Omalizumab (marketed as Xolair) Information
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, using the contact information at the bottom of this page.
Healthcare Professional Information
- FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
- Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)
- Information for Healthcare Professionals: Omalizumab (marketed as Xolair)
- Xolair Regulatory History and Labeling from Drugs@FDA
- Xolair Medication Guide