Table 3.

Disproportionality analysis of outcomes associated with anaphylactic reactions.

Drugs (total no. of reports)	Anaphylactic reaction associated AEsa	No. of reports (%)	PRR	ROR	IC025
Omalizumab (32,457)	Anaphylactic reactionb	1,437 (4.4%)	9.61	10.01	3.17
	Anaphylactic shock	193 (0.6%)	1.51	1.51	0.38
	Anaphylactoid reaction	82 (0.3%)	1.05	1.05	− 0.26
	Anaphylactoid shock	2 (< 0.1%)	1.74	1.74	− 1.99
	Circulatory collapse	12 (< 0.1%)	0.30	0.30	− 2.63
	Kounis syndrome	1 (< 0.1%)	1.34	1.35	− 3.53
	Shock	12 (< 0.1%)	0.51	0.51	− 1.88
	Shock symptom	1 (< 0.1%)	0.91	0.91	− 3.89
	Type I hypersensitivityb	34 (0.10%)	6.12	6.12	1.97
Mepolizumab (7283)	Anaphylactic reactionb	84 (1.2%)	2.47	2.49	0.97
	Anaphylactic shock	11 (0.2%)	0.38	0.38	− 2.32
	Anaphylactoid reaction	5 (< 0.1%)	0.29	0.29	− 3.24
	Circulatory collapse	2 (< 0.1%)	0.22	0.22	− 2.63
	Shock	1 (< 0.1%)	0.19	0.19	− 5.75
	Type I hypersensitivity	1 (< 0.1%)	0.80	0.80	− 4.03
Benralizumab (2363)	Anaphylactic reactionb	54 (2.3%)	4.90	4.99	1.83
	Anaphylactic shock	3 (0.1%)	0.32	0.32	− 3.54
	Anaphylactoid reaction	3 (0.1%)	0.53	0.53	− 2.87
	Circulatory collapse	2 (0.1%)	0.68	0.68	− 3.04
	Kounis syndrome	1 (< 0.1%)	18.50	18.51	− 2.36
	Shock	1 (< 0.1%)	0.58	0.58	− 4.37
	Type I hypersensitivity	1 (< 0.1%)	2.45	2.45	− 3.07
Reslizumab (313)	Anaphylactic reaction	4 (1.3%)	2.74	2.76	− 0.54
	Anaphylactoid reaction	1 (0.3%)	1.33	1.33	− 3.54
Dupilumab (20,548)	Anaphylactic reaction	37 (0.2%)	0.39	0.38	− 1.86
	Anaphylactic shock	4 (< 0.1%)	0.05	0.05	− 5.92
	Anaphylactoid reaction	1 (< 0.1%)	0.02	0.02	− 8.85
	Circulatory collapse	4 (< 0.1%)	0.16	0.16	− 4.26
	Shock	2 (< 0.1%)	0.13	0.13	− 5.22

PRR, Proportional reporting ratio; ROR, Reporting odds ratio; IC, information component; IC₀₂₅, under 95% confidence interval of IC.

^aAnaphylactic reaction-related AEs were selected using the “anaphylactic reaction” of the standardized MedDRA Query (SMQ).

^bPositive signals detected by disproportionality analysis.