Clinical profile of oxcarbazepine-related angioneurotic edema: case report and review.

Oxcarbazepine, a carbamazepine analog, was approved for use as an antiepileptic agent in the United States in 2000. A search of the United States Food and Drug Administration's Adverse Event Reporting System identified nine cases of oxcarbazepine-associated angioedema in pediatric patients aged 16 years and younger. We describe in detail the first U.S. case report, of a 4(1/2)-year-old boy who experienced angioedema during treatment with oxcarbazepine. The reporting rate for angioedema was calculated to be 9.8 cases per 1,000,000 pediatric patients. Oxcarbazepine-associated angioedema manifested by swelling of the face, eyes, lips, or tongue or difficulty swallowing or breathing (or both) is a rare but potentially life-threatening reaction for which early recognition and management are vital.