RECOMBIVAX HB and RECOMBIVAX HB Dialysis Formulation are generally well-tolerated. No serious adverse reactions attributable to the vaccine have been reported during the course of clinical trials. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever (≥101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.¹⁰ In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, and nodule formation.

The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); and malaise.

Nausea; and diarrhea

Pharyngitis; and upper respiratory infection

Sweating; achiness; sensation of warmth; lightheadedness; chills; and flushing

Vomiting; abdominal pains/cramps; dyspepsia; and diminished appetite

Rhinitis; influenza; and cough

Vertigo/dizziness; and paresthesia

Pruritus; rash (non-specified); angioedema; and urticaria

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; and neck stiffness

Lymphadenopathy

Insomnia/disturbed sleep

Earache

Dysuria

Hypotension

The following additional adverse reactions have been reported with use of the marketed vaccine. In many instances, the relationship to the vaccine was unclear.

Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode 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 (see WARNINGS and PRECAUTIONS).

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

Arthritis

Increased erythrocyte sedimentation rate; thrombocytopenia

Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis

Irritability; agitation; somnolence

Optic neuritis; tinnitus; conjunctivitis; visual disturbances

Syncope; tachycardia.

The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.

Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.³²

There are no known drug interactions. (See INDICATIONS AND USAGE, Use with Other Vaccines.)

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