BackgroundTafamidis　emerged　as　the　first　FDA-approved　drug　for　treating　termed　amyloid　fibrils.　This　study　aims　to　analyze　adverse　events　(AEs)　related　to　tafamidis　from　the　second　quarter　(Q2)　of　2019　to　the　fourth　quarter　(Q4)　of　2023　from　the　FDA　adverse　event　reporting　system　(FAERS)　database.Research　design　and　methodsThe　AE　data　related　to　tafamidis　from　2019　Q2　to　2023　Q4　were　collected　and　standardized.　Various　signal　quantification　techniques,　including　reporting　odds　ratio　(ROR),　proportional　reporting　ratio　(PRR),　Bayesian　confidence　propagation　neural　network,　and　multi-item　gamma　Poisson　shrinker,　were　employed　for　analysis.ResultsAmong　the　8742　AE　reports　with　tafamidis　as　the　primary　suspected　drug,　180　preferred　terms　of　AEs　spanning　27　different　system　organ　classes　were　identified.　Unique　adverse　events　to　tafamidis　included　renal　and　urinary　disorders　and　ear　and　labyrinth　disorders,　with　not　mentioned　in　the　official　drug　label.　Additionally,　uncommon　but　significantly　strong　AE　signals,　such　as　blood　culture　positive　and　acquired　hemophilia,　were　observed.　Common　AEs　with　relatively　high　occurrence　rates　included　death,　off-label　use,　fall,　hypoacusis,　and　dysphagia.ConclusionThese　findings　offer　valuable　insights　for　optimizing　the　use　of　tafamidis　and　reducing　potential　side　effects,　thereby　facilitating　its　safe　use　in　clinical　settings.