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Background and objective: Sildenafil has been used off-label for treatment pulmonary arterial hypertension associated with congenital heart disease (APAH-CHD) in pediatric patients but it is not approved by United States Food and Drug Administration (USFDA) and Thai Food and Drug Administration in the pediatric population. Thus, this study aimed to investigate the adverse drug reactions of sildenafil for the treatment of APAH-CHD in pediatric patients.
Methods: This study was a retrospective study in children under 18 years old with APAH-CHD who receiving sildenafil treatment at Queen Sirikit Heart Center of the Northeast, Khon Khan University during January 2009 to December 2014. Adverse drug reactions, duration of treatment and dosing of sildenafil data were collected by chart review.
Results: There were 112 patients included in the study. There were 8 patients (7.1%) with 8 adverse drug events reported during the treatment period, headache in 5 patients and epistaxis in 3 patients.
Conclusions: The use of sildenafil seems to be safe in the treatment of APAH-CHD in children under 18 years old. The common ADRs were headache and epistaxis without any serious adverse event reported.
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