Background Bufei Huoxue Capsule (BHC) has gradually been used in clinical practice to treat patients with pneumoconiosis in recent years. However, the comprehensive evaluation of its efficacy and safety is lacking. Objective To systematically assess the therapeutic potential of BHC for pneumoconiosis. Methods By searching 9 databases, e.g. China National Knowledge Infrastructure, Wanfang Database, VIP Chinese Science and Technology Journals Database, SinoMed, Yiigle, PubMed, Embase, Cochrane Library, and Web of Science, randomized controlled trials (RCTs) related to the use of BHC for the treatment of pneumoconiosis were identified. The search covered the period from the inception of these databases to August 31, 2025. This systematic review conformed to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) 2020. The included studies underwent quality appraisal by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Subgroup analysis and sensitivity analysis were applied to assess the robustness of results and explore the potential heterogeneity among the studies. Results A total of 19 RCTs were included and all were reported in Chinese. The therapy containing BHC showed a superior impact on forced expiratory volume in one second (FEV₁) (95%CI: 0.38, 0.66; I²=69%, P<0.05), FEV₁% (95%CI: 3.37, 5.72; I²=12%, P<0.05), forced vital capacity (FVC) (95%CI: 0.34, 0.45; I²=0%, P<0.05), FEV₁/FVC% (95%CI: 6.29, 10.35; I²=21%, P<0.05), 6-minute walking distance (6MWD) score (95%CI: 16.32, 27.64; I²=22%, P<0.05), St. George's Respiratory Questionnaire (SGRQ) score (95%CI: −1.47, −1.05; I²=13%, P<0.05), and total effective rate (95%CI: 2.71, 6.78; I²=0%, P<0.05) in patients with pneumoconiosis. In addition, BHC had less adverse reactions reported (95%CI: 0.69, 1.74; I²=0%, P=0.70). Conclusions Combined BHC therapy can significantly improve the lung function and the quality of life in patients with pneumoconiosis, with a good safety profile. However, high-quality RCTs with multicenter, large-sample, double-blind, and standardized protocols still need to be conducted in the future to provide more reliable evidence.