Black Box Warning

Fetal toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potentially reversible neonatal renal failure, hypotension, and hyperkalemia may occur. Observe infants with histories of in utero exposure to fosinopril for hypotension, oliguria, and hyperkalemia. If oliguria occurs, support blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.