Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database

Table 2 Top-10 drugs ranked in FAERS according to their reporting frequency for overall liver injury

ATC code	Active substance	Cases LI	Cases ALF	Cases OLI	ROR (95%CI) LI	ROR (95%CI) ALF	ROR (95%CI) OLI
N02BE01	Paracetamol	2780	645	3425	3.69 (3.54-3.84)1	9.58 (8.82-10.41)1	4.31 (4.16-4.48)1
C10AA05	Atorvastatin	1763	131	1894	3.46 (3.29-3.64)1	2.62 (2.20-3.12)1	3.43 (3.27-3.60)1
C10AA01	Simvastatin	1516	80	1596	2.62 (2.49-2.77)1	1.44 (1.15-1.80)1	2.54 (2.41-2.67)1
N06AX21	Duloxetine	1456	59	1515	3.34 (3.15-3.53)1	1.42 (1.10-1.83)1	3.32 (3.14-3.50)1
L03AB07	Interferon beta-1	1377	46	1423	0.73 (0.70-0.78)	0.27 (0.20-0.36)	0.69 (0.66-0.73)
J05AF05	Lamivudine	1162	130	1292	4.68 (4.40-4.98)1	5.22 (4.38-6.22)1	4.86 (4.57-5.16)1
L01BA01	Methotrexate	1200	86	1286	2.89 (2.72-3.07)1	2.15 (1.74-2.66)1	2.85 (2.69-3.02)1
J01CR02	Amoxicillin/clavulanic acid	1164	94	1258	5.86 (5.49-11.36)1	4.50 (3.67-5.53)1	5.89 (5.54-6.27)1
C02KX01	Bosentan	1177	49	1226	9.53 (8.91-10.19)1	3.35 (3.53-4.45)1	9.20 (8.61-9.83)1
L01XE05	Sorafenib	920	271	1191	4.98 (4.64-5.35)1	15.39 (13.58-17.44)1	6.22 (5.83-6.63)1

¹Statistically significant disproportionality (Lower limit 95%CI > 1). ATC: Anatomical therapeutic chemical classification; ALF: Acute liver failure; LI: Liver injury; OLI: Overall liver injury; ROR: Reporting odds ratio.