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

Table 1 Basic characteristics of Crohn’s disease patients with adverse events associated with ustekinumab from the United States Food and Drug Administration Adverse Event Reporting System database, n (%)

Characteristics	Total
Number of events	21441 (100)
Gender
Female	12173 (56.8)
Male	7460 (34.8)
Not specified	1808 (8.4)
Age (year)
< 18	550 (2.6)
18-64.9	10959 (51.1)
65-85	1970 (9.2)
> 85	69 (0.3)
Missing	7893 (36.8)
Reporter
Consumer	8912 (41.6)
Health professional	5656 (26.4)
Pharmacist	1780 (8.3)
Physician	3289 (15.3)
Missing	1804 (8.4)
Reported countries (top 3)
United States	11897 (55.5)
Canada	4551 (21.2)
United Kingdom	1721 (8.0)
Other	3272 (15.26)
Outcome
Death	303 (1.4)
Hospitalization	4770 (22.2)
Life-threatening	249 (1.2)
Other	16119 (75.2)
Reporting year
2016	61 (0.3)
2017	962 (4.5)
2018	2151 (10.0)
2019	2589 (12.1)
2020	5164 (24.1)
2021	2412 (11.2)
2022	2505 (11.7)
2023	2351 (11.0)
2024	1712 (8.0)
2025	1534 (7.2)

Full Size Table

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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