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

Table 3 Key results of drug-induced liver injury associated with antimycotics: Number of cases with relevant disproportionality analyses

Pharmacological class	Activesubstance	Cases LI	CasesALF	CasesOLI	ROR (95%CI) LI	ROR (95%CI)ALF	ROR (95%CI)OLI
Antibiotics	Amphotericin B	251	14	265	5.33 (4.65-6.10)1	2.86 (1.69-4.84)1	5.20 (4.55-5.94)1
Imidazole derivatives	Miconazole2	16	-	16	0.33 (0.20-0.54)	-	0.30 (0.18-0.50)
	Ketoconazole2	88	6	94	6.68 (5.28-8.44)1	4.22 (1.88-9.45)1	6.64 (5.28-8.34)1
Triazole derivatives	Fluconazole	381	31	412	4.25 (3.81-4.74)1	3.46 (2.42-4.93)1	4.26 (3.83-4.73)1
	Itraconazole	178	4	182	3.73 (3.19-4.37)1	0.84 (0.32-2.25)	3.50 (2.99-4.09)1
	Voriconazole	342	19	361	5.61 (4.99-6.31)1	2.97 (1.89-4.67)1	5.48 (4.89-6.14)1
	Posaconazole	65	5	70	5.39 (4.12-7.04)1	4.00 (1.65-9.66)1	5.39 (4.16-6.99)1
Other antimycotics for systemic use	Flucytosine	6	-	6	3.06 (1.31-7.13)1	-	2.80 (1.20-6.52)1
	Caspofungin	161	7	168	7.03 (5.90-7.37)1	2.79 (1.32-5.87)1	6.78 (5.71-8.05)1
	Micafungin	48	2	50	6.90 (5.02-9.49)1	-	6.64 (4.86-9.09)1
	Anidulafungin	13	1	14	4.97 (2.75-9.00)1	-	4.97 (2.79-8.84)1
Antimycotics used for topical indications (dermatological use) with systemic absorption	Griseofulvin3	3	-	3	2.00 (0.62-6.47)	-	1.83 (0.57-5.92)
	Terbinafine3	395	27	422	5.11 (4.58-5.69)1	3.39 (2.32-4.96)1	5.06 (4.55-5.62)1
Antimycotics for topical use with potential systemic absorption (e.g., gynecological and intestinal use)	Nystatin	12	-	12	2.01 (1.12-3.62)1	-	1.84 (1.02-3.31)1
	Econazole	6	-	6	3.25 (1.39-7.60)1	-	2.97 (1.27-6.94)1
	Ciclopirox	3	-	3	3.39 (1.02-11.30)1	-	3.10 (0.93-10.33)

Only agents with at least three cases for the event of interest are shown (i.e., those for which disproportionality can be calculated).

¹Statistically significant disproportionality (Lower limit 95%CI > 1);

²Frequent topical use;

³Also topical use. ALF: Acute liver failure; LI: Liver injury; OLI: Overall liver injury; ROR: Reporting odds ratio.