SynthesisCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2015
Common harms from amoxicillin: a systematic review and meta-analysis of randomized placebo-controlled trials for any indication.
Synthesis in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 10 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
71 citing papers in PubMed, 10 syntheses or guidelines pooled it, 149 citations in OpenAlex.
- SAGES white paper on antibiotic omission in the management of acute uncomplicated diverticulitis: why, when, who, and most importantly, how.Surgical endoscopy · 2025Guideline
- Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2023Pooled it
- Pharmacokinetics of Clavulanic Acid in the Pediatric Population: A Systematic Literature Review.Clinical pharmacokinetics · 2022Pooled it
- Antibiotic regimens for early-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021Pooled it
- Antibiotic regimens for late-onset neonatal sepsis.The Cochrane database of systematic reviews · 2021Pooled it
- Are systemic antibiotics indicated in children presenting with an odontogenic abscess in the primary dentition? A systematic review of the literature.Clinical oral investigations · 2021Pooled it
- Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019Guideline
- Antibiotics for otitis media with effusion in children.The Cochrane database of systematic reviews · 2016Pooled it
- Interventions to facilitate shared decision making to address antibiotic use for acute respiratory infections in primary care.The Cochrane database of systematic reviews · 2015Pooled it
- Antibiotics for acute otitis media in children.The Cochrane database of systematic reviews · 2015Pooled it
- Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi.Scientific reports · 2022Trial
- High-Dose vs Standard-Dose Amoxicillin Plus Clavulanate for Adults With Acute Sinusitis: A Randomized Clinical Trial.JAMA network open · 2021Trial
- Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi.BMJ open respiratory research · 2019Trial
- Trial
- Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.Antimicrobial agents and chemotherapy · 2017Trial
- Antibiotic use and adherence to Finnish treatment guidelines in pediatric acute otitis media.European journal of pediatrics · 2026Article
- Amikacin toxicity revisited: pentoxifylline offers protection in high-risk treatment scenarios.AMB Express · 2025Article
- Saline nasal irrigation for acute sinusitis (SNIFS II): a randomised controlled pilot trial with nested process evaluation.BJGP open · 2025Article
- From Bacillus Criminalis to the Legalome: Will Neuromicrobiology Impact 21st Century Criminal Justice?Brain sciences · 2025Article
- Novel Macrolide Antibiotic Nafithromycin for Tackling Emerging Resistance in Respiratory Pathogens Encountered in India.Current microbiology · 2025Review
11 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhen prescribing antibiotics for common indications, clinicians need information about both harms and benefits, information that is currently available only from observational studies. We quantified the common harms of the most frequently prescribed antibiotic, amoxicillin, from randomized placebo-controlled trials.
methodsFor this systematic review, we searched MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, without language restriction, for any randomized, participant-blinded, placebo-controlled trials of amoxicillin or amoxicillin-clavulanic acid for any indication, in any setting. Our main outcome was any reported adverse event.
resultsOf 730 studies identified, we included 45 trials: 27 involving amoxicillin, 17 involving amoxicillin-clavulanic acid and 1 involving both. The indications for antibiotic therapy were variable. The risk of bias was low, although only 25 trials provided data suitable for assessment of harms, which suggested under-reporting. Diarrhea was attributed to amoxicillin only in the form of amoxicillin-clavulanic acid (Peto odds ratio [OR] 3.30, 95% confidence interval [CI] 2.23-4.87). The OR for candidiasis (3 trials) was significantly higher (OR 7.77, 95% CI 2.23-27.11). Rashes, nausea, itching, vomiting and abnormal results on liver function tests were not significantly increased. The results were not altered by sensitivity analyses, nor did funnel plots suggest publication bias. The number of courses of antibiotics needed to harm was 10 (95% CI 6-17) for diarrhea with amoxicillin-clavulanic acid and 27 (95% CI 24-42) for candidiasis with amoxicillin (with or without clavulanic acid).
interpretationDiarrhea was caused by use of amoxicillin-clavulanic acid, and candidiasis was caused by both amoxicillin and amoxicillin-clavulanic acid. Harms were poorly reported in most trials, and their true incidence may have been higher than reported. Nevertheless, these rates of common harms associated with amoxicillin therapy may inform decisions by helping clinicians to balance harms against benefits.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.