Table 4 Signal strength of ADEs at the system organ class (SOC) level in FAERS database

General disorders and administration site conditions

10,018,065

197

2.36(1.99,2.80)

1.91(1.70,2.14)

103.15

0.93(0.69)

1.91(1.61)

Infections and infestations

10,021,881

108

4.04(3.28,4.98)

3.49(2.94,4.13)

202.00

1.80(1.47)

3.49(2.83)

Injury, poisoning and procedural complications

10,022,117

35

0.55(0.39,0.77)

0.57(0.41,0.79)

12.48

-0.81(-1.29)

0.57(0.41)

Renal and urinary disorders

10,038,359

35

3.23(2.30,4.54)

3.10(2.25,4.27)

50.69

1.63(1.05)

3.10(2.20)

Nervous system disorders

10,029,205

31

0.59(0.41,0.85)

0.62(0.44,0.87)

8.13

-0.70(-1.21)

0.62(0.43)

Investigations

10,022,891

26

0.70(0.47,1.04)

0.71(0.49,1.04)

3.17

-0.49(-1.04)

0.71(0.48)

Hepatobiliary disorders

10,019,805

25

4.76(3.19,7.11)

4.60(3.14,6.76)

71.18

2.20(1.44)

4.60(3.08)

Respiratory, thoracic and mediastinal disorders

10,038,738

21

0.74(0.48,1.15)

0.75(0.50,1.15)

1.77

-0.41(-1.02)

0.75(0.49)

Blood and lymphatic system disorders

10,005,329

20

2.04(1.31,3.19)

2.00(1.30,3.08)

10.24

1.00(0.29)

2.00(1.28)

Skin and subcutaneous tissue disorders

10,040,785

18

0.55(0.35,0.88)

0.57(0.36,0.89)

6.36

-0.82(-1.46)

0.57(0.35)

Gastrointestinal disorders

10,017,947

15

0.28(0.17,0.47)

0.30(0.18,0.49)

27.14

-1.75(-2.42)

0.30(0.18)

Metabolism and nutrition disorders

10,027,433

14

1.09(0.64,1.85)

1.09(0.65,1.83)

0.11

0.12(-0.64)

1.09(0.64)

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

10,029,104

9

0.57(0.30,1.10)

0.58(0.30,1.10)

2.87

-0.79(-1.65)

0.58(0.30)

Cardiac disorders

10,007,541

9

0.57(0.29,1.10)

0.58(0.30,1.10)

2.89

-0.80(-1.66)

0.58(0.30)

Immune system disorders

10,021,428

7

1.08(0.51,2.27)

1.08(0.52,2.25)

0.04

0.11(-0.94)

1.08(0.51)

Musculoskeletal and connective tissue disorders

10,028,395

5

0.16(0.06,0.38)

0.16(0.07,0.39)

22.65

-2.62(-3.59)

0.16(0.07)

Surgical and medical procedures

10,042,613

4

0.50(0.19,1.34)

0.50(0.19,1.34)

1.99

-0.99(-2.14)

0.50(0.19)

Psychiatric disorders

10,037,175

4

0.11(0.04,0.30)

0.12(0.05,0.32)

27.50

-3.06(-4.08)

0.12(0.04)

Vascular disorders

10,047,065

4

0.31(0.12,0.83)

0.32(0.12,0.84)

6.04

-1.66(-2.75)

0.32(0.12)

Product issues

10,077,536

1

0.10(0.01,0.73)

0.10(0.01,0.74)

7.78

-3.25(-4.44)

0.10(0.01)

Ear and labyrinth disorders

10,013,993

1

0.39(0.05,2.76)

0.39(0.05,2.75)

0.97

-1.36(-2.88)

0.39(0.05)

Congenital, familial and genetic disorders

10,010,331

1

0.56(0.08,3.97)

0.56(0.08,3.96)

0.35

-0.84(-2.53)

0.56(0.08)

Social circumstances

10,041,244

1

0.36(0.05,2.58)

0.36(0.05,2.58)

1.12

-1.46(-2.95)

0.36(0.05)

Eye disorders

10,015,919

1

0.08(0.01,0.59)

0.08(0.01,0.60)

10.07

-3.56(-4.72)

0.08(0.01)