Evidence map›Paper›PMID 41546760›Full record

ArticleEuropean journal of clinical pharmacology2026

Identification of novel signal of DRESS associated with antibiotics: a disproportionality analysis of the FDA adverse event reporting system (FAERS) database.

Khushi Goyal, Ruchika Sharma, Ashok Kumar Datusalia, Gopal L Khatik, Anoop Kumar

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Article in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

Authors and funding

5 authors.

Khushi GoyalDepartment of Pharmaceutical Biotechnology, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India.
Ruchika SharmaCentre for Precision Medicine and Pharmacy, Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, India.
Ashok Kumar DatusaliaDepartment of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, India.
Gopal L KhatikDepartment of Medicinal Chemistry, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, India.
Anoop KumarDepartment of Pharmacology, Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), Delhi Pharmaceutical Sciences and Research University (DPSRU), New Delhi, 110017, India. abitmesra@gmail.com.

Funding

Anusandhan National Research Foundation SRG/2022/000011
6 · The paper itself

Abstract

purposeAntibiotics are widely used in the management of bacterial infections However; most antibiotics are not known for DRESS. Our objective is to find out the association of DRESS with available antibiotics using disproportionality analysis.

methodsRetrospective pharmacovigilance disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database from a period of 2004 Q1- 2022 Q3 was conducted using OpenVigil 2.1 tool. Disproportionality measures like Proportional reporting Ratio with associated Chi- square values (PRR ≥ 2 with associated χ2 ≥ 4), ROR with a 95% confidence interval (lower limit of 95% C.I. of ROR is greater than 1), and the number of cases of co-occurrence (n) were used for the identification of novel signals.

resultsA total of 13,918 cases of DRESS were reported, out of which 5,455 cases were found with various classes of antibiotics. The signal of DRESS was identified with a total of 40 antibiotics. Sub groups analysis results have shown variation in the strength of signal based on gender, age groups and geographical locations. The sensitivity analysis results have shown a decrease in the strength of signal after removal of cases of concomitant drugs.

conclusion22 antibiotics were identified which can be associated with DRESS; however, further causality assessment is required to confirm the association.

Indexed as

Adverse Drug Reaction Reporting SystemsAnti-Bacterial AgentsDrug Hypersensitivity SyndromeAdolescentAdultAgedChildChild, PreschoolDatabases, FactualFemaleHumansInfantMalePharmacovigilanceRetrospective StudiesUnited StatesAnti-Bacterial AgentsADRAntibioticsDRESS syndromeDrug-induced hypersensitivity syndromeFAERSSignal

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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.