SynthesisEuropean journal of clinical pharmacology2020
Safety of azithromycin in pediatrics: a systematic review and meta-analysis.
Synthesis in European journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis 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.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Secondary Effects from Mass Azithromycin Administration: A Systematic Review and Meta-analysis.The American journal of tropical medicine and hygiene · 2022Pooled it
- Current practices in antibiotic prophylaxis for patients on complement inhibitors: a multicenter survey across ERN ERKnet centers.Clinical kidney journal · 2026Article
- Gastrointestinal safety of oral erythromycin, clarithromycin, and azithromycin in pediatric patients: a FAERS pharmacovigilance study.Pediatric research · 2026Article
- Drug-induced adverse events in modern pharmacotherapy: mechanisms, clinical manifestations, and implications for risk assessment and management.Frontiers in pharmacology · 2026Review
- Article
- Pediatric Pharmacy Association 2025 KIDs List of Key Potentially Inappropriate Drugs in Pediatrics.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Comparative analysis of the clinical characteristics of severe Mycoplasma pneumoniae pneumonia and severe bacterial pneumonia in children.BMC pediatrics · 2025Article
- Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.Journal of pharmaceutical policy and practice · 2025Article
- Preclinical pharmacokinetic studies and prediction of human PK profiles for Deg-AZM, a clinical-stage new transgelin agonist.Frontiers in pharmacology · 2024Article
- Article
- Pregnancy in Cystic Fibrosis-Past, Present, and Future.Journal of clinical medicine · 2023Review
- Article
- Article
- Mass drug administration of antibacterials: weighing the evidence regarding benefits and risks.Infectious diseases of poverty · 2022Review
- Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis.Translational pediatrics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 3 countries.
Funding
Abstract
purposeTo evaluate the toxicity of azithromycin in neonates, infants, and children.
methodsA systematic review was performed for relevant studies using Medline (Ovid), PubMed, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, and International Pharmaceutical Abstracts. We calculated the pooled incidence of adverse drug reactions (ADRs) associated with azithromycin based on prospective studies (RCTs and prospective cohort studies) and analyzed the risk difference (RD) of ADRs between azithromycin and placebo or other antibiotics using meta-analysis of RCTs.
resultsWe included 133 studies with 4243 ADRs reported in 197,675 neonates, infants, and children who received azithromycin. The safety of azithromycin as MDA in pediatrics was poorly monitored. The main ADRs were diarrhea and vomiting. In prospective non-MDA studies, the most common toxicity was gastrointestinal ADRs (938/1967; 47.7%). The most serious toxicities were cardiac (prolonged QT or irregular heart beat) and idiopathic hypertrophic pyloric stenosis (IHPS). Compared with placebo, azithromycin did not show increased risk ADRs based on RCTs (risk difference - 0.17 to 0.07). The incidence of QT prolonged was higher in the medium-dosage group (10-30 mg/kg/day) than that of low-dosage group (≤ 10 mg/kg/day) (82.0% vs 1.2%).
conclusionThe safety of azithromycin as MDA needs further evaluation. The most common ADRs are diarrhea and vomiting. The risk of the most serious uncommon ADRs (cardiac-prolonged QT and IHPS) is unknown.
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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.