Does Recombivax HB (hepatitis B vaccine) cause side effects?
Recombivax HB is made from noninfectious parts of HBV using recombinant DNA technology. The vaccine is a sterile preparation for intramuscular injection and contains purified inactive proteins from the surface of HBV.
The proteins can activate the immune system but cannot give rise to a replicating virus. Viral proteins used in Recombivax HB are manufactured in yeast cells (S. cerevisiae) using recombinant technology. Recombivax HB works by stimulating the immune system to attack the viral proteins.
When Recombivax HB is administered, the body's immune system recognizes the viral proteins in the vaccine as foreign, and develops antibodies against them, thus providing immunity from future infections. In the event of HBV exposure following vaccination, the body will already be primed to fight the infection.
Common side effects of Recombivax HB include
- reduced appetite,
- cold symptoms,
- injections site reactions,
- back pain,
- muscle pain,
- joint pain,
- difficulty sleeping,
- ringing in the ears,
- constipation, and
- taste changes.
Serious side effects of Recombivax HB include
Drug interactions of Recombivax HB include fingolimod, belimumab, anakinra, adalimumab, infliximab, antineoplastic agents (anti-cancer medications), and other immunosuppressives, which may decrease the effectiveness of Recombivax HB.
There are no adequate or well-controlled trials of Recombivax HB use in pregnant women. Recombivax HB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What are the important side effects of Recombivax HB (hepatitis B vaccine)?
Common side effects of HBV vaccines include:
Other reported side effects include:
Recombivax HB (hepatitis B vaccine) side effects list for healthcare professionals
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
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
- fever ( ≥ 101°F oral equivalent),
- diminished appetite, and
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
The most frequent systemic complaints include
Respiratory, Thoracic And Mediastinal Disorders
Incidence Less Than 1% of Injections
General Disorders And Administration Site Conditions
Respiratory, Thoracic And Mediastinal Disorders
Nervous System Disorders
Skin And Subcutaneous Tissue Disorders
Musculoskeletal And Connective Tissue Disorders
Blood And Lymphatic Disorders
Ear And Labyrinth Disorders
Renal And Urinary Disorders
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
- Autoimmune diseases including
Nervous System Disorders
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
Skin and Subcutaneous Disorders
Musculoskeletal and Connective Tissue Disorders
Pain in extremity
Blood and Lymphatic System Disorders
What drugs interact with Recombivax HB (hepatitis B vaccine)?
Concomitant Administration With Other Vaccines
- Do not mix Recombivax HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.
- In clinical trials in children, Recombivax HB was concomitantly administered with one or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of Diphtheria, Tetanus, acellular Pertussis. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.
- In another clinical trial, a related HBsAg-containing product, Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or Varivax [Varicella Virus Vaccine Live (Oka/Merck)], using separate sites and syringes for injectable vaccines. No serious vaccine-related adverse events were reported, and no impairment of immune response to these individually tested vaccine antigens was demonstrated.
- Comvax has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.
Concomitant Administration With Immune Globulin
- Recombivax HB may be administered concomitantly with HBIG. The first dose of Recombivax HB may be given at the same time as HBIG, but the injections should be administered at different sites.
Recombivax HB (hepatitis B vaccine) is used to prevent hepatitis B infection, a serious liver infection caused by the hepatitis B virus (HBV). Common side effects of Recombivax HB include irritability, fever, diarrhea, fatigue, weakness, reduced appetite, cold symptoms, headache, injections site reactions, flushing, back pain, muscle pain, joint pain, rash, difficulty sleeping, dizziness, ringing in the ears, constipation, and taste changes. Recombivax HB should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Recombivax HB is excreted into breast milk after administration to the mother.
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Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Hepatitis A (HAV, Hep A)
Hepatitis means inflammation of the liver. Hepatitis A (HAV, Hep A) is one type of liver disease caused by a virus. Since hepatitis A is a virus, it can pass from person to person from eating or drinking contaminated food or coming into contact with contaminated materials containing the virus. Symptoms of hepatitis A include stomach pain, diarrhea, dark yellow urine, jaundice, and more. There is a vaccine to prevent contracting hepatitis A.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by persons sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
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Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
What Causes Hepatitis?
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.