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Hepatotoxicity and Antimicrobial Resistance to Amoxicillin and Amoxicillin/Clavulanic Acid: Data Analysis from

Ilaria Ammendolia1,2, Carmen Mannucci3, Emanuela Esposito1

  • 1Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, 98122 Messina, Italy.

Molecules (Basel, Switzerland)
|September 27, 2025
PubMed

Insights

Amoxicillin/clavulanic acid combination increases risks of hepatobiliary disorders and drug resistance compared to amoxicillin alone. Pharmacovigilance data highlights this safety concern, crucial for combating antimicrobial resistance.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Antimicrobial Resistance
  • Clinical Pharmacology

Background:

  • Amoxicillin is a widely prescribed antibiotic, often combined with clavulanic acid to combat beta-lactamase producing bacteria.
  • Limited data exists on adverse reactions and antibiotic resistance associated with amoxicillin and its combination therapy.
  • Pharmacovigilance databases offer a valuable tool for tracking overlooked adverse events like antimicrobial resistance.

Purpose of the Study:

  • To define the safety profile of amoxicillin and amoxicillin/clavulanic acid.
  • To assess the risk of adverse events, including hepatobiliary disorders and drug inefficiency.
  • To enhance understanding of antimicrobial resistance patterns associated with these antibiotics.

Main Methods:

  • Analysis of suspected adverse reactions reported in the EudraVigilance pharmacovigilance database from 2020-2024.
  • Focus on amoxicillin monotherapy versus amoxicillin/clavulanic acid combination therapy.
  • Disproportionate analysis to identify significant increases in specific adverse event alerts.

Main Results:

  • "Skin and subcutaneous disorders" were the most frequent alerts for both amoxicillin and amoxicillin/clavulanic acid.
  • The amoxicillin/clavulanic acid combination showed a significant increase in alerts for "Hepatobiliary disorders" and "Drug inefficiency" compared to amoxicillin alone.
  • This study is the first post-marketing surveillance to indicate a higher likelihood of antimicrobial resistance with the amoxicillin/clavulanic acid combination.

Conclusions:

  • The amoxicillin/clavulanic acid combination is associated with a higher risk of hepatotoxicity and antimicrobial resistance than amoxicillin monotherapy.
  • Pharmacovigilance data is crucial for identifying and monitoring adverse drug reactions and resistance trends.
  • Findings support the ongoing battle against antimicrobial resistance by informing clinical practice and drug safety monitoring.
Keywords:
adverse reactionsamoxicillinamoxicillin/clavulanic acidantibiotic resistanceantimicrobial resistancehepatotoxicityliver toxicitypharmacovigilance

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