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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
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Analysis of Onset Timing and Risk Factors for Mesalazine-related Adverse Events Using the JADER Database.

Kuninori Iwayama1, Takayuki Manabe2, Yuya Arai1

  • 1Department of Pharmacotherapy and Therapeutics, Faculty of Pharmaceutical Sciences, Hokkaido University of Science, Sapporo, Japan.

In Vivo (Athens, Greece)
|January 2, 2026
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Summary

Most mesalazine adverse events (AEs) occur early in treatment for inflammatory bowel disease (IBD), but some appear later. Male sex and certain co-administered drugs are linked to mesalazine intolerance, aiding AE monitoring.

Keywords:
JADER databaseMesalazinedrug intoleranceinflammatory bowel disease

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Area of Science:

  • Pharmacovigilance
  • Gastroenterology
  • Drug Safety

Background:

  • Mesalazine is a primary treatment for inflammatory bowel disease (IBD).
  • Serious adverse events (AEs) and drug intolerance can occur with mesalazine, but onset timing and risk factors are not well understood.
  • Effective AE monitoring is crucial for pharmacists managing IBD patients.

Purpose of the Study:

  • To analyze the onset timing of mesalazine-related AEs.
  • To identify risk factors for mesalazine-induced drug intolerance.
  • To provide pharmacists with actionable information for AE monitoring.

Main Methods:

  • Utilized the Japanese Adverse Drug Event Report (JADER) database.
  • Calculated reporting odds ratios (RORs) to detect safety signals for mesalazine-associated AEs.
  • Performed time-to-onset analyses and multivariate logistic regression to evaluate risk factors for drug intolerance.

Main Results:

  • Safety signals were detected for 15 out of 25 prespecified AEs associated with mesalazine.
  • Nine AEs were classified as early-onset, and one as late-onset.
  • Male sex and concomitant use of budesonide, golimumab, vedolizumab, and upadacitinib were significant risk factors for mesalazine intolerance.

Conclusions:

  • The majority of mesalazine-associated AEs manifest early in treatment, with some occurring later.
  • Identified risk factors, including male sex and specific concomitant medications, can inform AE monitoring strategies.
  • Findings offer insights for optimizing therapeutic strategies and improving the quality of life for IBD patients.