Mining and analysis of drug-induced shock adverse reactions: A comprehensive pharmacovigilance study based on the US FAERS database
Abstract
BACKGROUND: Shock is a life-threatening clinical condition characterized by high morbidity and mortality. Drug-induced shock represents a complex subset of adverse drug reactions that has not been systematically investigated on a large scale. Comprehensive pharmacovigilance analyses are needed to identify high-risk drugs and drug combinations.
METHOD: We conducted a retrospective pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) covering the period from 2004Q1 to 2024Q2. Shock-related events were extracted using standardized MedDRA preferred terms. Data deduplication followed FDA guidelines, and four complementary signal detection methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM)-were applied. Drug classification was performed using the Anatomical Therapeutic Chemical (ATC) system, and drug-drug interaction analysis was carried out with the Ω shrinkage method.
RESULT: The initial dataset contained 3,611,216 duplicate records, and after deduplication, 17,947,720 demographic records were retained. From these, 8,511,840 records reported by healthcare professionals were included, yielding 277,956 shock-related adverse event reports involving 244,030 patients. Among these patients, 46.38% were female, 43.09% were male, and 10.53% had unspecified gender, while the main age groups were 45-64 years (27.35%) and ≥65 years (27.82%). Geographically, the United…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 244,030 participants or records.
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