Analisis Reporting Odds Ratio Efek Samping Gastrointestinal pada Metformin Berdasarkan Data FAERS 2025
DOI:
https://doi.org/10.71282/jurmie.v3i2.1714Keywords:
metformin, FAERS, farmakovigilans, gastrointestinalAbstract
Latar Belakang: Metformin merupakan terapi lini pertama pada diabetes melitus tipe 2 dan diketahui memiliki efek samping gastrointestinal. Database FDA Adverse Event Reporting System (FAERS) dapat digunakan untuk mendeteksi sinyal farmakovigilans. Tujuan: Menganalisis hubungan antara penggunaan metformin dan kejadian efek samping gastrointestinal berdasarkan database FAERS. Metode: Studi observasional retrospektif menggunakan data FAERS kuartal pertama tahun 2025. Efek samping gastrointestinal didefinisikan sebagai laporan dengan Preferred Term (PT): nausea, vomiting, dan diarrhoea. Analisis dilakukan menggunakan metode disproporsionalitas melalui perhitungan Reporting Odds Ratio (ROR) dengan uji chi-square menggunakan aplikasi Uji Statistik. Hasil: Dari 2.008.162 laporan yang dianalisis, diperoleh nilai ROR sebesar 0,376 (IK95%: 0,371–0,382; p < 0,001). Kesimpulan: Terdapat hubungan signifikan antara metformin dan laporan efek samping gastrointestinal dalam database FAERS, dengan keterbatasan inheren sistem pelaporan spontan.
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Copyright (c) 2026 Annisa Abdi Ghifari (Author)
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