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

doi:10.3748/wjg.120684

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World Journal of Gastroenterology

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1007-9327

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Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.

World J Gastroenterol. Aug 7, 2026; 32(29): 120684
Published online Aug 7, 2026. doi: 10.3748/wjg.120684

Table 3 Top 40 preferred terms associated with ustekinumab in Crohn’s disease, ranked by signal strength

PT	Case	ROR (95%Cl)	PRR (χ²)
Cavernous sinus thrombosis	7	95.07 (11.7-772.77)	95.07 (81.44)
Rubella	3	40.74 (4.24-391.71)	40.74 (29.08)
Mastocytosis	3	40.74 (4.24-391.71)	40.74 (29.08)
Vagus nerve disorder	3	40.74 (4.24-391.71)	40.74 (29.08)
Application site vesicles	6	27.16 (6.79-108.62)	27.16 (50.4)
Pneumocephalus	4	27.16 (4.97-148.3)	27.16 (33.6)
Enzyme abnormality	4	27.16 (4.97-148.3)	27.16 (33.6)
Eating disorder symptom	9	24.45 (8.19-72.95)	24.45 (72.28)
External ear cellulitis	10	22.64 (8.23-62.29)	22.63 (77.55)
Neuroendocrine carcinoma metastatic	5	22.64 (5.41-94.72)	22.63 (38.77)
Ophthalmic vein thrombosis	5	22.64 (5.41-94.72)	22.63 (38.77)
Dermatitis exfoliative	9	20.37 (7.25-57.24)	20.37 (66.31)
Neonatal seizure	3	20.37 (3.4-121.92)	20.37 (22.1)
Autoscopy	3	20.37 (3.4-121.92)	20.37 (22.1)
Hyperprolactinaemia	3	20.37 (3.4-121.92)	20.37 (22.1)
Chorioretinopathy	4	18.11 (4.05-80.91)	18.11 (27.71)
Pulseless electrical activity	6	16.3 (4.97-53.4)	16.3 (39.16)
Polymyositis	4	13.58 (3.4-54.31)	13.58 (23.31)
Klebsiella sepsis	4	13.58 (3.4-54.31)	13.58 (23.31)
Periumbilical abscess	4	13.58 (3.4-54.31)	13.58 (23.31)
Vascular access site infection	4	13.58 (3.4-54.31)	13.58 (23.31)
Cryptorchism	3	13.58 (2.74-67.29)	13.58 (17.48)
Fallot’s tetralogy	3	13.58 (2.74-67.29)	13.58 (17.48)
Eczema herpeticum	3	13.58 (2.74-67.29)	13.58 (17.48)
Trigeminal nerve disorder	3	13.58 (2.74-67.29)	13.58 (17.48)
Arteriovenous malformation	3	13.58 (2.74-67.29)	13.58 (17.48)
Gastroenteritis norovirus	38	10.98 (7.16-16.85)	10.98 (190.62)
Muscle abscess	7	10.56 (3.93-28.37)	10.56 (34.09)
Posterior reversible encephalopathy syndrome	38	10.33 (6.77-15.74)	10.32 (181.77)
Language disorder	6	10.19 (3.53-29.36)	10.19 (28.4)
Mumps	3	10.19 (2.28-45.51)	10.19 (14.2)
Human chorionic gonadotropin increased	3	10.19 (2.28-45.51)	10.19 (14.2)
Blood zinc decreased	5	9.7 (3.08-30.57)	9.7 (22.76)
Pharyngotonsillitis	7	9.51 (3.62-24.98)	9.51 (31.34)
Haemophilus infection	4	9.05 (2.55-32.09)	9.05 (17.19)
Ventricular septal defect	5	8.49 (2.78-25.95)	8.49 (20.33)
Chlamydial infection	16	8.36 (4.48-15.58)	8.36 (64.16)
Gastritis bacterial	8	8.36 (3.46-20.17)	8.36 (32.08)
Staring	3	8.15 (1.95-34.1)	8.15 (11.76)
Ewing’s sarcoma	3	8.15 (1.95-34.1)	8.15 (11.76)

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

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Citation: Yao QH, Yang WY. Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data. World J Gastroenterol 2026; 32(29): 120684
URL: https://www.wjgnet.com/1007-9327/full/v32/i29/120684.htm
DOI: https://dx.doi.org/10.3748/wjg.120684

Yao QH, Yang WY. Extending the evidence on ustekinumab safety in Crohn’s disease: A pharmacovigilance disproportionality analysis of FAERS data. World J Gastroenterol 2026; 32(29): 120684 [DOI: 10.3748/wjg.120684]

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