Most concerning short-term adverse effects: Worsening oxygenation and systemic hypotension.
Epistaxis, respiratory symptoms (cough and nasal congestion), diarrhoea and vomiting, gastroesophageal reflux and abdominal pain, headaches, tremors, erections, facial flushing, dizziness, irritability and (rarely) fever, skin disorders, pain in limbs and oedema have been reported in children on sildenafil. The Sildenafil in Treatment-Naïve Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension long-term extension (STARTS-2) trial showed worse survival in children receiving high doses of sildenafil as monotherapy.2 A recent study conducted by Roldan and colleagues, found there was a statistically significant increase in adverse drug reaction (ADR) frequency in children receiving higher-than-recommended doses. However, it was not associated with a lower survival rate.14
Sildenafil has the potential to adversely affect vision.13
Impaired liver function tests.
May increase the risk of severe retinopathy of prematurity if used in extremely preterm neonates.
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