ArticlePharmaceuticals (Basel, Switzerland)2021
Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database.
Article in Pharmaceuticals (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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
5 citing papers in PubMed, 15 citations in OpenAlex.
- Identification of novel signal of DRESS associated with antibiotics: a disproportionality analysis of the FDA adverse event reporting system (FAERS) database.European journal of clinical pharmacology · 2026Article
- Impact of pulmonary infection and antibiotic use on recurrent myocardial infarction in patients with myocardial infarction.Scientific reports · 2025Article
- New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?Pharmacy (Basel, Switzerland) · 2024Review
- Medication-induced osteonecrosis of the jaw: a review of cases from the Food and Drug Administration Adverse Event Reporting System (FAERS).BMC pharmacology & toxicology · 2023Review
- Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.Therapeutics and clinical risk management · 2021Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
This case-non-case study aims to detect signals not currently listed on cephalosporin drug labels. From 2009 to 2018, adverse event (AE) reports concerning antibacterial drugs (anatomical therapeutic chemical (ATC) code J01) in the Korea Adverse Events Reporting System (KAERS) database were examined. For signal detection, three indices of disproportionality, proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were calculated. The list of signals was compared with ADRs on the drug labels from the United States, United Kingdom, Japan, and South Korea. A total of 163,800 cephalosporin-AE combinations and 72,265 all other J01-AE combinations were analyzed. This study detected 472 signals and 114 new signals that are not included on the drug labels. Cefatrizine-corneal edema (PRR, 440.64; ROR, 481.67; IC, 3.84) and cefatrizine-corneal ulceration (PRR, 346.22; ROR, 399.70; IC, 4.40) had the highest PRR, ROR, and IC among all signals. Additionally, six serious AEs that were not listed on drug labels such as cefaclor-induced stupor (ten cases) and cefaclor-induced respiratory depression (four cases) were found. Detecting signals using a national pharmacovigilance database is useful for identifying unknown ADRs. This study identified signals of cephalosporins that warrant further investigation.
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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.