Medical Editor: John P. Cunha, DO, FACOEP
Recombivax [hepatitis b vaccine (recombinant)] is a viral vaccine used to help prevent the disease Hepatitis B. Common side effects of Recombivax include:
- irritability (especially in children),
- injection site reactions (pain, soreness, redness, swelling),
- fever,
- headache,
- tiredness,
- sore throat,
- runny or stuffy nose,
- nausea,
- diarrhea,
- loss of appetite,
- fatigue,
- weakness, and
- dizziness.
Tell your doctor if you have infrequent and temporary symptoms soon after receiving an injection of Recombivax, including:
- fainting,
- dizziness,
- lightheadedness,
- vision changes,
- numbness and tingling, or
- seizure-like movements.
The dose of Recombivax is a vaccination regimen of 3 doses of vaccine given according to the following schedule: First dose: at elected date; Second dose: 1 month later; Third dose: 6 months after the first dose. Adolescents 11 to 15 years may follow a 2 dose regimen. Recombivax may interact with other recent vaccines, steroid medicines, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications you use. During pregnancy, Recombivax should be used only when prescribed. It is unknown whether this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Recombivax [hepatitis b vaccine (recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.
Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.
Read the entire patient information overview for Recombivax (Hepatitis B Vaccine (Recombinant))
SIDE EFFECTS
In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
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 adverse reactions 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.
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 adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:
Incidence Equal To or Greater Than 1% of Injections
General Disorders And Administration Site Conditions
Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.
The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); malaise.
Gastrointestinal Disorders
Nausea; diarrhea
Respiratory, Thoracic And Mediastinal Disorders
Pharyngitis; upper respiratory infection
Incidence Less Than 1% of Injections
General Disorders And Administration Site Conditions
Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing
Gastrointestinal Disorders
Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite
Respiratory, Thoracic And Mediastinal Disorders
Rhinitis; influenza; cough
Nervous System Disorders
Vertigo/dizziness; paresthesia 5
Skin And Subcutaneous Tissue Disorders
Pruritus; rash (non-specified); angioedema; urticaria
Musculoskeletal And Connective Tissue Disorders
Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness
Blood And Lymphatic Disorders
Psychiatric Disorders
Insomnia/disturbed sleep
Ear And Labyrinth Disorders
Renal And Urinary Disorders
Cardiac Disorders
Post-Marketing Experience
The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.
Immune System Disorders
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 [see WARNINGS AND PRECAUTIONS]. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.
Gastrointestinal Disorders
Elevation of liver enzymes; constipation
Nervous System Disorders
Guillain-Barr� 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
Skin and Subcutaneous Disorders
Stevens-Johnson syndrome; alopecia; petechiae; eczema
Musculoskeletal and Connective Tissue Disorders
Arthritis
Pain in extremity
Blood and Lymphatic System Disorders
Increased erythrocyte sedimentation rate; thrombocytopenia
Psychiatric Disorders
Irritability; agitation; somnolence
Eye Disorders
Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis
Cardiac Disorders
The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.
Read the entire FDA prescribing information for Recombivax (Hepatitis B Vaccine (Recombinant))
Read the Recombivax User Reviews »
© Recombivax Patient Information is supplied by Cerner Multum, Inc. and Recombivax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
