From the Guidelines
Sildenafil in neonates can cause several side effects, including headache, nasal congestion, flushing, agitation, hypotension, and vision and hearing loss.
Common Side Effects
- Headache
- Nasal congestion
- Flushing
- Agitation
- Hypotension
Less Common Side Effects
- Vision and hearing loss
- Priapism The dosing of sildenafil in neonates is typically 0.5–1 mg/kg 3 times daily orally, with a maximum dose of 10 mg 3 times daily orally for weight <20 kg 1. It is essential to delay the use of sildenafil in extremely preterm infants until retinal vascularization is established. The use of sildenafil in neonates with persistent pulmonary hypertension of the newborn (PPHN) is a reasonable adjunctive therapy, especially with an oxygenation index that exceeds 25 1. However, it is crucial to monitor these patients closely for potential side effects and adjust the treatment accordingly. The American Heart Association and American Thoracic Society guidelines recommend the use of sildenafil in pediatric patients with pulmonary hypertension, including neonates, with careful consideration of the potential risks and benefits 1.
From the Research
Side Effects of Sildenafil in Neonates
- The side effects of sildenafil in neonates have been studied in various research papers, with some studies reporting no clinically significant side effects 2, 3.
- However, other studies have reported systemic hypotension as a cause for concern 4.
- In one study, sildenafil was discontinued in one infant due to systemic hypotension, and it was combined with inhaled iloprost in two infants due to systemic hypotension and with inhaled nitric oxide in one infant due to deterioration 4.
- Another study reported that four infants were able to discontinue inhaled nitric oxide within 48 hours of sildenafil initiation, and no adverse events, such as hypotension or deaths, were reported in any of the seven infants 5.
- A systematic review and meta-analysis found that sildenafil exerted peak effects after 72 hours of treatment, and no clinically significant side effects were identified 2.
- Overall, the current evidence suggests that sildenafil may be effective in improving oxygenation in neonates with persistent pulmonary hypertension, but further studies are needed to assess the long-term side effects of this drug.
Specific Side Effects
- Systemic hypotension: reported in some studies as a cause for concern 4.
- No clinically significant side effects: reported in other studies 2, 3.
- Adverse events: reported in some studies, including discontinuation of sildenafil due to systemic hypotension and combination with other treatments due to deterioration 4.
- No adverse events: reported in other studies, including no hypotension or deaths 5.