Engerix B Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Engerix-B [Hepatitis B Vaccine (Recombinant)] is a vaccine used to help prevent Hepatitis B. Common side effects include pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness.

Engerix-B is administered by intramuscular injection. Consult your doctor for the vaccination dosing schedule. Engerix-B may interact with steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and all vaccines you have recently received. During pregnancy, Engerix-B should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Engerix-B [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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Engerix B in Detail - Patient Information: Side Effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fussiness, irritability, crying for an hour or longer;
  • fast or pounding heartbeats; or
  • easy bruising or bleeding.

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • headache, dizziness;
  • low fever;
  • joint pain, body aches;
  • tired feeling; or
  • nausea, vomiting, stomach pain, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Engerix B (Hepatitis B Vaccine Recombinant) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Engerix B Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 doctor 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, seek immediate medical attention 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 your 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 report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Engerix B (Hepatitis B Vaccine Recombinant)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Engerix B FDA Prescribing Information: Side Effects
(Adverse Reactions)


ENGERIX-B (hepatitis b vaccine recombinant) is generally well tolerated. As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.

Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B (hepatitis b vaccine recombinant) and plasma-derived vaccines. In 36 clinical studies, a total of 13,495 doses of ENGERIX-B (hepatitis b vaccine recombinant) were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration. Frequency of adverse experiences tended to decrease with successive doses of ENGERIX-B (hepatitis b vaccine recombinant) . Using a symptom checklist,† the most frequently reported adverse reactions were injection site soreness (22%) and fatigue† (14%). Other reactions are listed below.

Incidence 1% to 10% of Injections

Local Reactions at Injection Site: Induration; erythema; swelling.

Body as a Whole: Fever ( > 37.5°C).

Nervous System: Headache†; dizziness.†

†Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.

Incidence < 1% of Injections

Local Reactions at Injection Site: Pain; pruritus; ecchymosis.

Body as a Whole: Sweating; malaise; chills; weakness; flushing; tingling.

Cardiovascular System: Hypotension.

Respiratory System: Influenza-like symptoms; upper respiratory tract illnesses.

Gastrointestinal System: Nausea; anorexia; abdominal pain/cramps; vomiting; constipation; diarrhea.

Lymphatic System: Lymphadenopathy.

Musculoskeletal System: Pain/stiffness in arm, shoulder, or neck; arthralgia; myalgia; back pain.

Skin and Appendages: Rash; urticaria; petechiae; pruritus; erythema.

Nervous System: Somnolence; insomnia; irritability; agitation.

Postmarketing Reports

Additional adverse experiences have been reported with the commercial use of ENGERIX-B (hepatitis b vaccine recombinant) . Those listed below are to serve as alerting information to physicians.

Hypersensitivity: Anaphylaxis; erythema multiforme including Stevens-Johnson syndrome; angioedema; arthritis. 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 CONTRAINDICATIONS).

Cardiovascular System: Tachycardia/palpitations.

Respiratory System: Bronchospasm including asthma-like symptoms.

Gastrointestinal System: Abnormal liver function tests; dyspepsia.

Nervous System: Migraine; syncope; paresis; neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell's palsy, transverse myelitis; optic neuritis; multiple sclerosis; seizures.

Hematologic: Thrombocytopenia.

Skin and Appendages: Eczema; purpura; herpes zoster; erythema nodosum; alopecia.

Special Senses: Conjunctivitis; keratitis; visual disturbances; vertigo; tinnitus; earache.

Reporting Adverse Events

The National Childhood Vaccine In jury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient's permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.18 The Act further requires the healthcare provider to report to the US Department of Health and Human Services via VAERS the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 4 hours, encephalopathy or encephalitis within 72 hours, or any sequelae thereof (including death).18,19 In addition, any event considered a contraindication to further doses should be reported. The VAERS toll-free number is 1-800-822-7967.

Read the entire FDA prescribing information for Engerix B (Hepatitis B Vaccine Recombinant) »


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.

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