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. 2025 May 19;8(5):e70835.
doi: 10.1002/hsr2.70835. eCollection 2025 May.

Drug-Related Side Effects and Contributing Risk Factors in Children With Congenital Heart Disease: A Cross-Sectional Study

Esmaeel Toni  1 , Haleh Ayatollahi  2 , Reza Abbaszadeh  3 , Alireza Fotuhi Siahpirani  4
Affiliations

Drug-Related Side Effects and Contributing Risk Factors in Children With Congenital Heart Disease: A Cross-Sectional Study

Esmaeel Toni et al. Health Sci Rep. .

Abstract

Background and aims: Children with congenital heart disease (CHD) often require complex pharmacotherapy for symptom management and complication prevention. However, their unique physiological profiles increase vulnerability to drug-related side effects. This study aimed to identify specialists' perspectives on drug-related side effects and associated risk factors in pediatric CHD patients.

Methods: A cross-sectional study was conducted in 2024 involving 20 pediatric cardiologists and pediatric cardiology fellows. Data were collected using two 5-point Likert scale questionnaires assessing commonly prescribed drugs, observed side effects, and associated risk factors in pediatric CHD patients. Data were analyzed using student's t-tests and descriptive statistics.

Results: According to the findings, the most frequent side effects linked to common medications were hypokalemia (Furosemide; 4.5 ± 0.69), apnea (Prostaglandin E1; 4.5 ± 0.62), and bradycardia (Sotalol; 4.41 ± 0.51). Dosage and polypharmacy emerged as major risk factors, particularly for drugs like Digoxin and Heparin. Younger age, underlying health conditions, and specific drug combinations also increased the risk of side effects. The t-test revealed significant associations between participants' demographics (sex, age, and work experience) and their perceptions of drug-related side effects and risk factors.

Conclusions: The findings emphasize the need for a personalized approach to pharmacotherapy in pediatric CHD patients, requiring careful drug selection, dose optimization, and enhanced monitoring strategies. Drug-related side effects highlight the importance of implementing clinical decision support systems, routine therapeutic drug monitoring, and individualized dosing adjustments to mitigate risks. Future research should prioritize longitudinal studies to establish causality relationships, optimize treatment protocols, and improve medication safety in this vulnerable population.

Keywords: children; congenital heart disease; drug‐related side effects; risk factors.

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Conflict of interest statement

The authors declare no conflicts of interest.

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