ArticleMolecules (Basel, Switzerland)2025
Hepatotoxicity and Antimicrobial Resistance to Amoxicillin and Amoxicillin/Clavulanic Acid: Data Analysis from EudraVigilance.
Article in Molecules (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Comparative Adverse Event Reporting Patterns of Amoxicillin and Amoxicillin/Clavulanic Acid in FAERS: A 2022-2025 Disproportionality Analysis.Health science reports · 2026Article
- Comparative Outcomes of Amoxicillin and Amoxicillin-Clavulanate in the Treatment of Acute Rhinosinusitis in Adults with Comorbidities: A Retrospective Study.Antibiotics (Basel, Switzerland) · 2026Article
- Feathered innovation: transforming recycled keratin into bioactive micro/nanoparticles for bioactive keratin-based delivery platform.RSC advances · 2026Article
- Adverse Respiratory Reactions to Tyrosine Kinase Inhibitors: A Disproportionality Analysis of Spontaneous Reports from European Countries.Life (Basel, Switzerland) · 2026Article
- Safety of high-dose dual therapy forFrontiers in pharmacology · 2026Article
- Will the introduction of β-lactamase inhibitors alter the adverse event profile of parent penicillins antibiotics? a pharmacovigilance study based on amoxicillin-clavulanate and ampicillin-sulbactam.Frontiers in pharmacology · 2026Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Amoxicillin is widely prescribed, either as a monotherapy or in combination with clavulanic acid, with its therapeutic indications including a broad range of infections. Its combination with clavulanic acid maintains its known activity against strains producing β-lactamase. There are limited studies on adverse reactions and antibiotic resistance, with researchers relying primarily on databanks that report spontaneous events caused by amoxicillin or the combination of amoxicillin/clavulanic acid. Antimicrobial resistance is an overlooked adverse event, and pharmacovigilance databases could serve as a tool in tracking resistance. On this basis, a study to define the safety profile of amoxicillin and amoxicillin/clavulanic acid and to increase the knowledge necessary to support the battle against antimicrobial resistance was undertaken through the analysis of pharmacovigilance databases. Suspected adverse reactions to amoxicillin and to the combination of amoxicillin/clavulanic acid in the data system EudraVigilance (2020-2024) were analyzed. The most frequent alerts concerned "Skin and subcutaneous disorders" for both drugs. Disproportionate analysis of cases concerning "Hepatobiliary disorders" or "Drug inefficiency" indicates a significant increase in these alerts with the amoxicillin/clavulanic acid combination compared to amoxicillin. The amoxicillin/clavulanic acid combination has previously been associated with a higher risk of hepatotoxicity and antibiotic resistance to amoxicillin/clavulanic acid; however, this is the first time that a post-marketing surveillance study has shown that antimicrobial resistance is more likely to occur with the combination in comparison to amoxicillin alone.
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