The real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database

Table 3 Summary of basic demographic and clinical information of reports associated with empagliflozin based on the FAERS database

Characteristics	Case number, n	Case proportion, %
Number of events	20,734
Gender
Male	9744	47.0
Female	8645	41.7
Unknown	2345	11.3
Age (years)
< 18	0	0.0
18 ≤ and < 65	245	1.2
≥ 65	422	2.0
Unknown	20,067	96.8
Weight (kg)
< 80	1496	7.2
80 ≤ and ≤ 100	1316	6.3
> 100	1206	5.8
Unknown	16,716	80.6
Year
2014	154	0.7
2015	666	3.2
2016	1377	6.6
2017	1800	8.7
2018	2596	12.5
2019	3825	18.4
2020	3225	15.6
2021	3665	17.7
2022	2171	10.5
2023Q1	1255	6.1
Serious outcome
Hospitalization–initial or prolonged (HO)	6615	31.9
Life-threatening (LT)	1465	7.1
Death (DE)	573	2.8
Disability (DS)	417	2.0
Required intervention to prevent permanent impairment/damage (RI)	84	0.4
Other serious (important medical event) (OT)	7141	34.4
Unknown	4439	21.4
Reported countries(top 5)
United states	13,043	62.9
United kingdom	1049	5.1
Germany	1037	5.0
Japan	801	3.9
Canada	743	3.6
Reported person
Health professional	12,303	59.3
Non-health professional	8283	39.9
Unknown	148	0.7

ISSN: 2050-6511