"Patients with a past or current hepatitis B virus (HBV) infection can experience sometimes fatal HBV reactivation if they take any of nine direct-acting antivirals for hepatitis virus C (HCV) infection, the US Food and Drug Administration (FDA) a"...
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 of Engerix-B include:
- injection site reactions (pain, soreness, redness, swelling),
- sore throat,
- abdominal pain,
- loss of appetite,
- muscle pain, and
- flu-like symptoms.
Infrequently, temporary symptoms such as fainting, lightheadedness, vision changes, numbness or tingling, or seizure-like movements have happened after vaccine injections such as Engerix-B. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection of Engerix-B.
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 Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Engerix B Overview - Patient Information: Side Effects
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 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
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.
The most common solicited adverse events were injection site soreness (22%) and fatigue (14%).
In 36 clinical studies, a total of 13,495 doses of ENGERIX-B 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 events tended to decrease with successive doses of ENGERIX-B.
Using a symptom checklist, the most frequently reported adverse events were injection site soreness (22%) and fatigue (14%). Other events are listed below. Parent or guardian completed forms for children and neonates. Neonatal checklist did not include headache, fatigue, or dizziness.
Incidence 1% to 10% of Injections
Nervous System Disorders: Dizziness, headache.
Incidence < 1% of Injections
Infections and Infestations: Upper respiratory tract illnesses.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Metabolism and Nutrition Disorders: Anorexia.
Psychiatric Disorders: Agitation, insomnia.
Nervous System Disorders: Somnolence, tingling.
Vascular Disorders: Flushing, hypotension.
Gastrointestinal Disorders: Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting.
In a clinical trial, 416 adults with type 2 diabetes and 258 control subjects without type 2 diabetes who were seronegative for hepatitis B markers received at least one dose of ENGERIX-B. Subjects were monitored for solicited adverse events for 4 days following each vaccination. The most frequently reported solicited adverse events in the entire study population were injection site pain (reported in 39% of diabetic subjects and 45% of control subjects) and fatigue (reported in 29% of diabetic subjects and 27% of control subjects). Serious adverse events were monitored through 30 days following the last vaccination. Serious adverse events (SAEs) occurred in 3.8% of diabetic subjects and 1.6% of controls. No SAEs were deemed related to ENGERIX-B.
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for ENGERIX-B since market introduction (1990) are listed below. This list includes serious adverse events or events that have a suspected causal connection to components of ENGERIX-B.
Because these events are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Infections and Infestations
Blood and Lymphatic System Disorders
Immune System Disorders
Allergic reaction, anaphylactoid reaction, anaphylaxis. 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.
Nervous System Disorders
Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis.
Ear and Labyrinth Disorders
Respiratory, Thoracic, and Mediastinal Disorders
Skin and Subcutaneous Tissue Disorders
Musculoskeletal and Connective Tissue Disorders
Arthritis, muscular weakness.
General Disorders and Administration Site Conditions
Injection site reaction.
Abnormal liver function tests.
Read the entire FDA prescribing information for Engerix B (Hepatitis B Vaccine Recombinant)
Additional Engerix-B Information
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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