Table 2.
Signal strength of reports of omalizumab at the PT level in the FAERS database.
| Soc name | PTs | Case Numbers |
ROR (95%Cl) |
PRR χ2 |
EBGM (EBGM05) |
IC(IC025) |
|---|---|---|---|---|---|---|
| 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) |
*, ADEs that are not mentioned in the drug label. PT, Preferred Terms.