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Infection and infestation-related adverse events of ocrelizumab: A disproportionality analysis using FDA adverse

Nesrin Caglayan Duman1

  • 1Department of Medical Pharmacology, Ordu University Faculty of Medicine, Ordu, Turkiye.

Northern Clinics of Istanbul
|January 23, 2026
PubMed
Abstract

Insights

Ocrelizumab use is associated with an increased risk of various infections and infestations, including COVID-19 and central nervous system infections. Careful monitoring is recommended for patients receiving ocrelizumab treatment.

Area of Science:

  • Pharmacovigilance and drug safety research.
  • Immunology and infectious diseases.

Background:

  • Ocrelizumab is a targeted therapy used for autoimmune conditions.
  • Understanding its potential adverse events, particularly infections and infestations, is crucial for patient safety.

Purpose of the Study:

  • To identify and characterize infection and infestation adverse events associated with ocrelizumab using real-world data.
  • To assess the signal strength of these adverse events using disproportionality analysis.

Main Methods:

  • Utilized the FAERS database (Q4 2003–Q3 2024) for adverse event reports where ocrelizumab was the primary suspect.
  • Employed disproportionality analysis with Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms via OpenVigil 2.1.
  • Classified signal intensity as low, medium, or strong based on ROR and PRR values.

Main Results:

  • Identified 161 positive signals for infection and infestation adverse events linked to ocrelizumab.
  • COVID-19 was the most frequently reported event (n=2287).
  • Top adverse events by ROR and PRR included enteroviral encephalitis/meningitis, fallopian tube abscess, nasal herpes, neuroborreliosis, and babesiosis.

Conclusions:

  • Ocrelizumab treatment may elevate the risk of diverse infections and infestations.
  • Specific risks include enterovirus-related CNS infections, tick-borne diseases, COVID-19 complications, genital tract infections, and herpes infections.
  • Close clinical monitoring is essential for patients on ocrelizumab to manage these potential risks.
Keywords:
Adverse eventadverse event reporting systemsinfectioninfestationocrelizumab. https://orcid.org/0000-0002-3215-590X

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