Table 2 Positive signal strength for liver injuries associated with taxanes based on PT levels of FAERS.

Hepatobiliary disorders

Pseudocirrhosis

30

61.77 (42.04, 90.77)

5.74 (5.2)

–

–

–

7

18.81 (8.85, 39.98)

4.18 (3.16)

Hepatic atrophy

41

49.81 (35.94, 69.04)

5.45 (4.99)

–

–

–

–

–

–

Hypertransaminasaemia

99

10.51 (8.56, 12.91)

3.28 (2.99)

–

–

–

24

3.52 (2.35, 5.29)

1.79 (1.21)

Immune-mediated hepatitis

17

6.81 (4.21, 11.02)

2.74 (2.06)

–

–

–

22

13.07 (8.53, 20.03)

3.65 (3.05)

Hepatic cytolysis

60

4.36 (3.37, 5.65)

2.07 (1.7)

–

–

–

–

–

–

Mixed liver injury

15

3.4 (2.04, 5.67)

1.75 (1.04)

–

–

–

–

–

–

Hepatitis acute

41

3.3 (2.42, 4.5)

1.69 (1.25)

–

–

–

4

0.51 (0.19, 1.36)

− 0.97 (− 2.23)

Hepatitis fulminant

15

2.53 (1.52, 4.22)

1.33 (0.61)

5

3.38 (1.4, 8.18)

1.74(0.58)

3

0.86 (0.28, 2.68)

− 0.21 (− 1.63)

Hepatocellular injury

68

2.36 (1.85, 3.01)

1.2 (0.85)

13

1.75 (1.01, 3.05)

0.79 (0.02)

4

0.2 (0.07, 0.52)

− 2.32 (− 3.59)

Hyperbilirubinaemia

41

2.11 (1.55, 2.89)

1.06 (0.61)

7

1.46 (0.69, 3.08)

0.53 (− 0.48)

19

1.52 (0.96, 2.39)

0.59 (− 0.05)

Jaundice cholestatic

11

1.55 (0.86, 2.81)

0.63 (− 0.19)

–

–

–

11

2.6 (1.43, 4.72)

1.37 (0.54)

Cholestasis

56

1.55 (1.19, 2.03)

0.62 (0.23)

5

0.54 (0.23, 1.32)

− 0.86 (− 2.02)

14

0.61 (0.36, 1.03)

− 0.7 (− 1.44)

Hepatotoxicity

63

1.52 (1.18, 1.96)

0.59 (0.22)

3

0.3 (0.09, 0.92)

− 1.73 (− 3.15)

36

1.35 (0.97, 1.88)

0.42 (− 0.06)

Hepatic failure

87

1.47 (1.18, 1.83)

0.53 (0.22)

32

2.19 (1.52, 3.14)

1.06 (0.55)

64

1.82 (1.41, 2.35)

0.82 (0.46)

Hepatic function abnormal

85

1.23 (0.98, 1.53)

0.28 (− 0.03)

20

1.18 (0.76, 1.86)

0.23 (− 0.4)

80

1.89 (1.51, 2.38)

0.86 (0.54)

Hepatic lesion

9

1.09 (0.57, 2.1)

0.12 (− 0.77)

–

–

–

10

1.89 (1.01, 3.52)

0.91 (0.05)

Hepatic pain

8

0.96 (0.48, 1.92)

− 0.06 (− 1.01)

4

1.99 (0.74, 5.33)

0.98 (− 0.29)

3

0.55 (0.18, 1.7)

− 0.86 (− 2.28)

Liver injury

35

0.89 (0.64, 1.25)

− 0.16 (− 0.63)

4

0.46 (0.17, 1.22)

− 1.11 (− 2.39)

10

0.38 (0.2, 0.7)

− 1.38 (− 2.24)

Drug-induced liver injury

44

0.87 (0.64, 1.17)

− 0.2 (− 0.63)

4

0.35 (0.13, 0.93)

− 1.5 (− 2.78)

19

0.54 (0.34, 0.85)

− 0.87 (− 1.51)

Hepatitis

40

0.8 (0.59, 1.1)

− 0.31 (− 0.75)

–

–

–

24

0.8 (0.53, 1.19)

− 0.32 (− 0.89)

Acute hepatic failure

18

0.7 (0.44, 1.12)

− 0.5 (− 1.15)

–

–

–

3

0.17 (0.06, 0.54)

− 2.49 (− 3.91)

Jaundice

39

0.7 (0.51, 0.96)

− 0.5 (− 0.95)

19

1.36 (0.86, 2.15)

0.42 (− 0.23)

47

1.43 (1.07, 1.92)

0.5 (0.08)

Hepatomegaly

13

0.63 (0.37, 1.09)

− 0.65 (− 1.41)

9

1.76 (0.91, 3.4)

0.8 (− 0.11)

8

0.67 (0.33, 1.33)

− 0.58 (− 1.53)

Autoimmune hepatitis

8

0.61 (0.31, 1.23)

− 0.7 (− 1.65)

–

–

–

14

1.69 (1, 2.86)

0.75 (0.01)

Hepatitis cholestatic

7

0.61 (0.29, 1.28)

− 0.71 (− 1.71)

–

–

–

–

–

–

Hepatic cirrhosis

21

0.6 (0.39, 0.92)

− 0.73 (− 1.33)

10

1.19 (0.63, 2.22)

0.24 (− 0.62)

9

0.4 (0.21, 0.77)

− 1.3 (− 2.2)

Hepatitis toxic

3

0.56 (0.18, 1.74)

− 0.83 (− 2.25)

–

–

–

–

–

–

Hepatic necrosis

4

0.5 (0.19, 1.34)

− 0.98 (− 2.25)

4

1.94 (0.72, 5.2)

0.95 (− 0.33)

–

–

–

Hepatic steatosis

17

0.46 (0.29, 0.75)

− 1.09 (− 1.76)

4

0.44 (0.17, 1.19)

− 1.15 (− 2.42)

8

0.36 (0.18, 0.71)

− 1.47 (− 2.42)

Liver disorder

25

0.28 (0.19, 0.42)

− 1.76 (− 2.32)

15

0.72 (0.43, 1.2)

− 0.46 (− 1.18)

50

0.93 (0.7, 1.24)

− 0.1 (− 0.5)

Liver tenderness

–

–

–

4

26.33 (9.75, 71.1)

4.68 (3.4)

–

–

–

Hepatobiliary disease

–

–

–

–

–

–

5

6.67 (2.76, 16.14)

2.72 (1.55)

Ocular icterus

–

–

–

–

–

–

3

0.55 (0.18, 1.72)

− 0.85 (− 2.26)

Investigations

Transaminases increased

81

1.9 (1.52, 2.38)

0.89 (0.57)

6

0.54 (0.24, 1.21)

− 0.87 (− 1.95)

57

2.1 (1.61, 2.75)

1.03 (0.64)

Aspartate aminotransferase increased

123

1.16 (0.97, 1.4)

0.2 (− 0.06)

45

1.75 (1.28, 2.39)

0.73 (0.29)

106

1.84 (1.5, 2.25)

0.81 (0.52)

Gamma-glutamyltransferase increased

51

1.12 (0.84, 1.47)

0.15 (− 0.25)

10

0.84 (0.45, 1.57)

− 0.24 (− 0.11)

27

1.03 (0.7, 1.51)

0.04 (− 0.5)

Alanine aminotransferase increased

136

1.11 (0.93, 1.33)

0.14 (− 0.11)

53

1.81 (1.36, 2.42)

0.77 (0.36)

113

1.66 (1.36, 2.02)

0.66 (0.38)

Alanine aminotransferase abnormal

4

1.05 (0.39, 2.79)

0.06 (− 1.2)

–

–

–

–

–

–

Blood bilirubin increased

37

0.67 (0.48, 0.93)

− 0.56 (− 1.03)

37

2.83 (2.02, 3.98)

1.41 (0.93)

77

2.5 (1.98, 3.16)

1.25 (0.92)

Liver function test abnormal

30

0.48 (0.33, 0.69)

− 1.03 (− 1.54)

8

0.5 (0.25, 1)

− 0.91 (− 1.93)

28

0.76 (0.52, 1.11)

− 0.38 (− 0.91)

Liver function test increased

17

0.45 (0.28, 0.73)

− 1.12 (− 1.79)

3

0.34 (0.11, 1.07)

− 1.52 (− 2.94)

17

0.67 (0.41, 1.08)

− 0.57 (− 1.25)

Hepatic enzyme increased

53

0.4 (0.3, 0.52)

− 1.26 (− 1.65)

13

0.41 (0.24, 0.72)

− 1.21 (− 1.98)

18

0.21 (0.13, 0.33)

− 2.18 (− 2.83)

Blood bilirubin decreased

–

–

–

3

11.86 (3.79, 37.08)

3.55 (2.12)

–

–

–

Bilirubin conjugated increased

–

–

–

5

4.23 (1.75, 10.23)

2.06 (0.9)

–

–

–

Hepatic enzyme abnormal

–

–

–

4

1.76 (0.66, 4.7)

0.8 (− 0.47)

4

0.64 (0.24, 1.7)

0.65 (− 1.92)

Ammonia increased

–

–

–

3

1.13 (0.36, 3.53)

0.18 (− 1.24)

–

–

–

Blood bilirubin abnormal

–

–

–

–

–

–

7

4.6 (2.18, 9.69)

2.18 (1.18)

Aspartate aminotransferase abnormal

–

–

–

–

–

–

3

1.81 (0.58, 5.64)

0.86 (− 0.56)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer metastatic

3

1.71 (0.55, 5.32)

0.77 (− 0.65)

–

–

–

–

–

–

Hepatic neoplasm

–

–

–

–

–

–

5

1.2 (0.5, 2.89)

0.26 (− 0.9)

Blood and lymphatic system disorders

Acquired haemophilia

3

1.66 (0.53, 5.17)

0.73 (− 0.69)

–

–

–

–

–

–