Initial U.S. Approval: 1986
RECOMBIVAX HB is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus.
Apnea following intramuscular vaccination has been observed in some infants born prematurely.
Incidence Less Than 1% of Injections
– Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing
– Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite
– Rhinitis; influenza; cough
– Vertigo/dizziness; paresthesia
– Pruritus; rash (non-specified); angioedema; urticaria
– Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness
– Lymphadenopathy
– Insomnia/disturbed sleep
– Earache
– Dysuria
– Hypotension
Post-Marketing Experience
– Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. 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… Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.
– Elevation of liver enzymes; constipation
– Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell’s Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis
– Stevens-Johnson syndrome; alopecia; petechiae; eczema
– Arthritis; pain in extremity
– Increased erythrocyte sedimentation rate; thrombocytopenia
– Irritability; agitation; somnolence
– Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis
– Syncope; tachycardia
All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine.
RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility…