Table 2 Signal strength of reports of omalizumab at the PT level in the FAERS database.

Ear and labyrinth disorders

Ear pain

235

3.68

(3.24–4.19)

3.68

(452.21)

3.64

(3.27)

1.86

(0.2)

Gastrointestinal disorders

Lip swelling*

439

4.05

(3.68–4.45)

4.04

(989.59)

3.99

(3.69)

2

(0.33)

Paraesthesia oral*

161

3.45

(2.95–4.03)

3.45

(276.24)

3.42

(3)

1.77

(0.11)

General disorders and administration site conditions

No adverse event

5316

10.82

(10.52–11.13)

10.56 (44,336.67)

10.19 (9.95)

3.35

(1.68)

Chest discomfort

1459

4.48

(4.25–4.72)

4.45 (3848.43)

4.4

(4.21)

2.14

(0.47)

Sensitivity to weather change*

355

23.88

(21.42–26.62)

23.84 (7121.04)

21.94 (20.03)

4.46

(2.79)

Secretion discharge*

263

7.11

(6.29–8.04)

7.1 (1343.03)

6.94

(6.27)

2.8

(1.13)

Temperature intolerance*

127

3.93

(3.3–4.68)

3.92 (272.73)

3.88

(3.35)

1.96

(0.29)

Concomitant disease aggravated*

110

5.24

(4.34–6.33)

5.24 (369.99)

5.16

(4.4)

2.37

(0.7)

Immune system disorders

Anaphylactic reaction

2768

17.28

(16.62–17.96)

17.05 (39,302.94)

16.07 (15.56)

4.01

(2.34)

Hypersensitivity

1992

3.3

(3.15–3.45)

3.27 (3116.19)

3.25

(3.13)

1.7

(0.03)

Anaphylactic shock

434

5.42

(4.93–5.96)

5.41 (1528.68)

5.32

(4.91)

2.41

(0.75)

Seasonal allergy*

325

7.71

(6.9–8.61)

7.7 (1839.68)

7.5

(6.84)

2.91

(1.24)

Food allergy

192

9.32

(8.07–10.76)

9.31 (1375.05)

9.02

(8)

3.17

(1.51)

Serum sickness

116

12.81

(10.63–15.43)

12.8 (1203.12)

12.25 (10.48)

3.61

(1.95)

Anaphylactoid reaction*

107

7.94

(6.55–9.62)

7.93 (629.35)

7.73

(6.58)

2.95

(1.28)

Perfume sensitivity*

101

78.15

(62.58–97.6)

78.11 (5923.55)

60.41 (50.16)

5.92

(4.25)

Infections and infestations

Nasopharyngitis

1971

3.35

(3.21–3.51)

3.33 (3182.6)

3.3

(3.18)

1.72

(0.06)

Influenza*

1344

3.91

(3.7–4.12)

3.89 (2846.17)

3.85

(3.68)

1.94

(0.28)

Sinusitis

1103

3.28

(3.09–3.48)

3.27 (1715.39)

3.24

(3.08)

1.7

(0.03)

Bronchitis

1094

4.39

(4.13–4.66)

4.37 (2799.34)

4.31

(4.1)

2.11

(0.44)

Lower respiratory tract infection*

616

4.49

(4.14–4.86)

4.48 (1636.87)

4.42

(4.13)

2.14

(0.48)

Respiratory tract infection

341

4.22

(3.79–4.7)

4.21 (822.69)

4.16

(3.81)

2.06

(0.39)

Rhinitis*

153

5.91

(5.03–6.94)

5.9

(609.71)

5.8

(5.07)

2.54

(0.87)

Injury, poisoning and procedural complications

Intercepted product storage error*

181

23.38

(20.08–27.23)

23.36 (3557.75)

21.53 (18.96)

4.43

(2.76)

Intercepted medication error*

162

10.03

(8.57–11.74)

10.02 (1267.67)

9.69

(8.5)

3.28

(1.61)

Scratch*

139

4.63

(3.91–5.47)

4.62 (387.86)

4.56

(3.96)

2.19

(0.52)

Ligament sprain*

132

4.17

(3.51–4.95)

4.17 (312.61)

4.12

(3.56)

2.04

(0.38)

Maternal exposure timing unspecified*

102

9.79

(8.03–11.92)

9.78 (775.21)

9.47

(8.02)

3.24

(1.58)

Investigations

Heart rate increased*

1115

3.43

(3.24–3.64)

3.42 (1888.25)

3.39

(3.23)

1.76

(0.1)

Forced expiratory volume decreased*

792

132.61

(121.74–144.45)

132.08 (68,517.51)

88.17 (82.08)

6.46

(4.8)

Blood pressure systolic increased

699

11.12

(10.31–11.99)

11.08 (6153.54)

10.67 (10.02)

3.42

(1.75)

Body temperature decreased*

496

15.22

(13.9–16.66)

15.18 (6211.62)

14.4 (13.35)

3.85

(2.18)

Blood immunoglobulin E increased*

443

71.89

(64.72–79.87)

71.74 (24,261.78)

56.54 (51.78)

5.82

(4.15)

Respiratory rate increased*

349

12.33

(11.08–13.73)

12.31 (3465.31)

11.81 (10.79)

3.56

(1.9)

Breath sounds abnormal*

215

14.33

(12.49–16.44)

14.31 (2524.77)

13.62 (12.15)

3.77

(2.1)

Pulmonary function test decreased*

166

11.55

(9.89–13.5)

11.54 (1531.33)

11.1

(9.74)

3.47

(1.81)

Eosinophil count increased

129

4.78

(4.01–5.69)

4.77 (378.05)

4.71

(4.07)

2.23

(0.57)

Forced vital capacity decreased*

105

65.11

(52.58–80.63)

65.08 (5307.36)

52.33 (43.76)

5.71

(4.04)

Pregnancy, puerperium and perinatal conditions

Pregnancy

389

5.57

(5.03–6.15)

5.56 (1423.93)

5.46

(5.02)

2.45

(0.78)

Product issues

Needle issue

287

3.49

(3.1–3.92)

3.49

(502.1)

3.45

(3.13)

1.79

(0.12)

Psychiatric disorders

Middle insomnia*

579

9.94

(9.15–10.8)

9.91 (4472.6)

9.59

(8.94)

3.26

(1.6)

Respiratory, thoracic and mediastinal disorders

Asthma

5952

19.24

(18.74–19.76)

18.7 (93,230.94)

17.52 (17.13)

4.13

(2.47)

Cough

3013

3.38

(3.26–3.51)

3.35 (4922.23)

3.32

(3.22)

1.73

(0.06)

Wheezing*

2199

12.63

(12.1–13.19)

12.5 (22,231.25)

11.98 (11.56)

3.58

(1.92)

Productive cough*

1163

8.09

(7.63–8.58)

8.05 (6969.12)

7.84

(7.46)

2.97

(1.3)

Oropharyngeal pain

980

3.25

(3.05–3.46)

3.24 (1497.77)

3.21

(3.04)

1.68

(0.02)

Nasal congestion

913

4.99

(4.67–5.33)

4.97 (2843.22)

4.9

(4.63)

2.29

(0.63)

Rhinorrhoea*

732

3.56

(3.31–3.83)

3.56 (1327.58)

3.52

(3.31)

1.82

(0.15)

Sputum discoloured*

611

21.33

(19.64–23.17)

21.27 (10,918.71)

19.75 (18.43)

4.3

(2.64)

Obstructive airways disorder*

602

17.39

(16.01—18.89)

17.34 (8696.77)

16.33 (15.24)

4.03

(2.36)

Dyspnoea exertional*

532

4.48

(4.12–4.89)

4.48 (1412.64)

4.42

(4.11)

2.14

(0.48)

Asthmatic crisis*

500

47.3

(43–52.03)

47.19 (19,157.24)

40.14 (37.06)

5.33

(3.66)

Respiratory disorder*

489

5.03

(4.59–5.5)

5.02 (1543.23)

4.94

(4.58)

2.3

(0.64)

Throat tightness*

477

5.43

(4.96–5.94)

5.42 (1683.89)

5.33

(4.94)

2.41

(0.75)

Respiratory tract congestion*

386

7.72

(6.97–8.54)

7.7 (2188.48)

7.51

(6.9)

2.91

(1.24)

Bronchospasm

350

7.4

(6.65–8.23)

7.39 (1880.26)

7.21

(6.6)

2.85

(1.18)

Sneezing*

284

3.98

(3.54–4.48)

3.98

(623.4)

3.93

(3.56)

1.98

(0.31)

Sinus congestion*

269

6.09

(5.39–6.87)

6.08 (1116.43)

5.97

(5.39)

2.58

(0.91)

Pulmonary congestion

210

4.94

(4.31–5.67)

4.94

(648)

4.87

(4.34)

2.28

(0.62)

Pharyngeal swelling*

196

7.36

(6.39–8.48)

7.35 (1046.89)

7.18

(6.38)

2.84

(1.18)

Pharyngeal oedema

195

3.42

(2.97–3.94)

3.42

(330)

3.39

(3.01)

1.76

(0.1)

Hypoventilation*

195

18.06

(15.62–20.88)

18.04 (2936.56)

16.94

(15)

4.08

(2.42)

Nasal polyps

192

20.08

(17.34–23.26)

20.06 (3230.5)

18.71 (16.54)

4.23

(2.56)

Rales*

187

9.79

(8.46–11.33)

9.78 (1421.06)

9.46

(8.38)

3.24

(1.58)

Lower respiratory tract congestion*

172

35.68

(30.42–41.84)

35.65 (5098.91)

31.5

(27.57)

4.98

(3.31)

Aphonia*

170

3.79

(3.26–4.42)

3.79 (344.58)

3.75

(3.31)

1.91

(0.24)

Rhinitis allergic*

145

10.3

(8.72–12.16)

10.29 (1170.41)

9.94

(8.65)

3.31

(1.65)

Upper-airway cough syndrome*

139

5.44

(4.6–6.44)

5.44 (493.51)

5.35

(4.65)

2.42

(0.7)

Bronchiectasis*

100

4.91

(4.03–5.98)

4.9

(305.12)

4.83

(4.09)

2.27

(0.61)

Skin and subcutaneous tissue disorders

Urticaria

4885

9.7

(9.42–9.98)

9.49 (35,885.67)

9.19

(8.97)

3.2

(1.53)

Angioedema

906

6.41

(6–6.84)

6.38 (4016.22)

6.25

(5.92)

2.64

(0.98)

Chronic spontaneous urticaria

229

127.61

(108.97–149.45)

127.47 (19,333.82)

86.09 (75.43)

6.43

(4.76)

Skin plaque*

217

7.79

(6.8–8.91)

7.78 (1245.47)

7.59

(6.77)

2.92

(1.26)