Does Twinrix (hepatitis A/B vaccine) cause side effects?
Twinrix (hepatitis A/B vaccine) is a man-made combination vaccine containing an inactivated hepatitis A virus strain and non-infectious hepatitis B virus surface antigen. Inactive Hepatitis A virus combined with hepatitis B antigens stimulates the immune system to develop immunity against hepatitis A and B virus infections.
Common side effects of Twinrix include
- injection site soreness and pain,
- fainting, and
- allergic reactions in latex-sensitive people.
Serious side effects of Twinrix include
- serious allergic reactions,
- abnormal heartbeats, and
- hair loss.
Drug interactions of Twinrix include medications and therapies that suppress the immune system such as
- irradiation, and
- high doses of steroids, because suppressing the immune system reduces the effectiveness of Twinrix.
There are no adequate studies done on Twinrix to determine safe and effective use in pregnant women. Twinrix should be given to pregnant women only if clearly needed.
What are the important side effects of Twinrix (hepatitis A/B vaccine)?
Side effects of hepatitis A/B vaccine are
The tip caps of pre-filled syringes may contain latex which can cause allergic reactions in latex-sensitive people.
Twinrix (hepatitis A/B vaccine) side effects list for healthcare professionals
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 with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
Following any dose of Twinrix, the most common (≥10%) solicited injection site reactions were
- injection site soreness (35% to 41%) and redness (8% to 11%);
- the most common solicited systemic adverse reactions were
The safety of Twinrix has been evaluated in clinical trials involving the administration of approximately 7,500 doses to more than 2,500 individuals.
- In a U.S. study, 773 subjects (aged 18 to 70 years) were randomized 1:1 to receive Twinrix (0-, 1-, and 6-month schedule) or concurrent administration of Engerix-B (0-, 1-, and 6-month schedule) and Havrix (0- and 6-month schedule).
- Solicited local adverse reactions and systemic adverse events were recorded by parents/guardians on diary cards for 4 days (Days 0 to 3) after vaccination.
- Unsolicited adverse events were recorded for 31 days after vaccination.
- Solicited reactions reported following the administration of Twinrix or Engerix-B and Havrix are presented in Table 1.
Table 1: Rates of Local Adverse Reactions and Systemic Adverse Reactions within 4 Days of Vaccinationa with Twinrixb or Engerix-B and Havrixc
|Dose 1||Dose 2||Dose 3||Dose 1||Dose 2||Dose 3||Dose 1||Dose 2|
|(n=385) %||(n=382) %||(n = 374) %||(n = 382) %||(n = 376)%||(n = 369)%||(n = 382)%||(n = 369) %|
|Twinrix||Engerix-B and Havrix|
|Dose 1||Dose 2||Dose 3||Dose 1d||Dose 2e||Dose 3d|
|(n = 385) %||(n = 382) %||(n = 374) %||(n = 382) %||(n = 376)%||(n = 369) %|
|a Within 4 days of vaccination defined as day of vaccination and the next 3 days.|
b 389 subjects received at least 1 dose of Twinrix.
c 384 subjects received at least 1 dose each of Engerix-B and Havrix.
d Doses 1 and 3 included Engerix-B and Havrix in the control group receiving separate vaccinations.
e Dose 2 included only Engerix-B in the control group receiving separate vaccinations.
Most solicited local adverse reactions and systemic adverse reactions seen with Twinrix were considered by the subjects as mild and self-limiting and did not last more than 48 hours.
In a clinical trial in which Twinrix was given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months, solicited local adverse reactions or systemic adverse reactions were comparable to those seen in other clinical trials of Twinrix given on a 0-, 1-, and 6-month schedule.
Among 2,299 subjects in 14 clinical trials, the following adverse reactions were reported to occur within 30 days following vaccination:
Incidence 1% To 10% Of Injections, Seen In Clinical Trials With Twinrix
- Infections and Infestations: Upper respiratory tract infections.
- General Disorders and Administration Site Conditions: Injection site induration.
Incidence <1% Of Injections, Seen In Clinical Trials With Twinrix
- Infections and Infestations: Respiratory tract illnesses.
- Metabolism and Nutrition Disorders: Anorexia.
- Psychiatric Disorders: Agitation, insomnia.
- Nervous System Disorders: Dizziness, migraine, paresthesia, somnolence, syncope.
- Ear and Labyrinth Disorders: Vertigo.
- Vascular Disorders: Flushing.
- Gastrointestinal Disorders: Abdominal pain, vomiting.
- Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, rash, sweating, urticaria.
- Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia.
- General Disorders and Administration Site Conditions: Injection site ecchymosis, injection site pruritus, influenza-like symptoms, irritability, weakness.
Incidence <1% Of Injections, Seen In Clinical Trials With Havrix And/Or Engerix-B
- Blood and Lymphatic System Disorders: Lymphadenopathy.a+b
- Nervous System Disorders: Dysgeusia,a hypertonia,a tingling.b
- Eye Disorders: Photophobia.a
- Vascular Disorders: Hypotension.b
- Gastrointestinal Disorders: Constipation.b
- Investigations: Creatine phosphokinase increased.a
a+b Following either Havrix or Engerix-B.
a Following Havrix.
b Following Engerix-B.
Adverse reactions within 30 days of vaccination in the U.S. clinical trial of Twinrix given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months were comparable to those reported in other clinical trials.
The following adverse reactions have been identified during post-approval use of Twinrix, Havrix, or Engerix-B. 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 the vaccine.
Postmarketing Experience With Twinrix
- Infections and Infestations: Herpes zoster, meningitis.
- Blood and Lymphatic System Disorders: Thrombocytopenia, thrombocytopenic purpura.
- Immune System Disorders: Allergic reaction, anaphylactoid reaction, anaphylaxis, serum sickness-like syndrome days to weeks after vaccination (including arthralgia/arthritis, usually transient; fever; urticaria; erythema multiforme; ecchymoses; and erythema nodosum).
- Nervous System Disorders: Bell's palsy, convulsions, encephalitis, encephalopathy, Guillain-Barre syndrome, hypoesthesia, myelitis, multiple sclerosis, neuritis, neuropathy, optic neuritis, paralysis, paresis, transverse myelitis.
- Eye Disorders: Conjunctivitis, visual disturbances.
- Ear and Labyrinth Disorders: Earache, tinnitus.
- Cardiac Disorders: Palpitations, tachycardia.
- Vascular Disorders: Vasculitis.
- Respiratory, Thoracic, and Mediastinal Disorders: Bronchospasm, including asthma-like symptoms; dyspnea.
- Gastrointestinal Disorders: Dyspepsia.
- Hepatobiliary Disorders: Hepatitis, jaundice.
- Skin and Subcutaneous Tissue Disorders: Alopecia, angioedema, eczema, erythema multiforme, erythema nodosum, hyperhidrosis, lichen planus.
- Musculoskeletal and Connective Tissue Disorders: Arthritis, muscular weakness.
- General Disorders and Administration Site Conditions: Chills; immediate injection site pain, stinging, and burning sensation; injection site reaction; malaise.
- Investigations: Abnormal liver function tests.
Postmarketing Experience With Havrix And/Or Engerix-B
The following list includes adverse reactions for Havrix and/or Engerix-B not already reported above for Twinrix.
Eye Disorders: Keratitis.a
- Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome.a
- Congenital, Familial, and Genetic Disorders: Congenital abnormality.b
a Following Engerix-B.
b Following Havrix.
What drugs interact with Twinrix (hepatitis A/B vaccine)?
Concomitant Administration With Vaccines And Immune Globulin
- Do not mix Twinrix with any other vaccine or product in the same syringe.
- When concomitant administration of immunoglobulin is required, it should be given with a different syringe and at a different injection site.
- There are no data to assess the concomitant use of Twinrix with other vaccines.
- Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater-than-physiologic doses), may reduce the immune response to Twinrix.
Interference With Laboratory Tests
Twinrix (hepatitis A/B vaccine) is a man-made combination vaccine containing an inactivated hepatitis A virus strain and non-infectious hepatitis B virus surface antigen. Common side effects of Twinrix include injection site soreness and pain, headache, fatigue, redness, diarrhea, nausea, fainting, and allergic reactions in latex-sensitive people. There are no adequate studies done on Twinrix to determine safe and effective use in pregnant women. It is unknown if Twinrix enters breast milk.
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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)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
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?
Hepatitis is inflammation of the liver. It can occur due to a variety of factors, but the most common cause is a virus infection. The types of hepatitis are hepatitis A, B, C, D, and E. Hepatitis can be acute (short-term) or chronic (long-term) and can have fatal complications. Early diagnosis, treatment and lifestyle modification can slow or inhibit the progression of the disease and reduce complications.
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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.