Safety of sildenafil in infants

The Food and Drug Administration issued a warning in 2012 against the use of sildenafil in pediatric patients (age 1 – 17). To assess safety concerns about sildenafil use  in infants, a review of published literature on this medication was conducted. Studies that included original data on the use of sildenafil in pulmonary hypertension were included. There were 49 studies identified, most of which were case series or case reports. None of the studies reported serious adverse effects in infants exposed to sildenafil, suggesting that the concern about adverse effects in pediatric patients may not apply to infants.

Safety of sildenafil in infants. Samiee-Zafarghandy et al, 2014.