Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data

Table 2 Top 40 preferred terms associated with ustekinumab in Crohn’s disease, ranked by reporting frequency

PT	Case	ROR (95%CI)	PRR (χ2)
Lower respiratory tract infection	909	7.26 (6.7-7.87)	7.2 (3177.4)
Infusion related reaction	698	2.49 (2.3-2.7)	2.48 (524.16)
Clostridium difficile infection	484	3 (2.71-3.31)	2.99 (524.89)
Abscess	481	2.01 (1.82-2.21)	2 (211.21)
Anal abscess	331	2.26 (2.02-2.54)	2.26 (199.72)
Cellulitis	247	2.97 (2.59-3.41)	2.97 (264.89)
Kidney infection	191	3.96 (3.37-4.65)	3.95 (326.71)
Tooth abscess	151	4.69 (3.9-5.64)	4.68 (325.29)
Abdominal abscess	149	2.22 (1.86-2.64)	2.21 (85.35)
Upper respiratory tract infection	140	2.08 (1.74-2.49)	2.08 (68.16)
Respiratory tract infection	137	4.69 (3.86-5.7)	4.69 (295.49)
Cholelithiasis	131	2.02 (1.68-2.43)	2.02 (58.54)
Postoperative wound infection	120	2.33 (1.92-2.82)	2.32 (77.4)
Anaphylactic reaction	115	2.14 (1.76-2.61)	2.14 (60.55)
Rectal abscess	113	2.35 (1.93-2.87)	2.35 (74.76)
Breast cancer	86	2.27 (1.81-2.86)	2.27 (52.51)
Gastroenteritis	80	2.13 (1.68-2.7)	2.13 (41.49)
Infected fistula	65	3 (2.3-3.93)	3 (71.12)
Tonsillitis	65	2.66 (2.04-3.47)	2.66 (56.28)
Squamous cell carcinoma	64	2.19 (1.68-2.85)	2.19 (35.62)
Subcutaneous abscess	64	2.16 (1.66-2.82)	2.16 (34.5)
Device related infection	55	2.39 (1.79-3.18)	2.39 (37.69)
Transient ischaemic attack	54	2.17 (1.63-2.89)	2.17 (29.37)
Abscess limb	50	2.1 (1.56-2.83)	2.1 (25.03)
Multiple sclerosis	44	2.13 (1.55-2.92)	2.13 (22.71)
Peritonitis	44	2.08 (1.52-2.86)	2.08 (21.46)
Facial paralysis	43	4 (2.85-5.62)	4 (74.74)
Liver function test abnormal	43	3.42 (2.45-4.77)	3.42 (58.69)
Escherichia infection	39	2.37 (1.68-3.32)	2.36 (26.16)
Gastroenteritis norovirus	38	10.98 (7.16-16.85)	10.98 (190.62)
Posterior reversible encephalopathy syndrome	38	10.33 (6.77-15.74)	10.32 (181.77)
Complication associated with device	36	3.11 (2.17-4.47)	3.11 (42.04)
Pyelonephritis	33	2.03 (1.41-2.92)	2.03 (14.96)
Gastric infection	33	2.03 (1.41-2.92)	2.03 (14.96)
Mastitis	32	4.35 (2.92-6.47)	4.35 (62.45)
Abdominal infection	30	2.83 (1.91-4.19)	2.83 (29.37)
Interstitial lung disease	30	2.24 (1.52-3.29)	2.24 (17.65)
Groin abscess	29	3.13 (2.09-4.68)	3.13 (34.08)
Infected cyst	28	3.34 (2.21-5.04)	3.34 (36.77)
Cholecystitis	28	2.38 (1.59-3.55)	2.38 (19)

PT: Preferred term; ROR: Reporting odds ratio; PRR: Proportional reporting ratio.