Can a patient with a history of autoimmune hepatitis be treated with azithromycin (Azithromycin)?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: April 18, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

Azithromycin can be used with caution in patients with a history of autoimmune hepatitis, but close monitoring of liver function tests is recommended due to the potential risk of hepatotoxicity and autoimmune hepatitis flare. When considering the treatment of a patient with a history of autoimmune hepatitis with azithromycin, it is essential to weigh the benefits and risks, prioritizing the patient's morbidity, mortality, and quality of life. According to the EASL clinical practice guidelines for autoimmune hepatitis 1, the diagnosis and treatment of AIH can be challenging due to its heterogeneity and the limited number of patients that can be included in clinical trials. The guidelines emphasize the importance of expert consensus in managing AIH, given the limited data from large controlled studies and trials. In the context of using azithromycin in patients with a history of autoimmune hepatitis, the primary concern is the potential risk of hepatotoxicity and triggering an autoimmune hepatitis flare. However, azithromycin is considered to have a relatively low risk of hepatotoxicity compared to other antibiotics. For adult patients with stable, well-controlled autoimmune hepatitis, the standard azithromycin dosing of 500 mg on day 1 followed by 250 mg daily for 4 additional days can typically be used, but with close monitoring of liver function tests before and during treatment. Some key points to consider when treating patients with a history of autoimmune hepatitis with azithromycin include:

  • Close monitoring of liver function tests before and during treatment
  • Reducing the dose by 50% or selecting an alternative antibiotic with less hepatic metabolism if the patient has active autoimmune hepatitis or significant liver dysfunction (Child-Pugh class C)
  • Informing patients about potential symptoms of hepatic deterioration that should prompt immediate medical attention, such as increased fatigue, jaundice, dark urine, or right upper quadrant pain. It is crucial to prioritize the patient's safety and adjust the treatment plan accordingly, taking into account the potential risks and benefits of using azithromycin in patients with a history of autoimmune hepatitis, as recommended by the EASL clinical practice guidelines 1.

From the FDA Drug Label

Because azithromycin is principally eliminated via the liver, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. The FDA drug label does not answer the question about treating a patient with a history of autoimmune hepatitis with azithromycin, as it only mentions caution with impaired hepatic function, but does not specifically address autoimmune hepatitis.

From the Research

Azithromycin Treatment in Patients with Autoimmune Hepatitis

  • There is limited research on the use of azithromycin in patients with a history of autoimmune hepatitis.
  • Studies have reported cases of azithromycin-induced liver injury, including hepatocellular and cholestatic patterns of injury 2, 3, 4.
  • However, these studies do not specifically address the use of azithromycin in patients with autoimmune hepatitis.
  • One study found that relapse occurred in 67% of patients with autoimmune hepatitis after discontinuation of immunosuppressive treatment, but this study did not involve azithromycin treatment 5.
  • Another study reported on idiosyncratic drug-induced liver injury due to ciprofloxacin, which is a different antibiotic, but highlights the potential for liver injury with certain medications 6.

Considerations for Treatment

  • The decision to treat a patient with a history of autoimmune hepatitis with azithromycin should be made with caution, considering the potential risk of liver injury.
  • Patients should be closely monitored for signs of liver injury, such as elevated liver enzymes and jaundice, if azithromycin is prescribed.
  • The benefits and risks of azithromycin treatment should be carefully weighed, and alternative treatments should be considered if possible.
  • Further research is needed to determine the safety and efficacy of azithromycin in patients with autoimmune hepatitis.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Clinical and histologic features of azithromycin-induced liver injury.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2015

Research

Azithromycin-induced liver injury.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2010

Research

Azithromycin-induced cholestatic hepatitis.

Oxford medical case reports, 2017

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.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.