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Important Safety Information

Afluria^® is indicated for active immunization of persons 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria^®; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria^®.

Afluria^® should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria^®, or to anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness, and swelling. The most common systemic adverse reactions were headache, malaise, and muscle aches.

Vaccination with Afluria^® may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Afluria^® should be based on careful consideration of the potential benefits and risks.

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