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  • Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment.

  • Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.5), Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.3)].

FDA and Industry Communications

Omalizumab (marketed as Xolair) Information: FDA Information Page

Information for Healthcare Professionals: Olizaumab (marketed as Xolair) (Feburary 2007)

Black Box Proposal: February 2007 Black Box Finalization

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Additional Information

Updated May 2021