world pharmacovigilance data report, this study provides certain cautions for the clinical use of 0.01% atropine sulfate eye drops; however, its long-term safety requires further investigation and validation.

0.01% atropine sulfate eye drop  /  myopia prevention and control  /  children and adolescent  /  adverse drug reaction
Yin-ling ZHOU, Lu-sheng WANG, Meng-jie ZHOU, Shan LIN, Fang-fang XU, Jian-li PAN, Xiao-bi ZHANG. Safety analysis of 0.01% atropine sulfate eye drops in myopia prevention and control among children and adolescents[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (11) : 1586 -1589 . DOI: 10.13699/j.cnki.1001-6821.2026.11.014
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Year 2026 volume 42 Issue 11
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.11.014
  • Receive Date：2025-12-15
  • Online Date：2026-08-06
  • Published：2026-06-17
Article Data
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History
  • Received：2025-12-15
Affiliations
    1a.Department of Pharmacy, Wenzhou Medical University, Wenzhou 325027, Zhejiang Province, China
    1b.National Clinical Research Center for Ocular Diseases and Eye Hospital, Wenzhou Medical University, Wenzhou 325027, Zhejiang Province, China
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