Biothrax Side Effects

Please note - some side effects for Biothrax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

Local

Local side effects are reported most commonly and have included tenderness, erythema, subcutaneous nodule, induration, warmth, local pruritus, arm motion limitation, and edema. Local reactions tended to occur more often in females.

Severe local reactions defined as edema or induration >120 mm diameter , marked arm motion limitation, or marked axillary node tenderness have been reported in 0.15% of vaccinees (n=15,907). Moderate local reactions defined as edema or induration 30 mm to 120 mm have been reported in 0.94%. Mild reactions have been reported in 8.63%.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, and vomiting.

Musculoskeletal

Musculoskeletal side effects have included transient myalgia and arthralgia. Inflammatory arthritis has rarely been reported; however, causality has not been established.

Other

Systemic reactions have included transient headache, fever, fatigue, malaise, and chills. In post-licensure studies, systemic reactions were reported in 5% to 35% of vaccinees and occurred more often in women.

Respiratory

Respiratory side effects have included transient respiratory difficulty. Asthma has been reported rarely; however, causality has not been established.

Hypersensitivity

One case of delayed hypersensitivity has been reported. A vaccinee developed lesions by day 3 after the first dose, diffuse hives by day 17 (3 days after the second dose), and swollen hands, face, and feet, and discomfort swallowing by day 18.

Hypersensitivity reactions have included delayed hypersensitivity and anaphylaxis.

Nervous system

Nervous system side effects have included dizziness. Seizure, tremors, aseptic meningitis, encephalitis, transverse myelitis, cerebrovascular accident, facial palsy, hearing and visual disorders, Guillain-Barre Syndrome, and multiple sclerosis have been reported rarely; however, causality has not been established.

Dermatologic

Dermatologic side effects have included pruritus. Cysts, pemphigus vulgaris, and cellulitis have rarely been reported; however, causality has not been established.

Other

Other side effects have rarely included sepsis, systemic lupus erythematosus, polyarteritis nodosa, and spontaneous abortion; however, causality has not been established.

Hematologic

Hematologic side effects have rarely included aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia; however, causality has not been established.

Psychiatric

Psychiatric side effects have rarely included mental status changes, psychiatric disorders, and mood-cognition disorders; however, causality has not been established.

Cardiovascular

Cardiovascular side effects have rarely included myocarditis, cardiomyopathy, atrial fibrillation, syncope, endocarditis, angioedema, and collagen vascular disease; however, causality has not been established.

Hepatic

Hepatic side effects have rarely included liver abscess; however, causality has not been established.

Renal

Renal side effects have rarely included glomerulonephritis and renal failure; however, causality has not been established.

Immunologic

Immunologic side effects have rarely included immune deficiency; however, causality has not been established.

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