Biothrax Side Effects

Generic Name: anthrax vaccine adsorbed

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

Not all side effects for Biothrax may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to anthrax vaccine adsorbed: suspension

Along with its needed effects, anthrax vaccine adsorbed (the active ingredient contained in Biothrax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking anthrax vaccine adsorbed:

More common
  • Pain, redness, tenderness, or limited movement of the arm where the injection is given
Less common
  • Swollen, painful, or tender lymph glands in the neck, armpit, or groin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • hives or welts
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • sores, ulcers, or white spots in the mouth or on the lips
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness

Some side effects of anthrax vaccine adsorbed may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
  • muscle aches and pains
Incidence not known
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dark-colored urine
  • difficulty with moving
  • feeling of warmth
  • hair loss or thinning of the hair
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • swollen joints
  • trouble sleeping

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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