Objective:

To identify medications most frequently reported in connection with inflammatory bowel disease (IBD) by analyzing data from FAERS and JADER.

Approach:

• Data Extraction: Reports of drug-associated IBD adverse events were extracted from FAERS and validated using JADER.
• Disproportionality Analyses: Four methods were used: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS).
• Additional Analyses: Included time-to-onset assessment, Weibull distribution modeling, and subgroup analyses by age, sex, and IBD subtype.

Key Findings:

• TheFAERSdatabaseyielded52,395reportsofdrug-associatedIBD,correspondingto50,426patients.Femalesaccountedforahigherproportionofreportsthanmales,withthemajorityofcasesoccurringinindividualsaged18–64years.Theannualnumberofreportsshowedanoverallupwardtrend.Amongdrugsreportedatleast50times,17metallfouralgorithmicthresholdcriteriaandwereclassifiedaspositivesignals.Anti–tumornecrosisfactor-alpha(anti-TNF-α)inhibitorsrankedhighestbyreportingfrequency,whereasisotretinoindemonstratedthestrongestsignalintensity.ExternalvalidationusingJADERconfirmedconsistentsignalsforcertainanti-TNF-αinhibitors,anti–interleukinbiologicagents,conventionalimmunosuppressants,andantibiotics.Time-to-onsetanalysisrevealedthatthemedianonsetofIBDoccurredwithinoneyearformostdrug-associatedcases.

Interpretation:

The study provides a comprehensive overview of medications associated with IBD, highlighting the need for monitoring drug-related risks.

Limitations:

• Thestudyreliesonspontaneousreportingsystems,whichmayhaveunderreportingorbias.Confirmationinlargeprospectivecohortstudiesisnecessary.

Conclusion:

The findings deliver real-world evidence to support the identification and monitoring of drug-associated IBD.