Initial U.S. Approval: 1989
ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
Apnea following intramuscular vaccination has been observed in some infants born prematurely.
Incidence <1% of Injections
– Upper respiratory tract illnesses.
– Lymphadenopathy.
– Anorexia.
– Agitation, insomnia.
– Somnolence, tingling.
– Flushing, hypotension.
– Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting.
– Erythema, petechiae, pruritus, rash, sweating, urticaria.
– Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck.
– Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness.
Serious adverse events (SAEs) occurred in 3.8% of diabetic subjects and 1.6% of controls.
Postmarketing Experience
– Herpes zoster, meningitis.
– Thrombocytopenia.
– Allergic reaction, anaphylactoid reaction, anaphylaxis. An apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum.
– Encephalitis; encephalopathy; migraine; multiple sclerosis; neuritis; neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy; optic neuritis; paralysis; paresis; seizures; syncope; transverse myelitis.
– Conjunctivitis, keratitis, visual disturbances.
– Earache, tinnitus, vertigo.
– Palpitations, tachycardia.
– Vasculitis.
– Apnea, bronchospasm including asthma-like symptoms.
– Dyspepsia.
– Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura.
– Arthritis, muscular weakness.
– Injection site reaction.
– Abnormal liver function tests.
Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg [Hepatitis B surface Antigen] adsorbed on 0.25 mg aluminum as aluminum hydroxide.
Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide.
ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.