3. Results
3.1Characteristic analysis of AE reports
The FAERS databse contained a total of 55,949 AE reports associated with pirfenidone and 35,884 reports associated with nintedanib (Figure 1). These numbers exceeded the corresponding figures reported in the VigiAccess database (37,187 and 23,134). Furthermore, the occurrence of cases was more frequent in males than in females for both drugs in both databases (Pirfenidone: 60.09% vs. 36.73% in the FAERS database; 63.36% vs. 33.45% in the VigiAccess database, Nintedanib: 55.98% vs. 38.66% in the FAERS database; 59.17% vs. 34.94% in the VigiAccess database). In terms of age distribution in the FAERS database, patients over the age of 65 were more likely to report AE, accounting for 16,716 (29.88%) in pirfenidone and 20,330 (56.65%) in nintedanib. Similar results were shown in the VigiAccess database (14,409, 38.75%; 13,245, 57.25%). However, more than half of cases (20,047, 53.91%) lacked age information for pirfenidone. The main reporting continent was Americas for both drugs in both databases. Among the all cases, the most severe outcome was hospitalization (10,869, 19.43% for pirfenidone; 17,433, 48.58% for nintedanib). In addition, AE reports for these drugs showed an increasing trend over the years.