Biothrax Side Effects

Generic name: anthrax vaccine adsorbed

Note: This document contains side effect information about anthrax vaccine adsorbed. Some of the dosage forms listed on this page may not apply to the brand name Biothrax.

Some side effects of Biothrax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to anthrax vaccine adsorbed: subcutaneous suspension

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction while taking anthrax vaccine adsorbed (the active ingredient contained in Biothrax) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect (some are rare but serious) such as:

• severe swelling or a hard lump where the shot was given;

• severe swelling spreading to other parts of your arm;

• fever, chills, body aches, nausea, flu symptoms;

• pale skin, easy bruising or bleeding;

• confusion, changes in mood or behavior;

• seizure (convulsions);

• blistering, redness, and swelling or warmth of the skin;

• weakness, numbness or tingly feeling in your feet spreading upward;

• problems with vision, hearing, speech, swallowing, or bladder and bowel functions;

• severe lower back pain; or

• slow heart rate, trouble breathing, weak pulse, or feeling like you might pass out.

Less serious side effects include:

• mild redness, warmth, itching, or tenderness where the shot was given;

• low fever;

• feeling tired or weak;

• headache, dizziness;

• mild pain or stiffness in the injected arm;

• joint or muscle pain;

• swelling in your hands or feet; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to anthrax vaccine adsorbed: subcutaneous suspension

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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