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Label Changes for:

Revatio (sildenafil) Tablets and Injection

November 2010

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010




Pulmonary Hypertension Secondary to Sickle Cell Anemia
  • In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Revatio than by those randomized to placebo. The effectiveness of Revatio in PH secondary to sickle cell anemia has not been established.


  • Vaso-occlusive crisis