Engerix-B Side Effects

Generic Name: hepatitis b vaccine

Please note - some side effects for Engerix-B 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 Engerix-B - for the Consumer

Engerix-B

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 Engerix-B:

Diarrhea; dizziness; fatigue; general feeling of discomfort; headache; irritability; loss of appetite; mild fever or sore throat; nausea; pain, swelling, or redness at the injection site; runny nose; tiredness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Side Effects by Body System

General

Hepatitis B vaccine is generally well-tolerated. Most side effects were mild and primarily included injection site reactions and fatigue.

Respiratory

Respiratory side effects have included rhinitis, cough, pharyngitis, upper respiratory tract illness, influenza-like symptoms, and bronchospasm including asthma-like symptoms.

Other

Other side effects have included fatigue, fever, chills, flushing, lightheadedness, sweating, weakness, malaise, tinnitus, and earache.

Ocular

Ocular side effects have included optic neuritis, conjunctivitis, keratitis, and visual disturbances.

Nervous system

Nervous system side effects have included headache, dizziness, vertigo, somnolence, insomnia, irritability, agitation, migraine, syncope, paresis, neuropathy, hypoesthesia, paresthesia, convulsions, encephalitis, Guillain-Barre syndrome, radiculopathy, herpes zoster, muscle weakness, multiple sclerosis, exacerbation of multiple sclerosis, Bell's palsy, optic sclerosis, myelitis, and transverse myelitis.

Musculoskeletal

Musculoskeletal side effects have included arthritis, arthralgia, myalgia, back pain, and pain or stiffness in the arm, shoulder, or neck.

Local

Local side effects have included soreness, redness, swelling, induration, pain, pruritus, warmth, nodule formation, and ecchymosis at the injection site.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, anaphylactoid reactions, rash, pruritus, urticaria, edema, dyspnea, chest discomfort, bronchial spasm, palpitation, hypotension, erythema multiforme, Stevens-Johnson syndrome, angioedema, arthritis, and serum sickness-like syndrome (arthralgia, arthritis, fever, urticaria, erythema multiforme, ecchymoses, and erythema nodosum).

Hepatic

Hepatic side effects have included abnormal liver function tests.

Hematologic

Hematologic side effects have included lymphadenopathy, thrombocytopenia, and increased erythrocyte sedimentation rate.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal pain, cramps, anorexia, constipation, and dyspepsia.

Dermatologic

Dermatologic side effects have included rash, urticaria, petechiae, erythema, hyperhidrosis, angioedema, eczema, herpes zoster, erythema nodosum, purpura, alopecia, and Stevens-Johnson syndrome.

Cardiovascular

Cardiovascular side effects have included syncope, hypotension, tachycardia, and palpitations.

Immunologic

Immunologic side effects have included systemic lupus erythematosus, lupus-like syndrome, and vasculitis.

Genitourinary

Genitourinary side effects have included dysuria.

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