TABLE 5.

Demographics, clinical data, severity and outcome of patients according to ATC classes ^a

	Antibacterials (n = 66)	Cardiovascular (n = 22)	Immunosuppressants (n = 17)	NSAID (n = 8)	CNS (n = 14)
Age (years), mean ± SD	64 ± 12	65 ± 13	48 ± 20	42 ± 11	51 ± 9.0
Female sex, n (%)	42 (64%)	12 (55%)	13 (76%)	2 (25%)	7 (50%)
Type of liver injury, n (%)
Hepatocellular	30 (51%)	8 (38%)	12 (75%)	5 (71%)	10 (83%)
Cholestatic	11 (19%)	8 (38%)	0 (0%)	1 (14%)	0 (0%)
Mixed	18 (31%)	5 (24%)	4 (25%)	1 (14%)	2 (17%)
Jaundice	49 (78%)	14 (64%)	2 (13%)	3 (38%)	8 (67%)
Hospitalization	39 (61%)	16 (73%)	6 (38%)	6 (75%)	9 (69%)
Rash	7 (11%)	1 (4.5%)	0 (0%)	0 (0%)	0 (0%)
Eosinophilia	13 (21%)	3 (14%)	1 (6.7%)	0 (0%)	1 (8.3%)
Lymphopenia	19 (30%)	4 (18%)	2 (13%)	2 (25%)	1 (8.3%)
Laboratory parameters at onset ( × ULN), median (IQR)
Total bilirubin	4.5 (1.9–7.0)	3.1 (1.2–5.6)	0.6 (0.5–0.8)	1.3 (0.9–3.4)	5.0 (1.0–15)
ALT	12 (7.9–19)	13 (7.0–30)	11 (9.0–18)	17 (11–32)	25 (14–35)
AST	9.5 (4.8–16)	12 (3.8–26)	10 (5.7–13)	17 (4.7–26)	16 (3.5–21)
ALP	2.3 (1.5–3.5)	3.6 (2.6–6.3)	1.3 (1.0–2.7)	2.2 (1.7–2.8)	1.9 (1.3–2.2)
New Hy's Law	18 (29%)	7 (32%)	1 (6.3%)	3 (38%)	7 (54%)
Severity
Mild	17 (28%)	9 (41%)	11 (85%)	5 (63%)	4 (33%)
Moderate	39 (64%)	12 (55%)	0 (0%)	2 (25%)	6 (50%)
Severe	3 (4.9%)	1 (4.5%)	2 (15%)	0 (0%)	1 (8.3%)
Fatal/liver transplantation	2 (3.3%)	0 (0%)	0 (0%)	1 (13%)	1 (8.3%)

Note: Immunosuppressants included were infliximab, azathioprine, leflunomide, adalimumab, natalizumab, vedolizumab.

Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CNS, central nervous system; IQR, interquartile range; NSAID, non‐steroidal anti‐inflammatory drug; SD, standard deviation; ULN, upper limit of normal.

^a Only cases with a single causative agent.