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Urinary tract infections, urosepsis, and multiple sclerosis disease modifying therapies: a disproportionality

Alexandra Balshi1, Madelyn Esser2, Tamara B Kaplan3

  • 1Harvard Medical School, Boston, MA, USA.

Multiple Sclerosis and Related Disorders
|July 11, 2026
PubMed

Insights

Advanced multiple sclerosis (MS) patients face risks from urinary tract infections (UTIs) and urosepsis. Certain disease-modifying therapies (DMTs), like ocrelizumab, may increase UTI risk, necessitating vigilance in MS care.

Area of Science:

  • Neurology
  • Infectious Diseases
  • Pharmacovigilance

Background:

  • Infection-related complications, such as urinary tract infections (UTIs) and urosepsis, significantly contribute to morbidity and mortality in advanced multiple sclerosis (MS).
  • The specific impact of various disease-modifying therapies (DMTs) on UTI and urosepsis risk in MS patients is not well-understood.

Purpose of the Study:

  • To investigate the association between different DMTs used in MS treatment and the risk of developing UTIs and urosepsis.
  • To identify specific DMTs that may be linked to a higher incidence of these infection-related complications.

Main Methods:

  • Analysis of the FDA Adverse Event Reporting System (FAERS) database.
  • Identification and quantification of reported cases of UTIs and urosepsis linked to various MS DMTs.
  • Statistical assessment to determine safety signals for specific DMTs regarding UTI and urosepsis.

Main Results:

  • A total of 12,997 UTI reports and 651 urosepsis reports were identified in association with MS DMTs.
  • Ocrelizumab showed the most significant safety signal for UTI risk.
  • Natalizumab, alemtuzumab, and interferon beta-1a were also disproportionately associated with high reporting rates of UTIs across different demographic subgroups.

Conclusions:

  • Clinicians managing MS patients should maintain heightened vigilance for UTIs.
  • Proactive bladder management strategies should be integrated into the routine care of individuals with MS, particularly those on specific DMTs.
  • Further research may be warranted to elucidate the mechanisms behind these associations and to refine treatment guidelines.
Keywords:
Disease-modifying therapyFAERSMultiple sclerosisPharmacovigilanceUrinary tract infection

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