What is the risk of infection associated with azathioprine (immunosuppressant) therapy?

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Last updated: October 15, 2025View editorial policy

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Infection Risk Associated with Azathioprine Therapy

Azathioprine monotherapy does not appear to give rise to a marked increase in susceptibility to infections, but combination with other immunosuppressants significantly increases infection risk. 1

General Infection Risk

  • Azathioprine is classified as causing moderate-severe immunosuppression at doses >3 mg/kg/day, which affects infection susceptibility 1
  • The risk of infection with azathioprine varies depending on:
    • Dosage (higher doses increase risk) 1
    • Combination with other immunosuppressants (particularly corticosteroids) 1
    • Patient factors (age, comorbidities, disease activity) 1
  • Bone marrow suppression, particularly neutropenia, is a dose-dependent side effect occurring in 5-30% of patients that increases infection risk 1
  • Mild lymphopenia is common with thiopurine therapy and may contribute to infection susceptibility 1

Specific Infection Risks

Viral Infections

  • Varicella zoster virus (VZV) infections occur more commonly in patients receiving azathioprine 1
  • Herpesvirus family infections (including cytomegalovirus) are the most frequent opportunistic infections in patients on azathioprine 2
  • Azathioprine selectively induces NK cell depletion and IFN-γ deficiency, predisposing to herpesvirus reactivation 3
  • Fatal cases of Epstein-Barr virus infection have been reported in patients on azathioprine 4

Bacterial and Other Infections

  • Patients receiving immunosuppressants like azathioprine are at increased risk for bacterial, viral, fungal, protozoal, and opportunistic infections, including reactivation of latent infections 5
  • Reactivation of latent tuberculosis has been reported, though routine TB screening is not required before starting azathioprine monotherapy 6
  • Progressive multifocal leukoencephalopathy (PML) from JC virus has been reported in patients on azathioprine 5

Risk Factors for Infection

  • Combination therapy with corticosteroids significantly increases infection risk compared to azathioprine monotherapy 1
  • Elderly patients are at particularly high risk, with infection being a significant cause of mortality in elderly patients with bullous pemphigoid treated with azathioprine and prednisolone 1
  • Patients with hepatic or renal impairment require more careful monitoring due to increased risk 1
  • TPMT or NUDT15 deficiency increases risk of severe myelosuppression, which can lead to secondary infections 5

Monitoring and Prevention

  • Weekly monitoring of full blood count (FBC) for the first 4 weeks of therapy, then monthly or every 2 months for the duration of treatment 1
  • More frequent monitoring is required for patients with hepatic or renal impairment, the elderly, and those on higher doses 1
  • Patients should be instructed to report immediately any evidence of infection, unexpected bruising or bleeding 1
  • Patients who have not previously had chickenpox should be identified before starting azathioprine and advised to seek immediate attention if exposed to VZV 1
  • Live vaccines are contraindicated in patients receiving azathioprine 1
  • Killed vaccines may have diminished efficacy in patients on azathioprine 1

Management of Infections

  • Consider temporary withdrawal of azathioprine if VZV infection occurs 1
  • Prompt use of appropriate antivirals for herpesvirus infections 1, 2
  • Consider reducing immunosuppression in patients who develop PML 5
  • For serious infections, azathioprine should be discontinued and appropriate antimicrobial therapy initiated 5, 2

Common Pitfalls and Caveats

  • Mild lymphopenia is common and not necessarily an indication to reduce dose unless levels fall below 0.5 × 10^9 L^-1 1
  • Infection can occur even without neutropenia, so normal blood counts do not rule out infection risk 1
  • TPMT activity measurement should not be performed just after bone marrow depression as it may be falsely elevated 7
  • Hepatotoxicity may be confused with viral hepatitis (e.g., cytomegalovirus) in patients on azathioprine 8
  • The risk of TB in patients on azathioprine depends on the local disease burden of TB 6

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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