Safety of drugs used for the treatment of Crohn’s disease

Aviv Pudipeddi*, Viraj Kariyawasam, Craig Haifer, Brandon Baraty, Sudarshan Paramsothy, Rupert W. L. Leong

*Corresponding author for this work

    Research output: Contribution to journalReview articlepeer-review

    21 Citations (Scopus)


    Introduction: Medications in treating Crohn’s disease (CD) have evolved over the last two decades, particularly with the use of biologic agents. There are, however, concerns about the safety and adverse events associated with these medications. The authors review the safety profile of immunosuppressive medications used in Crohn’s disease in adult patients. Areas covered: The authors performed a literature search until October 2018 to examine safety data on thiopurines, methotrexate, anti-TNFα agents, vedolizumab and ustekinumab. The authors focused on ‘trial’ and ‘real-world’ data for the biologic agents. Safety in pregnancy and the elderly are also presented. Expert opinion: Available data in CD suggest that immunosuppressive medications are relatively safe, although there are concerns about an elevated risk of serious infections, skin cancer and lymphoma particularly with thiopurines and anti-TNFα agents. Data on vedolizumab and ustekinumab suggest these newer biologic agents are well tolerated; however, longer term data in CD are required to identify risks with extended use. Apart from methotrexate, there appear to be no adverse congenital outcomes with exposure of drugs during pregnancy.

    Original languageEnglish
    Pages (from-to)357-367
    Number of pages11
    JournalExpert Opinion on Drug Safety
    Issue number5
    Publication statusPublished - 4 May 2019


    • Adalimumab
    • anti-TNFα
    • Crohn’s disease
    • inflammatory bowel disease
    • infliximab
    • methotrexate
    • safety
    • thiopurine
    • ustekinumab
    • vedolizumab


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