According to the package insert, common adverse reactions following CYFENDUS include redness, swelling, and pain at the injection site, arm motion limitation, muscle aches, fever, fatigue, and headache.
Serious adverse events reported during pre-licensing clinical trials of CYFENDUS include Ulcerative Colitis, diffuse alopecia, spontaneous urticaria, acute cholecystitis, spontaneous abortion, pre-term premature rupture of membranes resulting in fetal death, Graves’ disease, autoimmune thyroiditis, celiac disease, Polymyalgia rheumatica, Psoriatic arthropathy, Systemic lupus erythematosus, Subacute cutaneous lupus erythematosus, Guttate psoriasis, Alopecia areata, and death.
No post-marketing data is available on adverse events associated with CYFENDUS; however, the manufacturer reports that the post-marketing experience of Biothrax anthrax vaccine is relevant since both vaccines have similar manufacturing practices. CYFENDUS, however, contains the CPG 7909 adjuvant, which is not found in Biothrax.
