Abstract: Objective To investigate the clinical characteristics of and risk factors for pulmonary hemorrhage induced by nintedanib soft capsules in the treatment of progressive pulmonary fibrosis so as to provide a reference for clinical safe medication. Methods A case of a 78-year-old patient with progressive pulmonary fibrosis who developed pulmonary hemorrhage after two doses of nintedanib soft capsules was analyzed. Based on literature review, the possible mechanism and risk factors were explored, and ways of prevention and treatment were recommended. Results Nintedanib soft capsules were immediately discontinued upon the clinician’s instruction. Following hemostatic and supportive treatments, the patient’s hemoptysis gradually subsided. Based on the correlation analysis, the causal relationship between nintedanib soft capsules and pulmonary hemorrhage was assessed as “probable”. Conclusion Before prescribing nintedanib soft capsules, clinicians should assess the patient’s local pulmonary vascular status and general condition while staying alert to the hemorrhagic risk associated with nintedanib soft capsules. Dose reduction or delayed administration should be considered when necessary. During treatment, adverse drug reactions should be monitored to prevent pulmonary hemorrhage.

Key words: Nintedanib Soft Capsules, Progressive Pulmonary Fibrosis, Pulmonary Hemorrhage, Adverse Drug Reaction