Immune globulin intravenous (IGIV) is a sterile, highly purified immunoglobulin G (IgG) preparation made from pooled human plasma stabilized with glucose, maltose, glycine, sucrose, sorbitol, or albumin and is used as prophylaxis or therapy for various medical disorders. The Food and Drug Administration (FDA) first licensed IGIV in 1981 and has approved its use for six conditions: primary immunodeficiencies, immune-mediated thrombocytopenia, Kawasaki syndrome, recent bone marrow transplantation in patients aged > or =20 years, chronic B-cell lymphocytic leukemia, and pediatric human immunodeficiency virus type 1 (HIV-1) infection. In clinical practice, IGIV has been known to be used to treat 50-60 unapproved conditions, including acute lymphoblastic leukemia, adult HIV infection, multiple sclerosis, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyneuropathy. During June 1985-November 1998, FDA received approximately 120 reports worldwide of renal adverse events (RAEs) (i.e., acute renal failure or insufficiency) following IGIV administration. This report describes the epidemiology of IGIV-associated RAEs in the United States and emphasizes the importance of reviewing indications for IGIV use and implementing precautions during its administration.