RabAvert Side Effects

Please note - some side effects for RabAvert 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 of RabAvert - for the Consumer

RabAvert

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using RabAvert:

Chills; dizziness; general body discomfort; headache; itching; mild fever; stomach pain; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty swallowing; hoarseness; joint or muscle pain; numbness or tingling; pain, redness, or swelling at the injection site; paralysis.

Side Effects by Body System

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, type III hypersensitivity-like reactions, bronchospasm, urticaria, pruritus, and edema.

Nervous system

Nervous system side effects have included dizziness, transient paresthesias, neuroparalysis, encephalitis, meningitis, transient paralysis, Guillain-Barre syndrome, myelitis, retrobulbar neuritis, multiple sclerosis, vertigo, and visual disturbance. The use of corticosteroids to treat life-threatening neuroparalytic reactions may inhibit the development of immunity to rabies.

Local

Local side effects have included injection site erythema, induration, pain, itching, and extensive limb swelling.

Cardiovascular

Cardiovascular side effects have included palpitations and hot flush.

Gastrointestinal

Gastrointestinal side effects have included nausea.

Dermatologic

Dermatologic side effects have included rash and one case of suspected urticaria pigmentosa.

Musculoskeletal

Musculoskeletal side effects have included myalgia, arthralgia, and monoarthritis.

Other

Other side effects have included flu-like symptoms such as asthenia, fatigue, fever, headache, myalgia, and malaise; and lymphadenopathy, sweating, and chills.

General

The most common side effects have included local injection site reactions in up to 45% of patients. The most common systemic reactions have included malaise, headache, and dizziness in up to 25% of patients. Rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic reactions. These reactions usually can be managed with antipyretics and anti-inflammatories.

The risk of developing a potentially fatal rabies infection should be considered before making the decision to discontinue rabies vaccination when severe anaphylactic or neuroparalytic reactions occur. The State Health Department or Centers for Disease Control and Prevention may be consulted for advice on managing serious reactions.

Adverse reactions should be reported to the U.S. Department of Health and Human Services Vaccine Adverse Event Reporting System. Reporting forms and information regarding the completion of the form can be obtained at 1-800-822-7967 (USA).

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