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Background <p>Kounis syndrome (KS) is an acute coronary syndrome (ACS) triggered by allergic reactions and is frequently associated with antibiotic exposure. However, patient characteristics of antibiotic-associated KS cases are not well described. Some cases with KS-consistent symptoms may instead be reported as antibiotic-associated allergic coronary events (non-KS) without proper diagnosis. Characterizing these non-KS events may improve the accurate diagnosis of KS. This study explores the clinical features of antibiotic-associated KS and non-KS allergic coronary events in the FDA Adverse Event Reporting System (FAERS) and generates hypotheses regarding potential underdiagnosis and improved recognition of KS.</p> Methods <p>FAERS reports (September 2012–December 2024) were screened for allergic symptoms (SMQ: Anaphylactic reaction; Hypersensitivity) and ACS (SMQ: Acute myocardial infarction) with antibiotics listed as suspected drugs. After exclusions, 459 cases (KS: 205; non-KS: 254) were included. Extracted variables included demographics, comorbidities, drug use (ATC classification), and outcomes. Logistic regression identified factors independently associated with non-KS classification.</p> Results <p>Non-KS group exhibited higher rates of cardiac comorbidities, diabetes, and mortality (all <i>p</i> &lt; 0.05). Among suspected antibiotics, penicillins were the only class more frequently reported in KS cases (42% vs. 30%, <i>p</i> = 0.010). In the multivariable analysis, factors independently associated with non-KS classification included female sex (odds ratio [OR] = 1.804), fatal outcomes (OR = 4.320), and use of quinolones (OR = 11.108), aminoglycosides (OR = 3.480), renin–angiotensin agents (OR = 2.608), analgesics (OR = 2.055), and polypharmacy (OR = 3.314) (area under the curve = 0.815).</p> Conclusions <p>These exploratory findings indicate that non-KS allergic coronary events, characterized by higher comorbidities, mortality, and proportion of cases reporting the use of quinolones or aminoglycosides, may suggest a potential relationship between non-KS coronary events and KS underdiagnosis, warranting further prospective investigation.</p>

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Comparative clinical features of antibiotic-associated Kounis syndrome and non-Kounis allergic coronary events: a disproportionality analysis using U.S. Food and Drug Administration Adverse Event Reporting System

  • 期刊论文

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  • 发表日期：

    2026年2月3日

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  • Ichiro Nakakura,
  • Yutaro Mukai,
  • Atsuki Hosoda,
  • Naohiro Ohara,
  • Kaori Yamanishi,
  • Takaya Uno,
  • Satoshi Yokoyama,
  • Kouichi Hosomi,
  • Yoshiko Une

摘要

Background

Kounis syndrome (KS) is an acute coronary syndrome (ACS) triggered by allergic reactions and is frequently associated with antibiotic exposure. However, patient characteristics of antibiotic-associated KS cases are not well described. Some cases with KS-consistent symptoms may instead be reported as antibiotic-associated allergic coronary events (non-KS) without proper diagnosis. Characterizing these non-KS events may improve the accurate diagnosis of KS. This study explores the clinical features of antibiotic-associated KS and non-KS allergic coronary events in the FDA Adverse Event Reporting System (FAERS) and generates hypotheses regarding potential underdiagnosis and improved recognition of KS.

Methods

FAERS reports (September 2012–December 2024) were screened for allergic symptoms (SMQ: Anaphylactic reaction; Hypersensitivity) and ACS (SMQ: Acute myocardial infarction) with antibiotics listed as suspected drugs. After exclusions, 459 cases (KS: 205; non-KS: 254) were included. Extracted variables included demographics, comorbidities, drug use (ATC classification), and outcomes. Logistic regression identified factors independently associated with non-KS classification.

Results

Non-KS group exhibited higher rates of cardiac comorbidities, diabetes, and mortality (all p < 0.05). Among suspected antibiotics, penicillins were the only class more frequently reported in KS cases (42% vs. 30%, p = 0.010). In the multivariable analysis, factors independently associated with non-KS classification included female sex (odds ratio [OR] = 1.804), fatal outcomes (OR = 4.320), and use of quinolones (OR = 11.108), aminoglycosides (OR = 3.480), renin–angiotensin agents (OR = 2.608), analgesics (OR = 2.055), and polypharmacy (OR = 3.314) (area under the curve = 0.815).

Conclusions

These exploratory findings indicate that non-KS allergic coronary events, characterized by higher comorbidities, mortality, and proportion of cases reporting the use of quinolones or aminoglycosides, may suggest a potential relationship between non-KS coronary events and KS underdiagnosis, warranting further prospective investigation.